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Safety & EOHS

SAFETY PROCEDURE MANUAL

SAFETY PROCEDURE MANUAL

Certain work activities carry with them a degree of hazard which is considered more than normal. The purpose of this procedure is to identify these work activities. The use of Fire Permit is intended to ensure that every reasonable effort has been made to minimize the risk before the work to be authorised.

TABLE OF CONTENTS

  • FIRE PERMIT
  • EXCAVATION PERMIT
  • VESSEL ENTRY PERMIT
  • WORKING AT HEIGHT
  • MAINTENANCE WORK PERMIT
  • EQUIPMENT TAGGING
  • ACCIDENT / INCIDENT REPORTING
  • MAJOR ACCIDENT / INCIDENT REPORTING

PURPOSE : Certain work activities carry with them a degree of hazard which is considered more than normal. The purpose of this procedure is to identify these work activities. The use of Fire Permit is intended to ensure that every reasonable effort has been made to minimize the risk before the work to be authorised.

SCOPE : The procedure will be followed when ever welding, cutting, burning, drilling, soldering or any other open flame work is carried out within the factory premises except the Contractor’s workshop, bitumen melting area .

RESPONSIBILITY : It will be the responsibility of the Area manager / Area supervisor to ensure that no hot work is carried out without an authorised permit within his area of control.

MONITORING – Security Manager, EOHs Manager and Area manager will be responsible to ensure and monitor that no hot work is carried out without a valid permit within the plant premises.

RECORD KEEPING – Record of second copy of the permit will be kept and maintained by the permit issuing department.

AUTHORISATION – The hot work permit will be authorised for start of work by any one of the persons mentioned below between 08:30 Hrs to 17.00 hrs.

a) Production Manager

b) Engineering Manager

c) Plant Head / Location Head

For hot work jobs to continue after 1700 hrs. or to be carried out on Holiday / Sunday the permit will have to be specifically authorised by Plant Head / Location Head  and Area manager shall be responsible for it.

 PROCEDURE :

Form to be used: Fire Permit (Annexure-1) is prepared in duplicate.

Ist copy –  To be kept at Job site / Gate Office

IInd copy – Concerned Department (To be retained in the book)

A separate permit will be required for each job. The fire permit will have a definite starting and ending time. Separate permit is required beginning at 08:30 Hrs. each day.

The permit will be originated after job details have been discussed between operating and maintenance personnel. In no case advance date permit will be authorised.

Part A of the permit is initiated by maintenance supervisor / area supervisor indicating description, location, equipment details, date and time of start and finish.

The  area supervisor will then make necessary preparations at the job site as per check-list on the permit. He will initial at appropriate space after completion of all the preparations required.

The Area manager will check to ensure that all necessary precautions have been taken and will arrange a regular vigil till the job is completed.

Area manager / EOHS Manager / Area supervisor will conduct the explosive meter test (if required) and satisfy himself that the surroundings are safe for welding / hot work.

It is the responsibility of Maintenance supervisor / Manager to satisfy himself with the preparations made before signing on the permit.

A trained fire watch will be assigned to the job site. The name of this person will be entered on the permit and he will initial it indicating that he has assumed responsibility. A person assigned as fire watch should know what action to take in case of a fire and how to get additional help. He should be conversant with the use of fire extinguishers. He will ensure that no unsafe act or unsafe condition is being created by the working of the maintenance men.

AUTHORISATION OF THE PERMIT : After completion of all preparations and signatures by concerned personnel, the permit will be authorised for start of work by the authorised person.

Authorised persons for approving start of work are Production Manager / Engineering Manager for jobs around their own work areas. However, for the jobs to be carried out inside operating Flame proof production areas, the permit will have to be specifically authorised by the Plant Head / Location Head.

One fire watch may observe two jobs at the same time if authorised.

In case of a fire alarm, all the fire permit issued will get suspended till clearance to restart the work has been given by the authoriser.

While carrying out hazardous jobs, information must be given to the adjacent departments about the work in progress.

At completion or suspension of work at the end of the day (within the validity period), the maintenance supervisor will indicate time and date on the permit and return it to the issue department.

The fire watch will maintain a vigil for at least 10 minutes after the job has been completed & will ensured that all working tools & welding sets have been removed from the site.

PREPARATION FOR HOT WORK

Whenever practicable the equipment shall be moved to a designated safe area. If the equipment cannot be readily moved, all fire hazards in the vicinity shall be removed from the area.

Barriers in the form of fire resistant tarpaulins /  blankets shall be used to confine, heat, spark and slag.

Wall openings, holes and grated floor shall be covered to prevent discharge of hot material from one area to another.

When welding slag will be discharged from one floor level to another such as on metal grating floor, the fire watch shall monitor the place where slag will collect.

All flammable and combustible materials must be removed to a considerable distance so as to remove any chance of fire.

For hot work in confined space, vessel entry permit procedure must be additionally followed.

Safety & EOHS

SOP ON SAFETY MANUAL “PERMIT SYSTEM”

SOP ON SAFETY MANUAL “PERMIT SYSTEM”

Objective : To lay down a procedure for work permit system for the execution of  project/ maintenance /plant modification  jobs in safely.

Scope : This Standard Operating Procedure is applicable for all  plants/ operations.

Responsibility :

Monitoring – Security Officer, EOHs Manager and Area manager will be responsible to ensure and monitor that above mention work is carried out without a valid permit within the plant premises.

Record Keeping – Record of second copy of the permit will be kept and maintained by the permit issuing department.

Authorization – The hot work permit will be authorized for start of work by any one of the persons mentioned below between 08:30 Hrs. to 17:00 hrs.

a) Production Manager

b) Engineering Manager

c) Plant Head / Location Head

For hot work jobs to continue after 17:00 hrs. Or to be carried out on Holiday / Sunday the permit will have to be specifically authorised by Plant Head / Location Head and Area manager shall be responsible for it.

Abbreviations and Definitions

EOHS-Environment Occupational Health & safety

Procedure :

FIRE PERMIT

Form to be used: Fire Permit is prepared in duplicate.

Ist copy( white) – To be kept at Job site / Gate Office

IInd copy(Red) –  Operating Department (To be retained in the book)

The permit will be originated after job details have been discussed between operating and maintenance personnel. In no case advance date permit will be authorized.

Permit is initiated by maintenance Engineer /Supervisor /Officer / Executive / area supervisor/officer/Executive indicating description, location, equipment details, date and time of start and finish.

The area supervisor/officer/Executive will then make necessary preparations at the job site as per check-list on the permit. He will initial at appropriate space after completion of all the preparations required.

The Area manager will check to ensure that all necessary precautions have been taken and will arrange a regular vigil till the job is completed.

Area manager / EOHS Manager/EOHS Officer will conduct the explosive meter test (if required) and satisfy himself that the surroundings are safe for welding / hot work.

It is the responsibility of Maintenance /Area Manager to satisfy himself with the preparations made before signing on the permit.

A trained fire watch will be assigned to the job site. The name of this person will be entered on the permit and he will initial it indicating that he has assumed responsibility. A person assigned as fire watch should know what action to take in case of a fire and how to get additional help. He should be conversant with the use of fire extinguishers. He will ensure that no unsafe act or unsafe condition is being created by the working of the maintenance men.

AUTHORIZATION OF THE PERMIT : After completion of all preparations and signatures by concerned personnel, the permit will be authorized for start of work by the authorized person.

Authorized persons for approving start of work are Production Manager / Engineering Manager for jobs around their own work areas. However, for the jobs to be carried out inside operating Flame proof production areas, the permit will have to be specifically authorized by the Eng. Head /Plant Head / Location Head.

One fire watch may observe two jobs at the same time with in same area if authorized.

In case of a fire alarm, all the fire permit issued will get suspended till clearance to restart the work has been given by the authorizer.

While carrying out hazardous jobs, information must be given to the adjacent departments about the work in progress.

At completion or suspension of work at the end of the day (within the validity period), the maintenance Engineer  /Officer / Executive will indicate time and date on the permit and return it to the issue department.

The fire watch will maintain a vigil for at least 10 minutes after the job has been completed & will ensured that all working tools & welding sets have been removed from the site.

Preparation for Hot Work

Whenever practicable the equipment shall be moved to a designated safe area. If the equipment cannot be readily moved, all fire hazards in the vicinity shall be removed from the area.

Barriers in the form of fire resistant tarpaulins / blankets shall be used to confine, heat, spark and slag.

Wall openings, holes and grated floor shall be covered to prevent discharge of hot material from one area to another.

