SOP ON INDUCTION OF NEW EMPLOYEES

OBJECTIVE: To lay down a procedure is to acquaint newcomer with all the system and procedure of the Company.

SCOPE: This Procedure is applicable to all recruits.

RESPONSIBILITY: Officer / Executive – P&A

ACCOUNTABILITY:

Manager –P&A

Head QA-Compliance Of this SOP

PROCEDURE:

Arrange induction training to a new recruit (except unskilled workers) in each department.

On first day of joining, Manager Personnel & Administration or designee informs new joiner about the Company Policy and Rules.

Manager Personnel & Administration or designee issues him induction schedule as per SOP, SOP Titled “Training Procedure for plant Personnel”, mentioning name of the department, date and duration for which the new joiner has to undergo induction program.

Manager Personnel & Administration or designee introduces the person with respective department heads.

The person contacts the concerned department head in which he has to undergo induction training.

The new comer learns about process, people, practices, rules and other norms of the different departments for minimum one hour during the course of induction.

After induction in a department he takes the signatures of concerned department Head / Nominee in the induction schedule.

After completion of induction in all the departments the employee submits format to the Personnel & Administration department about the completion of the induction program.

In case of unskilled workers, Manager Personnel & Administration or designee briefs him about company policies/ rules and regulations, general hygiene requirements and important aspects for working in pharmaceutical industry, and disciplinary norms to be observed.

Manager Personnel & Administration or designee introduces him to the concerned department head and other associate departments. The concerned department head provides him necessary on the job training.

SOP ON BUILDING CLEANING

OBJECTIVE: To lay down the procedure for cleaning of building premises.

SCOPE: This SOP is applicable for cleaning of entire Premises (Production, QA, Administration office, Utility, Security, Panel room, Change rooms, Toilets, Stairs, and Corridors, and outside areas including roads and garden).

RESPONSIBILITY:

House Keeping Supervisor

Officer / Executive – Personnel & Administration

ACCOUNTABILITY:

Head–Personnel & Administration

HOD QA-Compliance of this SOP

PROCEDURE:

Mopping- To remove liquid from something using a dry cloth.

Brooming- A cleaning implement for sweeping.

Cleaning Tools;

Mops, Brush, Wiper, Wall cleaner, Glass wiper, Glass cleaner and Vacuum Cleaner.

Use double bucket system for cleaning of area.

Cleaning shall be performed as per procedure given below:

Use the house keeping aids such as normal brooms, nylon brooms, floor and wall wipers, moping cloth for floor cleaning.

Use Colin for glass cleaning.

Use Teepol solution or Harpic for wash basins and toilets.

Use cloth dusters for dry cleaning of door frames, window panes, light fixtures, walls, partitions, sealing.

Use 2.5% Savlon, 2.5% Lysol, and 2.5% Dettol as disinfectant.

Carry out the cleaning and sanitation activities of production and warehouse as per the frequencies  like daily, weekly and fortnightly with proper concentration as per prescribed by QA  SOP  Titled with  ‘Procedure for general cleaning warehouse and production’.

The daily cleaning activities shall be done in all the above mentioned areas are as follows:

Floor cleaning:

Sweep the floor of manufacturing or related area with nylon broom in such a manner that dust contamination in the surroundings is minimum.

Mop the floor thoroughly with a moping cloth soaked in solution of disinfectant in Water.

Mop the gallery area and packing halls using 2.5 % solution of floor cleaner.

Perform floor cleaning as per the requirement but at least two times a day.

Glass panes and mirrors:

Clean the glass panes and mirrors using clean dry cloth.

Spray the glass cleaning agents on glass panes.

Clean the window with clean cloth.

Glass pane cleaning has to be done as and when required but at least twice in a day.

Door & window frames:

De-dust with clean cloth.

Clean the door and window frames with wet cloth soaked in water.

Finally clean them with dry cloth.

Clean the doors and window frames twice in a day.

Light Fixtures:

Only outside cleaning of light fixtures has to be done by housekeeping personnel.

Switch off the light that has to be cleaned.

Clean the light fixture softly with dry cloth.

The light fixtures have to be cleaned once in fifteen days.

If inside cleaning of glass fixtures is required the same has to be communicated to manager engineering. Manager engineering deputes an electrician for doing the same.

Drains Points:

Clean the drain points fortnightly.

Open the coverage of drain points.

Clean the drains with water and brush if required.