When welding slag will be discharged from one floor level to another such as on metal grating floor, the fire watch shall monitor the place where slag will collect.

All flammable and combustible materials must be removed to a considerable distance so as to remove any chance of fire.

For hot work in confined space, vessel entry permit procedure must be additionally followed.

For hot work at height, height permit procedure must be additionally followed. 

EXCAVATION PERMIT

Excavation permit will be prepared in duplicate

Ist Copy(White) -To be issued to the person carrying out the   excavation job (at job site / gate office)

IInd Copy(Red)– To be retained in the book.

The Supervisor / Engineer /Officer / Executive supervising the excavation will generate the Excavation work permit

After necessary arrangement and ensuring that no drainage, sewer lines, hydrant lines going underneath, the Engg. Officer / Executive/ Supervisor will endorse the permit.

He will then get it endorsed from the electrical in charge / supervisor /Officer / Executive regarding the electrical lines passing underneath or in proximity of the area

Then the Supervisor supervising the excavation will get the permit cleared from the Area manager / Engg. Manger for any hazardous situation in and around the site. The Area manager will take necessary precautions and advise specific precautions to be taken by the persons involved in doing the excavation job including use of PPE (personal protective equipments, if necessary.)

When it is ascertained that the area is safe for excavation, the authorised person will authorise the permit for start of the job..

After the excavation job has been completed, the Supervisor supervising the excavation will do the refilling of the excavated site, clear it from the debris and get the permit endorsed from the Area manager and hand it over to Engineering Manager for record.

A fresh excavation permit will be required each day if a job has to be carried over to next day. In case the excavation activity is to continue for prolonged period (days), each day the Supervisor supervising the excavation will obtain signature of the Area manager / Supervisor regarding safety clearance for going ahead with the job.

Guidelines for excavation jobs shall be followed while undertaking any excavation job.

GUIDELINES FOR EXCAVATION JOBS

Whenever an excavation is under progress, the excavated part will be cornered / barricaded properly so that no body falls / stables.

If the pit is more than 5 feet in depth, shoring arrangement shall be given to prevent the each from caving in.

While carrying out digging the persons doing the job should be warned to discontinue the job and report if any odour / gas suddenly emanates from within the ground.

Buddy system should be followed for excavation job (i.e. there should always be more than one person doing excavation jobs).

The workmen should be provided with safety goggles if concrete surface is to be excavated. There should not be any flammable material in the vicinity when concrete surface is being broken. Explosive meter test should be carried out to confirm the presence / absence of flammable vapours.

When it is known that electrical cables are going underneath, supervisor will ensure that the electrical connections are duly disconnected.

The Supervisor will personally supervise the job when excavation is being carried out with cables / pipelines underneath so that no damage takes place.

When pipelines or electrical cables are known to pass underneath, the ground will be made soft by spraying water before commencing the excavation.

The Supervisor will inform the Engineering Manager regarding completion of work so that the electric cables can be energised. The electrical dept. will test the site for any electrical leakage before clearing the site for normal use.

When pipelines are going underneath, the excavated portion will be filled only after ensuring that there is no leakage of material.

Vessel entry Permit

Vessel entry permit form shall be prepared in duplicate

Ist copy :  To be available at job site

IInd copy : To be retained in the book by operating dept.

Separate permit is required for each vessel entry. Vessel entry permit will have a definite starting and ending time.

A fresh vessel entry permit will be required each day if a job has to be carried over to next day.

It is the responsibility of concerned area Supervisor to initiate a vessel entry permit and make necessary preparations.

The job site will be inspected and checked for necessary preparations by the Area manager / Area manager.

It is the responsibility of the Maintenance Supervisor / Foreman to satisfy himself with the preparations made. In case the job involves hot work inside a vessel, he will obtain a fire permit duly authorised by Plant Head / location Head / Engineer Manager / Production Manager as per the procedure.

Only after all preparations have been made and permit signed by all concerned personnel, it shall be authorised for start of work by the authorised person.

At the expiry of the vessel entry permit or completion of job within the validity period, the maintenance Forman shall indicate the date and time of completion / suspension of work and return it to operating department.

In the event of an emergency alarm / leakage of any chemical, the vessel attendant shall immediately inform the person working inside the come out. The work shall remain suspended till specific clearance to restart the work is given. Re-entry will be permitted only after approval by a person authorised for issuing permit.

Outside observer will not go inside the confined space in case of emergency, but only trained staff should be allowed to do so for rescue, if required and that too only with the aid of SCBA and / or the correct PPE required by the situation.

Inspection of confined space should be carried out before handover of the equipment to the operative staff. He should check the quality of work, reconnect all disconnected lines in proper way, remove all tools, accessories and other removed parts etc. from the confined space / vessel.

It must be confirmed that no inadvertent changes are made in the confined space.

Preparation of vessel / confined space for entry shall be carried out as per the guidelines given along with. Guidelines for entry inside confined space should be followed

PREPARATION FOR VESSEL ENTRY – GUIDELINES

Before an entry, the vessel or confined space shall be made free from inflammable and toxic materials.

The confined space / vessel shall be cleaned thoroughly according to the nature of product and residue, the best and most practical method known v.z. hot or cold water wash / flush, steam wash etc. It shall be drained / cleaned air purged and if steam had been used, to be allowed to cool with fresh air.

The vessel must be isolated as per tag system for equipment under maintenance. (Physical disconnection of inlet and outlet pipelines or slip binding of flanged joints must be carried out).

For vessels fitted with internal power driven equipments like agitators, additional precautions on electrical isolation must be taken. Physical disconnection must be carried out by removing electrical circuit breaker from the switchgear or by removing wire splices in junction box and by removing mechanical drive components such as V-belt, chain, drive, couplings etc.

The vessel shall be thoroughly checked to ensure that there is no prominent odour of any chemical / solvents in the vessel and the person working inside can breathe easily.

The following gas test shall be carried out by Area manager / EOHS Manager/ Area Supervisor

Explosimeter test : It should indicate not more than 5%  of LEL

Oxygen Content: It should essentially be in between 19.5% and 22.0%.

In case hot work is to be done inside a vessel, the person entering the vessel should produce a spark inside, before actually entering the vessel for work.

The person entering the vessel shall make use of safety belt and lifelines, supplied air mask and other personal protective equipments as may be prescribed.

Regular high voltage lights are not allowed for work inside a vessel. Low voltage (24V) only may be used.

The vessel shall be provided with adequate ventilation. This may be achieved by an air blower or air purge.

A vessel attendant shall be assigned to the vessel opening. The person shall not let the vessel remain unattended under any circumstances when a person is working inside.

When the job is in progress, a warning sign ‘CAUTION – VESSEL ENTRY’ shall be displayed prominently outside the vessel.

PROCEDURE FOR ENTRY INTO CONFINED SPACE :

All persons must wear protective clothing with a lifeline attached. The lifeline shall be equipped with a double lock snap. Tension or lifeline should be maintained when a person is entering or leaving the confined space.

Emergency exit system should be discussed and provided before persons enter inside confined area / vessel. When person is coming out of tank whether he is climbing on his own or being hoisted tension must be maintained at all times on the lifeline.

The vessel attendant should keep watch in such a manner so as to be able to see the person inside at all times. This person must attend the free end of the lifeline at all times.

Minimum number of manpower should be allowed inside a confined space for work at one time

Work at height Permit

It will be the responsibility of the Area supervisor to ensure that the area is checked for safe work at height using scaffolding or safety belt.

The Maintenance manager / supervisor with Area supervisor to ensure that adequate arrangement has been made to carry out the job safely by providing suitable platform / metallic ladder etc.

Area Supervisor will initiate the work at height ( Attached Form  ) if the site is 12 ft. or more in height & Maintenance engineer or supervisor will sign the permit to endorse that adequate safety arrangements are made to carry out the job.

In case the job is to be carried out in any area other than module then maintenance engineer or supervisor will initiate the permit.

The Area manager or Area manager will inspect the work at height permit & the site, once he has ascertained that the site of operation is totally safe ,he will finally authorize the work at height permit in case the job is carried out in area other than module then Engineering Manager will authorise the permit.

It is the responsibility of the Maintenance manager or supervisor to check the area on the day of work and issue permit every day before starting the work.

The original copy of the work at height permit will be available at the job site and the second copy will be retained by the department / area where work is to be carried out.

LIMITATIONS :-

No wooden cat ladders will be allowed in the plant.

No work will be carried out unless the permit has been obtained in the specified form (Form Attached) and that the same has been duly filled signed by all concerned.

In case of fire alarm, all permits issued for work at height will get suspended till clearance to restart the work has been given by the authoriser

GENERAL :-

After completion of the job, Maintenance Supervisor / Maintenance manager will indicate the date and time of completion of the job and keep for record.

Maintenance Work Permit

FOR MECHANICAL / ELECTRICAL / INSTRUMENTAL MAINTENANCE

Whenever an equipment needs some maintenance, the Area Supervisor / Manager shall initiate a Maintenance work request & work permit.

The Area manager / Supervisor will hand over the work permit to maintenance Supervisor / Manager giving details of equipment and the breakdown.

It is the responsibility of the concerned Area Supervisor / manager to make all the necessary isolation and keep the equipment ready for maintenance as per safety procedure on Equipment Tagging System

The Maintenance Supervisor / Manager will depute mechanics to attend to the breakdown giving them necessary safety instructions for the particular job.

The Mechanic assigned for the job shall report to the Area Supervisor / Manager and obtain a Work Permit in writing before actually starting the work.

After completion of work, the Mechanic will obtain clearance from the concerned Supervisor / Manager and hand over the Work Request and Work Permit copy to Maintenance Supervisor / Manager for record

CIVIL JOBS

The type of jobs covered under the procedure will include painting, white-washing, floor cleaning / polishing, breaking of walls, masonry repairs. Same Procedure as above will be followed.

GENERAL

The procedure shall apply for all jobs even if a particular job is to be done by Contractor personnel.

For any new project work, it will be the responsibility of the work co-ordinator to issue Work Permits to personnel working. The important safety instructions shall be given in writing and Work Permit shall be revalidated on each day of work.

If a job in one area is expected to affect the adjacent area as well, specific written clearance shall be obtained from that department also.

FIRE PERMIT CHECK LIST

  1. Equipment inspected personally
  2. Equipment drained and flushed
  3. Electrically isolated
  4. Work area clear and safe
  5. Proper ventilation
  6. Sewer openings closed
  7. Fire hydrant point / hoses checked
  8. Fire extinguisher available (Specify type)
  9. Fire watch, Name Signature
  10. Personal protective equipments (specify)
  11. Explosive meter test

MAINTENANCE WORK PERMIT

  1. Equipment electrically isolated
  2. Equipment mechanically isolated
  3. Flushed and cleaned
  4. Tags put
  5. Personal protective items Issued /available
  6. Excavation/Fire/Vessel entry
  7. Permit issued (if applicable)
  8. Specific instructions (if any)

VESSEL ENTRY PERMIT

  1. Equipment isolated by Physical disconnection / slip binding.
  2. Equipment drained, cleaned and purged.
  3. Electrical isolation of power driver internal equipments.
  4. Check Area for any hazardous materials present nearby.
  5. No obnoxious odour and safe to breathe / work inside.
  6. Personal protective equipment – i) Safety Belt, Lifeline ii) Supplied air mask iii) Informed adjacent area.
  7. Fire fighting, equipments (specify).
  8. Has warning sign been put ?
  9. Ventilation for the vessel.
  10. Lighting arrangement provided ?
  11. Person entering the vessel,
  12. Vessel Attendant.
  13. Explosimeter Test (if required)
  14. Oxygen Test

SAFETY PERMIT FOR WORK AT HEIGHT   

  1. Scaffolding
  2. Safety Belt with arrangement for fixing
  3. Safety Helmet
  4. Other Safety Measure taken / required for the job
  5. Safety Instruction ( If any )
  6. Checked for operation by Production Supervisor
  7. Checked by Maintenance Engineer / Foreman / Civil Supervisor
  8. I declare that the above mentioned Safety measures have been taken and permit for work at height may be issued.
Quality Assurance

SOP for Numbering of compactor and Storage of documents in the compactor system of Documentation cell-QA.

SOP for Numbering of compactor and Storage of documents in the compactor system of Documentation cell-QA

Objective : To lay down a procedure for numbering of compactor and storage of documents in the compactor.

Scope : This Standard operating procedure is applicable for formulation plant.

Responsibility :

QA Officer/Executive Doc Cell : Shall be responsible for Storage of documents and numbering of  compactor system as per this SOP.

Manager- QA : Shall be responsible for compliance of this SOP.

Procedure :

Numbering procedure of compactor system :

Compactor shall be used for storage of Master SOPs, Audit reports and contract manufacturing documents, Change Control, Deviation, Non conformance records and market complaint documents, Vendor documents, Validation documents, Product masters, raw material specifications, STPs and GTPs and packaging specifications, STPs and GTPs etc.

Numbering of Compactor system shall contain 7 characters.

Compactor system has eleven block.

First character represents the block and shall be denoted as ‘B’.

Second and third character contains digits starting from 01,02,03……. and so on showing the number of compactor.

Fourth character shall be a dash. ‘-‘

Fifth character shall represents column, and is denoted by ‘C’

Sixth and Seventh character shall represents the block numbering and designated as 01,02 ,03 and so on.

For example 2nd column of 5th block shall have the number as ‘B 05- C 02’

Note:-Each Block is numbered starting from B 01- C 01 to B 10- C 15.

Storage of Documents in Compactor system

Starting from left side blocks B1 and B2 shall be used for storage of validation documents and qualification documents.

Block B3 and B4 shall be used for storage of Master SOPs, Change control, deviation, Non conformance records and market complaint documents, etc… designating one or two racks for each document as required.

Blocks B5 to B8 shall be used for storage of product masters as per there number.

Blocks B9 to B11 shall be used for storage of raw material specifications, STPs and GTPs, Packaging material specifications, STPs and GTPs.

On each block, list of stored documents in that block shall displayed for easy traceability of the documents.

Block 1 to 5 shall be used for storage of control samples. Control samples shall be stored alphabetically. Each column shall be used for a single alphabet i.e. in each column six products of same alphabet shall be stored. The designation of alphabet to column shall be done in right to left – left to right – right to left fashion.. If there are no products for a particular alphabet than instead of allotting a column, 2 racks will be left blank for that alphabet, so that in future if any product comes with that alphabet than whole shifting of control samples can be avoided. If the name of more than six alphabets start with same alphabet than starting from column adjacent to column “Z” column shall be alphabetically allotted.

Block 6 to 14 shall be used for storage of BMRs. BMRs shall be stored alphabetically. Two columns shall be used for a single alphabet and each product two racks shall be designated for each product i.e. in each column three products shall be stored. The designation of alphabet to column shall be done in right to left – left to right – right to left fashion. If there are no products for a particular alphabet than instead of allotting a column, one column shall be left blank for that particular alphabet, so that in future if any product shall come with that alphabet then whole shifting of BMRs can be avoided. If the name of more then six products alphabets start with same alphabet than starting from column adjacent to column “Z” column shall be alphabetically allotted.

Numbering procedure for Compactor II

Compactor II shall be represented as Com II

In “Compactor II” there are 11 blocks, numbered as B1, B2, B3… so on.

Each block has 3 columns numbered as C1, C2, and C3.

And each column has 5 racks numbered as R1, R2, R3, R4 and R5.

So, first rack of fourth column of eighth block in Compactor I shall be numbered as Com II-B8C4R1

Compactor II shall be used for storage of Master SOPs, Audit reports and contract manufacturing documents, Change control, deviation, Non conformance records and market complaint documents, Vendor documents, Validation documents, Product masters, raw material specifications, STPs and GTPs and packaging specifications, STPs and GTPs etc.

Starting from left side blocks B1 and B2 shall be used for storage of validation documents and qualification documents.

Block B3 and B4 shall be used for storage of Master SOPs, Change control, deviation, Non conformance records and market complaint documents, etc… designating one or two racks for each document as required.

Blocks B5 to B8 shall be used for storage of product masters as per there number.

Blocks B9 to B11 shall be used for storage of raw material specifications, STPs and GTPs, Packaging material specifications, STPs and GTPs.

On each block, list of stored documents in that block shall displayed for easy traceability of the documents.

Quality Assurance

SOP on Line Clearance

SOP on Line Clearance

Objective : To lay down a procedure for Line Clearance before proceeding to another product/ batch or step in the production.

Scope : This Standard Operating Procedure is applicable for formulation plant.

Responsibility :

Executive/ Officer/ Supervisor- Production / Stores to ensure line clearance as per this SOP.

Executive/ Officer- IPQA to give line clearance.

Head- QA/ designee to ensure compliance of this SOP.