Check for any type of insects, cockroaches inside the drain point if found inform the pest control person immediately.

Wash the drain points using phenyl solution or disinfectant solution.

Maintain the record of all activities in General Cleaning Record.

Toilets:

Use the house keeping aids such as toilet brush, wipers, moping cloth for floor cleaning.

Use Harpic, Acid, Teepol for cleaning of basins, sinks, pots and urinals.

Use Phenyl, Dettol and Savlon as disinfectant.

Use Odonil and naphthalene balls as air freshener.

Carry out the cleaning and sanitation activities of toilets as per the requirement but at least twice a day.

Clean the basins, urinals and pots with water.

Apply the Harpic, teepol or acid as per the requirement to the basin, urinal or pots of toilet and keep the same applied for two to three minutes.

Apply the toilet brush or scrubber.

Pour plenty of water and clean the surface.

Put naphthalene balls in the urinals.

Check and replace the air fresheners if required.

Carry out the cleaning activities as and when required but at least twice a day.

Record all the activities in Toilet Cleaning Record.

SOP ON PROCEDURE FOR RAW MATERIAL TRANSFER FROM ONE MANUFACTURING SITE TO ANOTHER SITE

OBJECTIVE: To lay down the procedure for Raw material transfer from One manufacturing Site to another site.

SCOPE:  This procedure is applicable to Raw material transfer from quarantine of warehouse.

RESPONSIBILITY:

It is the responsibility of warehouse other also assistant to follow the procedure as prescribed in this SOP.

In-charge, Warehouse or designee is responsible for execution of SOP and maintaining the records.

Manager/Executive or designee of Administration department is responsible for giving the training on related tasks.

ACCOUNTABILITY: Head of the P&A Department.

PROCEDURE:

Authorized person from Head of department of Administration shall inform to Warehouse person for dispatch of raw materials. Warehouse department shall enter vendor batch detail in ERP. And give the intimation in the form of Goods Transfer Note. Through ERP software.

Account Department shall prepare draft copy of challan/invoice on paper and same shall checked by warehouse person

Warehouse person ensure that transfer of raw material Invoice Note is approved from authorize person.

After checking Draft copy of invoice and find the all Details are correct than final copy of Challan/Invoice shall be taken on two copies printed and duly signed by Warehouse person.

Warehouse person will physically verify the invoice details.

The delivery instruction shall be written on invoice and inform to Transport Picking up the goods from the factory premises.

After the satisfactory confirmation warehouse person verify the condition of vehicle with any respect to cleanness of vehicle to avoid possible contamination after satisfactory verification allow loading of materials.

Warehouse person shall check the following parameter physically before transferring the raw material.

Quantity /product Detail

Details on original container label

Quantity in loose box

Warehouse person clean the outer surface of container with lint free cloth.

During the loading Warehouse person check the condition of each and every packet for damage vendor seal, leakage, spillage, dent, broken lid, material, identification label. (Batch No., Mfg. Date, Exp. Date), Quarantine label.

Before loading Warehouse person count the number of container, Bags, Packets and after satisfactory verification. Take a gross weight of each container of raw materials and note gross weight on weight checking sheet.

Warehouse person sign on invoice or also prepare and sign the Gate Pass for loaded vehicle outward from factory premises.

Security officer make the entry in outward register with respect their invoice no. and allow to vehicle for outward from factory premises

SOP ON DRESS WASHING, ISSUE & CONTROL

OBJECTIVE: To lay down a procedure for dress code numbering, washing, issue & control.

SCOPE: This Procedure is applicable for cleaning of general dress of employees working.

RESPONSIBILITY: Housekeeping Supervisor/ Nominee

ACCOUNTABILITY: Manager – P&A

PROCEDURE:

Monitoring of Garments Washing:

Pre-start-up:

Visually check the cleanliness of garment wash room.

Check the status of the machine for its operation.

Clean the Garment washing machine before carrying out the washing of garments as per SOP.

Wash the controlled area and critical area garments separately.

Wash the booties of garments separately.

Visually check that there are no cloths inside the machine of previous cycle.

Before proceed to cleaning operation check that detergent quantity is sufficient to clean.

Any noted brand of detergent currently running in the market e.g. Ghari, Fena etc. shall be used for cleaning.

Start-up:

Operation of the Garment Washing:

Insert the plug in switch board.

Press the ON /OFF button.

After pressing of ON/OFF button machine is ready, load the garment.

Press the door open button.