Procedure

Ensure that all the cleaning of the equipment is done as per the respective SOP and cleaning details are recorded in the Machine Log sheet/ book and area is cleaned as per the respective SOP.

Before starting the new product in the Equipment or Area or Line ensure that all the equipments are cleaned and affixed with ‘CLEANED’ label.

Ensure and check visually that the previous product items e.g. labels, used polybags, use gloves, any raw / packaging materials are removed from the area.

Ensure that all Filled / Unfilled Containers, Printed / Coded Materials, Bulk Materials, Finished Goods, Scrap, Use Aids have been removed from the line. Special care must be paid for the difficult to clean areas e.g. under the packing belt, packing machine etc.

Line Clearance Checklist dispensing Area

  1. Correctness and cleaning status of Dispensing Aid Set No.
  2. Dispensing Booth cleaning status
  3. Weighing Balances cleaning and calibration status
  4. Filter cleaning status
  5. Hygrometer cleaning and calibration status
  6. Area Cleaning status
  7. Environmental conditions

Line Clearance Checklist Packing Area

  1. Check the top, below, around the belt for the remnants of previous product
  2. Check that line board is clean
  3. Check the detail of next product on line board
  4. Stereos of previous batch are destroyed
  5. Online/Batch Coding machine/inkjet printer and around area
  6. BOPP taper machine and around area
  7. There shall not be any remnants of previous batch
  8. Cleanliness of online checkweigher
  9. Packing Accessories Checked
  10. Correct Pack Material on the Line
  11.  Weighing balance
  12. Cartoner and its around area
  13. Bulk Packing Machine and its around area
  14. Cartoner  and its area
  15. Area cleaning

 

Quality Assurance

SOP for Assigning of Numbers for Qualification Documents, Protocols and Reports

SOP for Assigning of Numbers for Qualification Documents, Protocols and Reports

Objective : To lay down a procedure for assigning of number for qualification documents, protocols and reports.

Scope : This Standard Operating Procedure is applicable for assigning of number for various qualification documents, protocols (validation protocols, various study protocols like stability studies, etc.) and the reports prepared at all formulation sites. It also gives the numbering procedure for Site Master File(s) and Validation Master Plan(s).

Responsibility :

All concerned HODs shall be responsible for implementing this SOP while numbering qualification documents, protocols and the reports.

Executive, QA shall be responsible for assigning numbers to qualification documents, protocols and their reports.

Head, QA shall be responsible for compliance of this SOP.

Abbreviations and Definitions

Qualification Documents : Qualification Documents contain studies, which establish confidence that the process equipment and ancillary systems are capable of consistently operating within established limits   and tolerances.

HVAC : Heating Ventilation and Air Conditioning

Validation: The documentation act of demonstrating that any procedure, process, equipment, material, activity or system will consistently lead to the expected results.

Validation Protocols : A document with pre-determined approved study plan stating how the validation will be conducted and also enlists the acceptance criteria. It will specify who will conduct the various tasks.

Validation Reports : A document that summarizes the results of acceptance testing and presents a conclusion that all requirements of the validation protocol have been addressed.

Procedure :

Numbering of Qualification Documents

Numbering of qualification documents/validation protocols shall be done as per the following procedure:

QS/Type of Document–Equipment Number or System Number–XX/RNAY

The first character shall be ‘Q’ for Qualification.

The second character ‘S’ shall represent name of the site or location of formulation plant where these qualification documents shall be implemented . If any new site is developed then first alphabet of the name of the site shall be used. In case the first alphabet of name of new site is same as the first alphabet of the existing site then second or third alphabet of the name of new site shall be used.

The third character shall be a ‘/’ (slash).

The fourth and fifth characters shall denote the type of qualification document e.g. IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) or any other document “List of Codes for Different Qualification Documents and Validation Protocols”.

The sixth character shall be a ‘–’ (dash).

The next characters will be Equipment Id. number of a particular department (e.g. EQ/PR/001 is the first equipment of Production) or System Number like HVAC or Water Systems (e.g. SY/EN/001 is the first system of Engineering like HVAC or SY/PR/001 for first system in Production department like Water Systems).

The next character shall be a ‘–’ (dash).

The next two characters shall be ‘XX’ depicting the revision number of the Qualification Document. These two characters shall be ‘00’ for new equipment and shall be ‘01’ if the equipment is re-qualified for any reasons.

The next character shall be a ‘/’ (slash).

The next two characters shall be ‘RN’ where ‘R’ denotes report and ‘N’ is the number of times a particular study is carried out completely for the particular ‘Parent Qualification Document’. The report numbering shall not be done for addendum/addenda and the studies related to a particular addendum/addenda shall be part of the respective addendum/addenda itself.

e.g. First report of Performance Qualification document of an equipment installed at production department at Goa shall be QG/PQ-EQ/PR/001–00/R1 and similarly second report shall be QG/PQ-EQ/PR/001–00/R2.

The report number indicates the number of times the qualification has been conducted for the same equipment on the same qualification document with a particular revision number.

The last two characters shall be ‘AY’ where A denotes ‘Addendum’, if any, attached to qualification document and Y shall be numeric character starting from 1 to 9, representing the number of times the addenda have been added to the qualification document. These two characters shall be suffixed only if any addendum is added e.g. First report of Performance Qualification document of an equipment installed at production department at Goa shall be and if, first addendum is included after first report then the numbering shall be QG/PQ-EQ/PR/001–00/R1A1 and after second addendum, the numbering shall be QG/PQ-EQ/PR/001–00/R1A2.

If after some pre-decided time interval the Performance Qualification of a particular system is to be carried out again then the numbering shall be as follows: e.g. for HVAC systems.

At zero month : QG/PQ-SY/PR/001–00/R1

At second month : QG/PQ-SY/PR/001–00/R1A1 (when first addendum is included)

At fourth month : QG/PQ-SY/PR/001–00/R1A2 (when second addendum is included)

After six months (Re-qualification) : QG/PQ-SY/PR/001–00/R2

(at pre-decided date, when complete studies including those of addendum are done as a part of complete protocol, the R2 is suffixed at the end)

The addendum shall be added in cases where partial additional qualification shall be carried out on the same equipment for any new part installed on the same equipment, depending on the case where additional part is not altering the major functionality of the equipment. Every time the Qualification Document is revised the numbering of Addendum shall be made part of parent document and shall follow numbering as discussed earlier. On first revision the document shall have following numbering QG/PQ-EQ/PR/001–01/R1 with R1 being the first report for that document.

Note: The addendum/addenda shall be authorized by same persons responsible for signing the parent document or by their designee in absence.

Numbering of Validation Documents

The report numbering of validation documents shall be as follows:

PS/Type of Validation/Department XXX-YYAZ

The first character shall be ‘P’ for Protocol.

The second character ‘S’ shall represent name of the site or location of formulation plant where these qualification documents shall be prepared. If any new site is developed then first alphabet of the name of the site shall be used. In case the first alphabet of name of new site is same as the first alphabet of the existing site then second or third alphabet of the name of new site shall be used.

The third character shall be a ‘/’ (slash).

The next two characters shall be the type of validation document as per the form tilted “List of Codes for Different Qualification Documents and Validation Protocols” e.g. PV for Process Validation.

The name of the department responsible for the preparation of the document shall be given by two characters “List of Department Names and Codes”.

The next three characters shall represent serial numbers of document in ‘XXX’ format starting from 001 to 999 for each type of validation protocol.

The next character shall be a ‘-’ (dash).

The next two characters ‘YY’ shall represent the revision number (if any). These two characters shall be ‘00’ for new process or method and shall be ‘01’ if the same process or method is re-validated for any reasons.

The last two characters shall be ‘AZ’ where A denotes ‘Addendum’, if any, attached to validation document and Z shall be numeric character starting from 1 to 9, representing the number of times the addenda have been added to the document. The addendum shall be added in cases where partial additional validation, revalidation shall be carried out on the same process or equipment or for any new part installed on the same process or method, depending on the case where additional part is not altering the major functionality of the process or method. In case of a new validation document or if there is no change in the status of the validation document or protocol, then no addendum number shall be written e.g. if the partial process or method validation/ revalidation is planned with first addendum, after the approval of initial document, the Validation Document shall be numbered as PG/PV/PR001–00A1 with its parent document with no addendum being PG/PV/PR001–00

After any revision, all addenda, if any, appended to the validation documents and protocols shall be merged with the existing protocol to form one complete document and addendum number at the new revision number shall again start at zero. The revision of protocol shall invite complete revalidation work and report number shall again start at zero (0).

Note: The addendum/addenda shall be authorized by same persons responsible for signing the parent document or by their designee in absence.

Numbering of Report for Validation Document:

The numbering of report for Validation Document shall be exactly same as discussed for the parent document with the only difference being the first character. The first character ‘P’ which stands for Protocol shall be replaced by ‘R’, which denotes Report.

The report numbering for first Process Validation Protocol for Goa production (PG/PV/PR001–00) shall be RG/PV/PR001–00.

The report number indicates the number of times the partial or re-validation has been conducted for the same equipment / process on the same validation document with a particular revision and addendum number.

Numbering of Miscellaneous Documents :

Site Master File

The numbering of Site Master File shall be as follows: SMF/S/XX-RN

First three characters ‘SMF’ are abbreviation of Site Master File.

The next character shall be a ‘/’ (slash).

Next character ‘S’ shall be site e.g. G-Goa, B-Baddi,  etc.

The next character shall be a ‘/’ (slash).

The next two characters ‘XX’ shall be code of Plant/Block/Section at a particular site e.g. we can have more than one production sites at Goa or Baddi or we can have more than one production blocks dedicated for production of entirely different ranges of products.

The next character shall be a ‘-’ (dash).

The next two characters ‘RN’ shall be revision number.

The Site Master File of Goa one of its Plant (Location Code: 01), at its second revision shall be numbered as SMF/G/01-02.

Validation Master Plan :

The numbering of Validation Master Plan shall be as follows:

VMP/S/XX-RN

First three characters ‘VMP’ are abbreviation of Master Validation Plan.

The next character shall be a ‘/’ (slash).

Next character ‘S’ shall be site e.g. G-Goa, B-Baddi etc.

The next character shall be a ‘/’ (slash).

The next two characters ‘XX’ shall be code of Plant/Block/Section at a particular site e.g. we can have more than production sites at Goa or Baddi or we can have more than one production blocks dedicated for production of entirely different ranges of products.

The next character shall be a ‘-’ (dash).

The next two characters ‘RN’ shall be revision number.

The parent Validation Master Plan for Pharma Plant (Site Code: 01) at Goa formulation plant shall be numbered as VMP/G/01-00.

Control of Protocols and Reports :

Concerned person(s), who is/are responsible for preparing the qualification or validation documents, protocols and reports from various departments, shall obtain number for qualification documents and protocols from QA.

QA person shall allocate the number and fill the details.

The various documents and their reports shall be approved by the responsible departments heads or their designee and finally by Head, Quality Assurance or his / her designee.

Any changes in the validation protocols and qualification documents shall be done through the Change Control (Refer SOP titled “Change Control”).

Master Copies of all protocols and reports shall be retained with Quality Assurance Department. All pages of the original copy shall be stamped as ‘MASTER COPY’ on the front side of each page.

If necessary, controlled copy may be issued to the concerned department(s).

The distribution and retrieval of qualification documents, protocols and reports whose master copy is retained by Documentation Cell (Quality Assurance) to concerned departments shall be done as per SOP titled “Document and Data Control”.

Quality Assurance

SOP for Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products

SOP for Assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number to the Drug Products

Objective : To lay down a procedure for assigning number to Master Formula Card, Master Formula and Packaging Formula of a Drug Product.

Scope :  This Standard Operating Procedure is applicable for assigning Master Formula Card Number, Master Formula Number and Packaging Formula Number in the relevant documents i.e. Master Formula Card Number to Master Formula Cards, Master Formula Number to manufacturing TDs for manufacturing procedure and Packaging Formula Number to packaging TDs for packaging procedure for a drug products, which shall be manufactured at the formulation plant.

In case of other locations, the relevant documents shall bear Master Formula Number and Packaging Formula Number as per the procedure defined in SOP. At the time of revision of manufacturing TDs for these locations, the same shall be given Master Formula Number as per the procedure defined in this SOP. In any case, if a manufacturing TD for other locations bears a Master Formula Number as per this SOP, its all related Packaging TDs shall always bear the Packaging Formula Number as per this SOP. At the time of revision of packaging TDs or preparation of new packaging TDs for these locations, the TDs shall be given Packaging Formula Number corresponding to the Master Formula card Number applicable for that location. For instance, if a new packaging TD is prepared or the existing packaging TD is revised for the packing of a product manufactured with manufacturing TDs bearing Master Formula Number as per the procedure discussed in SOP, such packaging TD shall bear the Packaging Formula Number as defined in this SOP, else the packaging TDs shall be given new Packaging Formula Number as per the procedure discussed in this SOP.

Responsibility :

Scientist, Documentation Cell (R&D) shall be responsible for assigning Master Formula Card Number in the Master Formula Cards.

Scientists, Process Development shall be responsible for assigning Master Formula Number in the Technical Directions (manufacturing procedure).

Scientist, Packaging Development shall be responsible for assigning Packaging Formula Number in the Technical Directions (packaging procedure).

Abbreviations and Definitions

Master Formula Card Number: This number shall be allotted to the controlled document called Master Formula Card enclosing formulae and procedure in brief for the manufacturing and packaging of the product. This document shall be implemented at the time of technology transfer of manufacturing process from R&D to the manufacturing location.

Master Formula Number: This number shall be allotted to the TDs detailing manufacturing procedure.

Packaging Formula Number: This number shall be allotted to the TDs detailing packaging procedure.

TDs: Technical Directions

Procedure :

Assigning Master Formula Card Number

Master Formula Card Number shall be of six or seven numeric characters.

First and (Second character in case if location code is 10 till 99) shall be numeric code (shall be termed as plant code) denoting manufacturing location. For Goa manufacturing location the code shall be ‘1’ and for Baddi location it shall always be ‘2’. Similarly for other locations including contract manufacturing locations the codes can be given from 3 onwards up to 99. For e.g. if ‘X’ is the 10th location, then Location code given to it is 10.

Second, Third and four characters (or Third, fourth & fifth character) shall be the unique numeric product identity characters to be assigned to the product as per SOP titled ‘Assigning Item Codes to Raw Materials, Packaging Materials, In-process Materials and Finished Products’.

Last two characters i.e. fifth & sixth (or sixth & seventh) shall represent the revision level of the Master Formula Card (i.e. starting from 00 to 99)

E.g. Master Formula Card Number for the Master Formula Card for Nimesulide tablets 100 mg) with 015 three unique product identity characters, prepared first time for Goa location, shall be 201500 and first revision of the Master Formula Card shall reflect Master Formula Card Number as 201501 whereas for location code 20 location then Master formula card number shall be 2001500 for that location prepared for the first time and first revision of Master formula card number as 2001501.

Assigning Master Formula Number :

All Technical Directions detailing manufacturing procedure shall be given eight or nine alphanumeric characters

First four (or five characters in case of location code is 10 and so on till 99) of the Master Formula Number shall always be the first four or five characters of the Master Formula Card Number .

Fifth (or Sixth character) shall be an alphabet starting from ‘A’ and shall denote the batch size.

Sixth (or Seventh) character shall be ‘­­–’ (dash)

Last two characters i.e. seventh & eight (or eight & ninth) shall represent the revision level of the Technical Directions (i.e. starting from 00 to 99)

e.g. Master Formula Number for the Technical Directions (manufacturing procedure) for Nimesulide tablets 100 mg with 015 three unique product identity characters, prepared first time for Goa location with one batch size, shall be 2015A-00 and first revision of the same Technical Directions shall reflect Master Formula Number as 2015A-01. whereas Master formula number for technical directions ( manufacturing procedure) for Nimesulide tablets 100 mg with 015 three unique product identity characters, prepared first time for 10th location( whenever applicable) and so on  with one batch size, shall be 10015A-00 Similarly for the subsequent batch sizes, the relevant Technical Directions (first versions) shall bear Master Formula Number as 2015B-00, 2015C-00, 2015D-00 for Baddi Location and Master formula number as 10015B-00,10015C-00,10015D-00 for 10th location(whenever its applicable).

Assigning Packaging Formula Number :

All Technical Directions detailing packaging procedure shall be given twelve or thirteen alphanumeric characters.

First four (or five characters) of the Packaging Formula Number shall always be the first four or five characters of the Master Formula Card Number

Fifth & sixth (or sixth and seventh) characters shall be the serial number of packaging formula number (Technical Directions) starting from 01 to 99 i.e. a product manufactured with one Master Formula Number can be packed in different pack sizes so different TDs (packaging procedures) bearing different packaging formula numbers (Serial number) shall be prepared.