The door open led will be on and the door is ready to open.

Open the door.

Place the garments uniformly into the machine according to the recommended load capacity.

Place the little clothing materials inside the pillow cases to avoid them slip into the pump and filter.

Make sure that there is no clothing at the side of the door.

Close the front door by pushing it lightly. If the door does not close completely, the machine could not be started.

Front door is locked until washing cycle is complete and it will take two minutes to open after completion of washing cycle.

Front door can be opened only when the machine is off.

Open the tap and use purified water filtered through 1 micron filter for washing of garments.

Place the machine drain hose pipe in main drain of garment washing room.

Fill the detergent in the respective compartment provided on the top of machine.

Close the detergent dispenser box.

Select the program according to dirt strength.

When the desired program is selected, related spin speed can be adjusted for garments washing and drying according to requirement.

Push the start button to operate the machine.

Take the washing cycle according selected program.

Machine stops automatically when the entire program is finished.

Turn off the tap.

In one or two minutes when the door open led lights up ,press the door open button and open the door.

Press the on/off button to switch off the machine.

Unload the machine and leave the front door open.

Check the door hood for any traces of water; if water left in the door hood remove it by soft cotton.

Place the washed and dried garments on the S.S. perforated table under Laminar Air Flow

Shut Down:

After completion of the operation Switch “OFF” the machine.

Switch “OFF” the main electric supply.

Clean the machine as per SOP and get cleaning checked by production officer.

Record the operation, cleaning & maintenance details in the equipment log book as per SOP and get checked by production officer.

Inspection of Garments:

Firstly check the garments visually for cleanliness that is any stains.

If the garments are not found visually clean repeat the cleaning procedure.

The washing area supervisor/officer should check the washed garments for following defects like defective Zip, unclean garments, torn clothing, torn velcroes or any fiber shedding ends.

Reject the defective garments. The washing area supervisor/officer to take the decision for re-washing/ repair/ disposal of the rejected garments based on the defect.

In case of torn velcroes, defective zip and miner tear of the garments send the garments for repair duly covered in a poly bag and record of the same to be maintained in the prescribed format.

Iron the inspected garments under table mounted Laminar Air Flow Unit.

Pack each set of garment with booties in lint free garment bags under LAF for sterilization.

The washing area supervisor / officer to maintain the record of the controlled/critical area garments as per the specimen format attached.

GENERAL GOWNING WASHING PROCEDURE

All the uniforms of plant personnel are as follows.

Fresh uniforms are issued twice in a week on Monday and Thursday and used dresses are to be sent for washing on Wednesday & Saturday after processing. All the Employees shall hand over their used dress to Housekeeping Supervisor/ nominated person for washing purpose.

WASHING PROCEDURE FOR MICRO UNIFORM (USING MICROBIOLOGY LAB.)

The Housekeeping Supervisor/ nominated person will prepare the washing solution by adding two spoons of detergent in a bucket of water.

Wash the dresses for 15 minutes in washing tub of the washing machine.

After washing, dry the dresses in the drier of the washing machine for 5 minutes.

After necessary checkup, the Housekeeping Supervisor/ nominated person will iron the dresses and bring them to the linen room in the polybag.

Before use Uniform in Micro lab has been sterilization in Autoclave. After Sterilization use in Uniform in Microbial Lab.

SOP ON PROCEDURE FOR MEDICAL EXAMINATION

OBJECTIVE: To lay down the procedure for Medical Examination of all employees.

SCOPE: This procedure is applicable for Medical Examination of all employees working.

RESPONSIBILITY: Officer/ Manager – Personnel & Administration.

ACCOUNTABILITY: Head QA – To ensure implementation of SOP.

PROCEDURE:

Qualified Physician– A person having medical degree and government registered practitioner. 

Medical Examination and Report Review:

All employees should be examined by a qualified physician.

All personnel shall undergo medical check-up prior to employment. The medical check-up shall be for fitment check-up for the job, which includes eye examination, colour blindness, tuberculosis, skin and other communicable contagious diseases.

In case a person found unfit for the job or affected by any contagious disease, he/she shall not be recruited.

The medical check-up shall be done for staff/workers once a year. Record shall be maintained by HR department.

After the medical check-up, the doctor shall certify about the fitness of the employee.

In case a person found affected by any contagious disease during the yearly medical check-up, he/she shall not be allowed to work and shall be advised for future necessary treatment.