Seventh (or eight character) shall denote the supply as given below:

‘S’ shall denote product for Sale

‘P’ shall denote Physician sample

‘C’ shall denote product for Clinical Trial

‘G’ shall denote product for Government Supply

Eight & nine (or Nineth & tenth characters) shall be market codes, for more details refer SOP titled ‘Assigning Item Codes to Raw Materials, Packaging Materials, In-process Materials and Finished Products’ , defining procedure for assigning the item codes to Finished Products.

Tenth (or Eleventh character) shall be ‘­­–’ (dash)

Last two characters i.e. eleventh & twelveth (or twelfth & thirteen) shall represent the revision level of the Technical Directions (i.e. starting from 00 to 99)

e.g. First Packaging Formula Number for the first version of Technical Directions (packaging procedure) for Nimesulide tablets 100 mg for Baddi location to be prepared against the Technical Directions with manufacturing formula number 2015A-00 (or for its subsequent revisions, as applicable), for sale in the domestic market,  shall be 201501S00-00. Similarly for other pack sizes, the relevant Technical Directions (first versions) shall bear Packaging Formula Number as 201502S00-00, 201503S00-00 and so on, for sale of the product in the domestic market.

Documentation Cell (R&D) shall maintain the list of all Master Formula Cards.

Process Development Department shall maintain the list of all TDs detailing manufacturing procedure.

Packaging Development Department shall maintain the list of all TDs detailing packaging procedure.

Note:  Documentation cell R&D shall update list of Site location of Pharmaceutical products Whenever there is addition of new Location site and shall send a copy of same to QA for there reference.

Quality Assurance

SOP for Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS Items

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SOP for Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS Items

Objective : To lay down a procedure for Assigning of Identification Numbers to Equipments, Sub-Equipments and In-process SS items in various departments.

Scope : This Standard Operating Procedure is applicable to various departments of formulation plant.

Responsibility :

Head of departments or his / her designee shall be responsible for assigning ID. Nos. to equipments, sub-equipments and in-process SS items of their respective departments.

Head-Quality Assurance shall ensure the implementation and compliance of this SOP.

Abbreviations and Definitions

Sub-Equipment :  The sub equipments are the equipments installed on the main equipment meant for recording various process parameters during run of that equipment.

In-process SS Items : Any SS item which is supposed to be in direct contact with the product or its ingredients during dispensing, sampling or manufacturing operations.

Procedure

Note: The numbering of Sieves and Screens shall be done as per SOP titled “Control of Sieves and Screens of different equipment”, numbering of Change Parts of various equipments shall be done as per SOP titled “Control of Change Parts” and numbering of Dies and Punches shall be done as per “Control of Dies and Punches” .

Equipment Numbering: Equipments installed in various departments shall be assigned unique ID. No. as per the steps discussed below.

The first and second character shall be ‘EQ’ denoting equipment.

The third character shall be ‘/’ (slash).

The fourth and fifth character shall denote the department in which equipment is installed. The codes for each department shall be as follows:

PR       : Production

QC      : Quality Control

EN       : Engineering

AH      : Administration and Housekeeping

ST       : Stores (RM and PM)

WH     : Finished Goods Warehouse

The sixth character shall be ‘/’ (slash).

The seventh, eighth and ninth characters shall be the numerical digits for the serial number of equipment. The first number of the equipment shall be 001, 002, 003 and so on.

E.g. the complete ID. No. of equipment installed in Production department shall be EQ/PR/001 and Quality Control shall be EQ/QC/001 respectively.

All equipments with same make, design, function or use shall be given separate ID. No.

List of equipments installed at various departments shall be prepared by respective departments and shall be distributed to QA on need basis (whenever there is a change or installation of new equipment) or monthly; whichever is earlier.

Sub-Equipment Numbering: Sub-Equipments like vacuum gauges, pressure gauges, pumps, detectors, data loggers etc. installed on equipments in various departments shall be numbered as follows:

The sub equipment numbering shall consist of eleven (11) characters.

The first six characters of sub-equipment numbering shall be same as the last six characters of the Equipment ID. No. assigned to the main equipment on which the sub-equipment is to be installed.

The seventh character shall be a dash ‘-’.

The eighth and ninth character shall be two characters representing the type of sub-equipment like, VG for vacuum gauges, PG for pressure gauges, PU for pumps, DT for detectors, DL for data loggers etc.

The tenth and eleventh characters shall be numeric digits starting from 01 for the first item of the same type e.g. vacuum gauges installed on leak test equipment installed in production department heaving Equipment ID. No. EQ/PR/004 shall be numbered as PR/004-VG01.

Note: If different types (w.r.t. their application) of sub-equipments are having identical two principal characters derived from their nomenclature, then their numbering can be made distinct by taking one more character, hence making numbering of sub-equipment of twelve characters, e.g. DPT can be assigned to represent the differential pressure transmitter and DPS for differential pressure sensor.

List of sub-equipments installed on equipments in various departments shall be prepared by respective departments and shall be distributed to QA on need basis (whenever there is a change or installation of new equipment) or monthly; whichever is earlier.

Numbering for In-process SS Items: All in-process SS items with capacity more than 30 kg approximately like Storage Bins, mugs, spatulas, spoons, scrappers, buckets, sampling aids etc. shall be numbered as follows:

The in-process SS item numbering shall consist of five (05) characters.

All the contact items shall be numbered in a three digit (started as 001) serial no. with the prefix of ‘SB’ for storage bins, drums, vessels and buckets; ‘BB’ for blender bins; ‘MG’ for mugs and measuring cylinders; ‘SP’ for spatula/spoons/scrappers and ‘SA’ for sampling aids.

The three numeric characters (started as 001) shall be allotted as per following system:

001 to 099                                           Stores (RM and PM)

100 to 299                                           Production Block

300 to 399                                          Quality Control

400 to 499                                           Engineering

The allotment of each identification number to each in-process SS items shall be maintained in the register.

For SS items having capacity less than 30 kg approximately, set number shall be assigned as per SOP.

The identification number on each equipment, sub-equipment and in-process SS items shall be conspicuously written.

Quality Assurance

SOP for Control of Stamps in Quality Assurance Department

SOP for Control of Stamps in Quality Assurance Department

Objective : To lay down a procedure for Control of Stamps in Quality Assurance department.

Scope :  This standard operating procedure is applicable to formulation plant.

Responsibility :

Officer/Executive QA shall be responsible for implementation of procedure as per this SOP.

Head QA/ designee shall be responsible for compliance of this SOP.

Abbreviations and Definitions

Documents : Controlled Quality documents not limited to TDs, SOPs, Specifications & STPs/ GTPs, Protocols, etc.

Master Copy :  The original set of controlled documents or written procedures which shall be retained at Documentation Cell of Quality Assurance and carry the stamp ‘MASTER COPY’.

Controlled Copy :  The photocopy of the master copy of controlled documents (like SOPs,  STPs, GTPs etc.) or written procedures which shall be distributed to the user department(s) as a part of document distribution procedure and shall bear a stamp as ‘Controlled Copy No.­­­____’ and initials of the concerned personnel. These documents are controlled documents and are retrievable whenever superseded.

Uncontrolled Copy : The photocopy of master copy of controlled documents or written procedures which shall be given to any department or person for reference purpose only. These documents are not controlled documents; hence are non retrievable.

Procedure :

QA Personnel shall be responsible for control of stamps used in Quality Assurance department.

Order of stamps shall be send through e-mail, fax, written document to Administration department after approval of Head-QA.

Quantity of stamps received in QA shall be properly maintained with Stamp number on it.

All the stamps shall be numbered as 01, 02, 03 and so on as per the quantity available in department for e.g. if 3 Master copy  stamps are  available then numbering for all stamps shall be done like Master copy No-01, Master copy no-02 , Master copy no-03.

In case of any mistake in stamp, same shall be send back to supplier after putting remark for correction.

Colours and usage of stamps shall be finalized as per the respective SOPs.

The reference of Master copy, controlled copy, uncontrolled copy, obsolete copy, reference copy, review stamps shall be taken as per SOP.

Issuance stamp shall be put on each format issued to concerned department and on each BMR issued to Production department as per SOP.

All the stamps shall be properly marked with the Name and Number to avoid any kind of inconvenience and for easy traceability.

All the stamps shall be kept under lock and key by QA Personnel after day activities is over.

All the stamps shall be properly kept in separate small polybags as per there type i.e. Master, controlled etc. and kept in separate drawer under lock and key.

At a time one stamp of each type shall be used as per requirement for daily documentation or stamping purpose and it shall be properly put in separate polybag after use and kept  under lock and key to avoid any misuse of stamps.

Tentative reference of all stamps in QA department is mentioned.

QA Personnel shall counter check all the stamps received for any kind of mistake i.e. spelling mistake etc.

Stamps which can’t be used further shall be properly destroyed by QA Personnel by cutting rubber portion of stamp into small pieces to avoid any kind of misuse.

Issuance record of stamps shall be recorded and Stamps destruction record shall be recorded.

Quality Assurance

SOP for Preparation of Validation and Qualification protocols

SOP for Preparation of Validation and Qualification protocols

Objective : To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may affect the quality of products directly or indirectly.

Scope : This standard procedure is applicable at the QA department.

Responsibility :

Officer/Executive-QA/Store/Production/QC/Engineering shall be responsible for implementation of this SOP.

HOD/Designee-QA/Store/Production/QC/Engineering shall be responsible for compliance to the procedure as per this SOP.

Definitions :

 Manufacturing process : The transformation of starting materials into finished products through a single operation or a sequence of operations involving installations, personnel, documentation and environment.

Qualification: Identification of equipment attributes related to the performance of particular function or             functions and allocation of certain limits or restrictions to those attributes.

Equipment Qualification: The act of planning, carrying out and recording the results of tests on equipment to           confirm its capabilities and to demonstrate that it will perform as intended.

Design Qualification (DQ): Documented evidence that the systems or subsystems have been designed in accordance with the requirements of GMP.

Installation Qualification (IQ): The documented verification that the facilities, systems and equipment as installed or modified, comply with the approved design and manufacturer’s recommendations.

Operational Qualification (OQ): The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

Performance Qualification (PQ): Documented verification that the integrated system or subsystem functions as  intended, in its normal operating environment.

Validation: Establishing documented evidence that a system does what it purports to do.

Revalidation: Repetition of validation process or a specific portion of, to ensure continued compliance with established requirements.

Procedure

Equipment Qualification Protocol:

Note: Qualification protocols are prepared for those systems, utility, facility, equipments and area defined as critical for the process. They are prepared following a structure defined in the following sections.

URS: It shall be prepared by User department, checked by Engineering Department and approved by User department; Engineering and Quality Assurance department.

Equipment Name and its capacity shall be written in under the Description in header. Document number shall be given as per SOP.

Equipment no shall be assign by the user department as per their numbering sequences.

The equipment shall preciously describe the system and its intended purpose i.e. use and field of identification where this shall be located and its prescribed environmental condition and dimension of location in required specification column.

Glossary shall be attached as annexure which contain the abbreviation and components list and its specification.

In operational requirements column shall be written whatever the headings is applicable to the required equipment.

The cover page shall prepared as annexure and incorporate with URS.

(QA) shall keep the final copy of approved URS along with relevant drawings.

The duplicate copy of approved URS shall be forwarded to the vendor or supplier for intended purpose.

Any modification over the approved URS shall be documented with adequate supporting rationale and shall be in acceptance to the initial signatories of approval.

Design Qualification:

The vendor shall provide the design qualification document (including relevant drawing).

It shall be reviewed and approved by the validation team and shall be undertaken in conjunction with other relevant department(s) against the URS sent to vendor.

Copy of the approved document will be sent to vendor.

If not provided by vendor then by mutually understand the design and make the document as per the format of DQ is attached.

In format, wherever the Name of Equipment mentioned there shall be written exactly the Name of equipment and Document number as per SOP.

Installation Qualification :

IQ protocol and report shall be provided by the supplier or will be prepared by the validation team based on business terms and condition in Purchase order (PO).

IQ protocol and report shall be reviewed by Validation team and approved by the Quality Assurance Head.

The installation qualification protocol attached as Annexure-3 and report.

IQ Protocol and Report wherever the Name of equipment mentioned in Annexure it shall be written the exact name of the equipment.

In component result – under Description, the name of parameters to be verified shall be written Eg: Make Model and Sr.No etc.

Under specification- mentioning the information given by vendor in DQ, certificate and manual shall be written.

Verification Source- shall be written how the specification meets or not from the information which are available in certificate, manual, and in name plate.

Utility verification-shall be mentioned in vendor demanded utilities e.g. compressed air, electricity etc.

It shall be Systematic check of installed equipment against equipment’s supplier specification and/ or additional criteria identified and communicated in the purchase order (PQ).

Operational Qualification:

OQ protocol shall be provided by the supplier or will be prepared by the validation team based on business terms and condition in Purchase order (PO).

OQ protocol will be reviewed by Validation team and approved by the Quality Documentation Cell (QA) shall keep the final copy of approved OQ document along with relevant drawings.

The operational qualification protocol attached as annexure-5 and report.

IQ Protocol and Report wherever the Name of equipment mentioned it shall be written the exact name of the equipment.

In protocol shall be written the main operation parameter verification test procedure for controlled and operated by PLC or manual.

From the instruction given by operating manual or by the instruction provided by vendor representative the test and acceptance column shall be written.

It shall be Systematic check of installed equipment against equipment’s supplier operating specification and/ or additional criteria identified and communicated in the purchase order and DQ as a functional specification.

Performance Qualification:

PQ protocol shall be prepared by the validation team and approved by Head of Production, QC and Quality Assurance.

Documentation Cell (QA) shall keep the final copy of approved PQ document along with relevant drawings.

The performance qualification protocol and cover page attached.

Validation Report cover page, Index page for Validation Report, Approval Sheet, Name of validation team members, Parameter recording sheet, Deviations and Investigations, if any, Qualification Reports and Certification of completion of validation shall be the content of PQ report shall be attached.

Above said documents shall be mentioned in Protocol as a separate Annexures.

Annexure of Parameter Recording Sheet in report shall be written the Selected Product, Batch Number, Batch size, MFC Number, Date of Manufacturing, Critical parameters which directly impact on the quality of the product.

Document number mentioned in References, shall be the respective doc number of

Computer Hardware and Software (DQ/IQ/OQ/PQ) qualification:

Computer hardware and software used as part of the equipment and systems to control equipment or system must be validated. Design, Installation, Operational qualification of hardware and software should be executed prior to Performance qualification of the associated equipment or system.

For reasons of expediency, computer validation can be executed as part of the systems or equipment validation. It shall be done by external party and they will provide the necessary documents of validation systems.

Process Validation/ Qualification Documents:

Process Validation Protocol format attached a Cover Page.

Results of the validation study shall be documented in a validation report attached.

The header of Protocol and Report Product Name (Generic name or Brand name should be mentioned.

The protocol Number shall be mentioned as per SOP.

Batch Size shall be mentioned either in Numbers or in Kg & Numbers as per technical direction of the Product.

Master formula Number is taken from technical direction of the particular product.

The Validation Report shall contain the following components which are incorporated in protocol as an annexures and the annexures shall be written.

Validation team members-shall be written the name of the members from different department will be involved in the validation activity.

Equipment list shall be written the name and it’s ID of all the equipments and instruments used from dispensing to final packing process including the Instruments  which are used in Process controls.

Approved raw material list should have the name of all API’s, Excipients and their vendor name & in house item codes.

Process flow chart-it shall be interlinked between Equipment type and sizes, process step and process variables as a flow chart.

Critical process variables-Stages of process with respective equipment and its variables shall be written in observation column.

Sampling plan and analytical data compilation &acceptance Criteria-It shall be contained stage sampling plan location of sampling (diagram of location), frequency of sampling, quantity of sample, analysis plan shall be written the parameter to be tested as per respective STP number to be filled. Under record the analytical findings the equipment used for testing and its calibration status sampling interval individual sample and their test result checked by name/ sign of person and date while compiling the data shall be the test parameters and results shall be compared with their acceptance criteria.

Environmental monitoring record (holding studies)

Process validation report cover page-the name of the product of Export, generic name and their strength shall be mentioned if its for domestic market then the brand name with active material and their strength shall be mentioned.

Process validation report approval sheet shall be filled.

Process validation Report shall be prepared by the cumulative of all stages and all batch numbers.

Summarize the findings and observations of the validation studies with conclusion of process capability.

Statistics can be made to interpret data obtained and provide meaningful information during validation exercise.

Point No 6.1 and 6.2 of annexure- 9 shall be extended as per equipment usage and in-process steps shall be written the current Specs No and STP no. for the respective product.