After completion of the treatment the employee shall be allowed to resume his/her original place of employment after obtaining medical fitness certificate by a qualified physician.

HR department shall maintain required records or certification by the physician.

Lockers:

No clothing issued from linen to be stored in lockers.

Each employee is provided with a locker which must be kept clean and free of dust.

Dirty protective clothing, dirty or rusty equipment and food scraps and other rubbish must not be stored in lockers.

Personal or street clothes and company issue protective clothing must not be stored together. Footwear must be placed on the bottom of the locker or opposite of entry to manufacturing and packaging area and must not contact any other item.

Personnel Access:

Employees must not move from a restricted or dirty area to a clean area without first changing into clean outer protective clothing and footwear and thoroughly washing hands with IPA. This also applies to visitors and personnel.

Maintenance staff and personnel must not enter production areas without gowning and hair covering.

Visitors must be suitability attired for the area which they wish to visit.

SOP ON OPERATION AND CLEANING OF INSECTICUTER

OBJECTIVE : To lay down the procedure for operation and Cleaning of Insecticuter.

SCOPE : This SOP is applicable for the operation and Cleaning of Insecticuter mounted for the protection of ancillary area with insects in the plant.

RESPONSIBILITY: Officer/ Manager- Personnel & Administration – To ensure proper cleaning and operation of Insecicuter.

ACCOUNTABILITY: To ensure implementation of procedure

PROCEDURE:

Put “OFF” main switch of Insecticuter.

Remove the power plug of Insecticuter.

Remove the tray from the bottom side of Insecticuter.

Count the insects put into a polythene bag, properly label and sent for destruction.

Clean the unit and tray by a dry cloth.

If any stain is observed, clean with 70 % IPA.

After completion of cleaning fix the tray back in place.

Check the tube rod for cleaning if any visible dust is found, clean with dry cloth carefully.

If tube rods are not working, inform Engineering department for replacement.

Make the electrical connection by putting connecting wire in the socket and switch on the the

The number of dead insect should not be more than 20 in Routine session and should not be more than 30 in monsoon

If the dead insect found more than acceptance then the frequency on pest control shall be increase.

Keep the Insecticuter always on except of time of cleaning. 

Frequency:

For cleaning of Insecticuter is weekly.

For replacement of ultraviolet tube rod is once in six month

PROCEDURE FOR CLOTHING & PERSONAL HYGIENE

OBJECTIVE: To lay down the procedure for clothing and personal hygiene.

SCOPE: This procedure is applicable for clothing and personal hygiene.

RESPONSIBILITY: Officer/ Manager – Personnel & Administration.

ACCOUNTABILITY: Head QA – To ensure implementation of SOP.

PROCEDURE:

Personal Hygiene:

Clean outer protective clothing must be worn in all processing areas.

All personal / street clothing must be fully covered in ancillary area.

A clean set of company issue clothing must be collected each day from the linen.

Clothing must be change daily or whenever required.

Used clothing must be placed in the bin provided.

Company issue protective clothing must not be worn off the establishment.

Sitting is only permitted on the seat provided. Sitting on the any other structure is prohibited, to prevent contamination of clothing.

Footwear must be cleaned whenever entering or leaving the production area.

All hair must be fully covered at all times when in production areas.

This will require wearing a medical and if necessary a beard snood.

Lockers:

No clothing issued from linen to be stored in lockers.

Each employee is provided with a locker which must be kept clean and free of dust.

Dirty protective clothing , dirty or rusty equipment and food scraps and other rubbish must not be stored in lockers.

Personal or street clothes and company issue protective clothing must not be stored together. Footwear must be placed on the bottom of the locker or opposite of entry to manufacturing and packaging area and must not contact any other item.

Personnel Access:

Employees must not move from an restricted or dirty area to a clean area without first changing into clean outer protective clothing and footwear and thoroughly washing hands with IPA. This also applies to visitors and personnel.

Maintenance staff and personnel must not enter production areas without gowning and hair covering.

Visitors must be suitability attired for the area which they wish to visit.

SOP ON ENTRY & EXIT OF PERSONNEL IN THE FACTORY PREMISES

OBJECTIVE: To lay down a procedure for Entry & Exit of personnel in the factory premises.

SCOPE: This SOP is applicable for Entry & Exit of personnel in the factory premises..

RESPONSIBILITY: Head of the Department – Personnel and Administration.

PROCEDURE:

Permanent Employees Posted at Plant:

Employees shall enter the premises  with proper identification after biometric (Finger) punching.