Manufacturing procedure shall be written as per technical direction briefly without skipping or missing any steps shall be extended as process requirement and the sequences of Process step to be mentioned under process step and the critical process parameter which are identified earlier shall mentioned under the process parameter and justifies the   process step consideration by what parameters &how those parameters are justified by the test parameters and sampling methods, location of sampling and quantity of samples.

Process steps and sampling analysis plan and acceptance shall be written for all steps.

Holding studies shall be clearly mentioned the Quantity of material to be kept under these studies, Frequency of sampling, test parameter, packaging type, and area of storage, test method and acceptance criteria of test method.

Process validation/ Qualification program (plan and number of batches to be monitored) should be a part of Validation Master Plan (VMP).

Cleaning Validation:

Title: shall be written as ‘Cleaning validation protocol for the area (applicable area name to be mentioned e.g. Main production block, soft gel block, etc.) and the dosage forms eg. Tablet & Capsule section.

Document number shall be written as per SOP.

Heading of Objective: it shall be written as  the procedure being followed for cleaning of equipment and accessories is effective and remove all residues of previous batch, cleaning agent and holding of equipment in dirty and cleaned conditions to a pre-determined acceptance level thereby avoiding the risk of cross contamination and no microbial proliferation in equipments.

Scope: it shall be written specifically area of consideration for the study with highlighting the major concerns of this activity.

Responsibility: shall be written clear and specific activity and their role of every department.

shall be written the Dosage forms eg. Tablet & Capsule and Area Eg. Main Production Block.

Prepare the Product matrix and mentioned the Number of the prepared annexure shall be mentioned here.

Prepare the Equipment matrix Annexure and mentioned the number of the prepared annexure I here.

Prepare the Pre-Cleaning Validation requirements and mentioned the respective number of an annexure.

Prepare for the chemical rinse/swab test report for every product  as the Annexure ,for micro prepare and for SLS prepare an annexure and for hold time report prepare an annexure and  for total carry over prepare an annexure  and mentioned the Number of annexure where Applicable.

Prepare the Sampling plan as an annexure and mentioned the annexure number and prepare the sample location as annexure and mentioned the annexure number where Applicable.

Test record for the equipments used in the product manufacturing shall be prepared.

Test Procedure shall be prepared for the drug which are considered for validation and put here as an annexure.

Summarize the findings and observations of the validation studies with conclusion in annexure and the annexure shall be prepared.

After completion of validation, the report shall be included the certificate of application.

Mapping of the Environmental Conditions

The header of Protocol the Title shall be written and the area of the mapping to be address with the title Eg: Mapping of the Environmental Conditions (Temperature and Relative Humidity) in Ware House Area.

Protocol number shall be written as per SOP.

Protocol approval sheet under the heading of Functional Area, the persons who are responsible for the activity to be done Eg. Warehouse.

Objective shall be mentioned as per specific condition to be validated Eg. Temperature and Relative humidity or only temperature or only Relative humidity with the area.

Scope shall be mentioned specific condition to be validated, area of validation and duration of validation.

shall be written the condition to be validated, no of days the reading to be taken, frequency of reading..

The following components shall be prepared and mention as an annexure wherever it is applicable in protocol and all these are incorporated protocol and it can be numbered as per requirement.

  • Validation Team Members
  • Equipment/ Instrument List
  • Design Conditions and Acceptance Criteria
  • Locations for Monitoring
  • Cover page of the Report
  • Validation Report Approval Sheet
  • Validation Report Summary Conclusion
  • Deviation form
  • Temperature and RH Recording Sheet

Report shall be prepared by end of activity in every quarter and final report shall be prepared at end of the year and every report contains the following components and these are already in protoco.

Report number shall be given as per SOP.

  • Cover page
  • Report approval sheet
  • Summary and conclusion
  • Deviation and investigation

Shipping Validation

Protocol number shall be written as per SOP

Objective shall be mentioned the specific condition to be validated with the final destination. e.g. both temperature and %RH or Temperature only.

Scope shall be mentioned specific condition to be validated, frequency of validation.

The following components shall be prepared and mention as annexure wherever it is applicable in Protocol and all these are incorporated protocol and it can be numbered as per requirement.

  • Arrangement of Data Loggers
  • Details of Shipping Validation Study
  • Cover page of the Report
  • Validation Report Approval Sheet
  • Validation Report Summary & Conclusion.

Validation report number shall be as per SOP.

Report shall be prepared end of activity in every quarter and final report shall be end of the year and every report contains the following components and these are already in protocol.

  • Cover page
  • Details of Shipping Validation Study
  • Summary and conclusion
Quality Assurance

SOP for Access control system numbering and usage

SOP for Access control system numbering and usage

Objective : To lay down a procedure for assigning of identification numbers to access control system and usage of the system.

Scope : This Standard Operating Procedure is applicable to various departments of formulation plant.

Responsibility :

Head-User department shall be responsible for sending the request to QA department for authorization of the different personnel’s for entering in their respective areas.

Head-QA/Designee shall be responsible for approving the request as per this SOP.

Head-HRD/Designee to record all authorization given to concerned.

Head-Engineering/Designee shall be responsible for assigning numbers to assess control systems.

Head-IT/Designee shall be responsible for the technical support of the access control to HRD.

Head-Concerned department/designee shall be responsible for receiving the visitors (arriving for particular department job) and there movement within the premise.

Head-QA/designee shall be responsible for receiving the auditors and there visit inside the plant and providing the access cards (if required).

Head-Quality Assurance shall ensure the implementation and compliance of this SOP.

All users to follow the entry/exit procedure as per this SOP.

Abbreviations and Definitions

Access Control System :An access control system determines who is allowed to enter or exit, where they are allowed to exit or enter, and when they are allowed to enter or exit.

Request for Permit :

Head-User department/Designee shall send the request to QA for giving the permit to enter in the respective area.

Head-QA/Designee shall review the request and forward the copy of the same to Head-HRD/Designee.

Head-HRD/Designee shall forward the request (after approving) to Head-IT/Designee for technical support.

Head-IT/Designee shall provide the access to concerned personnel’s in their respective working area as per the approved request.

Records of the same shall be kept by HR department.

Access shall be provided to all users on their punch cards.

In case of personnel visiting the plant from other location for some official work, Head-HRD/designee shall provide the access cards to those personnel with restricted area entry depending upon the classification of work and the area in which there work is allotted.

In case of personnel those are not on company payroll/ contractual basis and are working on the production shop floor or any other location where access is required, access card shall be provided to those personnel by security personnel at the time of entry in the premise and the same shall be deposited back at the same place while exit from company premise.

Security personnel shall give the access card to the personnel, while taking his/her signatures in the entry register along with the access card number (with restricted entry).

Note: – Department Heads of all the concerned departments shall have master card having access to all areas.

Entry/Exit Procedure

While entering or exit form the area, personnel’s have to show their access/punch cards in front of the sensor, until acceptance for the same has been accounted.

If the person has the access, he can open the doors and if the person does not have the access he cannot open the doors.

Numbering System for Access Control System

Each access control unit is divided into two categories

Controller and Locks, each controller unit comprise of four locks.

Number procedure of Controllers, Controller numbers shall start with C01, C02, C03, C04 and so on.

Lock numbers shall be assigned with unique characters.

Lock numbers shall consist of alpha-numeric characters as “XYY”.

“X” denotes respective area.

“YY” representing the numbering e.g. 01, 02, 03 and so on.

Precautions during usage of access control cards

In case of any exigency, break the glass of emergency exit release and press—*—.

Do not forcefully try to open the door if you are not authorized to enter in that particular area.

Do not touch the sensor of the access control system with hand or with any other metallic items.

In case of lost/discrepancies in the card immediately inform Department-Head about the same in order to discontinue the authorization in the respective area.

Head-Concerned department/designee shall intimate the same to Head-HRD/Designee for further processing.

All records related to permit of the personnel’s shall be retained by HRD.

New joinees shall be given the master card (having restricted entry to particular areas) on permission of respective HOD, until they got their personal access card.

In case of any type of exigency, Head-IT/designee shall discontinue the access control system so that each individual shall depart from that particular area, also in case if some technical fault arose in the system individual should break the doors with the usage of hammer (provided at critical junctures).

Area wise distribution of controllers and lock.

Note:   This is a makeshift arrangement and shall be pertinent for only three month, after three months a complete investigational report shall be prepared by Head-HRD/designee in order to verify the applicability of the system and after the review of verification report SOP shall be revised.

Verification report is based upon the individual movement in a particular area and its tracking within the software.