Employees shall strictly adhere to timings as allotted to entry/exit.

Respective department head shall inform any change in individual’s duty timings to main gate in advance.

Workers arriving late for duty shall not be permitted to enter the premises.

Staff/workers leaving the premises before schedule timings shall bring the exit pass from their department heads and deposit at main gate. The same shall be submitted to plant personnel on the next day after endorsing out time.

All executives leaving the premises before scheduled time shall enter their particulars in “Officers Out/In Register” with time and reasons.

Time IN/Out in respect of officer / executives shall be recorded by security staff at main gate.

Permanent Employees Posted at Other Units :

Employees from other units visiting plant shall endorse their particulars in Unit with Employee  while entering/leaving the premises.

Contract Employees:

Contractor shall  maintain identity records of his all employees

Contract employees shall be accompanied with their supervisor at the time of their entry.

Contractor/Representative of Contractor shall remain present at main gate at the time of shift change.

He shall identify and detail his men power for various departments as per day’s requirement.

He shall then inform his strength of particular shift to security in charge at main gate.

No late entry shall be permitted to contract workers.

However, early exit may be permitted with valid exit pass signed by respective HODs and countersigned by HR Person.

Contractor representative shall be available in company premises all the time to sort out disputes of his employees.

Other Visitors:

All visitors visiting Unit  shall be received showing full courtesy and ask to whom he/she wants to visit.

Visitor’s identification shall be confirmed.

Visitors coming to meet personnel of Production or other areas shall not approach    directly to the individual but wait at reception/ office.

Individual concerned shall come to reception area and meet the visitor.

Visitors on return shall be requested to deposit the visitors pass at main gate issued to him/her.

Security guard at main gate shall ensure the person whom the visitor met have signed that pass.

Out time on the pass shall be endorsed by the security guard and this shall be filed accordingly.

Representatives of various courier services shall be asked to enter their name and time in the register maintained at main gate and allowed to go to postal department to hand over mail.

Service Engineers visiting Unit to attend AMC of computers, Air Conditioners or any machinery equipment instrument shall be treated as visitors for general business .

Their belongings/tool bag etc. shall be checked and list of items to be taken in shall be prepared at gate.

The same shall be rechecked where they leave the premises after the day’s business.

Students from various institutions coming for project work/educational tour shall be requested to enter their names in the register with incoming/out going timings.  They shall also be asked to declare their belonging and it will be re-checked while they leave the premises.

Prohibition of Photography:

Photography in the premises is strictly prohibited Photographic materials like, camera, films & other photographic materials if brought shall be deposited at the main gate.

In case, photography or videography is required in the premises or in side the departments for reasons like, training, validation work or product promotion or any other justified reasons, the permission from plant manager shall be seeked for this purpose.

SOP ON PEST AND RODENT CONTROL

OBJECTIVE: To lay down a procedure for pest & rodent control with a view to maintain hygiene and sanitation in the factory premises.

SCOPE: This SOP is applicable for pest & rodent control of following Mosquitoes, Cockroaches, Bugs, Ants, Silverfish, Rat and Lizards.

RESPONSIBILITY:

Officer – P&A & Administration

GM Technical Operation & Head -QA

ACCOUNTABILITY:

Head of the P&A Manager

PROCEDURE:

Name and address of the contractor: M/s Pest Control Services

Contract :

There shall be a written contract between firm and external agency address mentioned above.

Contract shall include the following :

Type of services, frequency, areas covered, pesticides used with their concentration, feed in Rodent traps, Disposal of dead or live Rodent, pest control service details, first  aid & antidotes for insecticides used for pest control.

Contract shall be renewed annually and shall be available with Plant Head /QA Head.

Rodent Control:

As per the contract the area / points where rodent control is to be carried out shall be earmarked as following:

On floor indicates point where rodent traps shall be placed.

Similarly on floor inside the entry points of the main building where gum pads shall be placed for rodent control.

HR personnel shall check all the rodent trap points for any Rodent trapped in the Trap on daily basis and record the activity.

If any rodent is found in the Trap / gum pad, the concerned HR person shall inform to the contractor for the disposal of the rodent.

Contractor shall also arrange the feed of the trap after disposal of the Trapped Rodent.

Disinfect 2 to 3 foot area around the trap / gum pad with 70% IPA.

If no rodent is trapped in the Trap; feed of the trap shall be replaced by contractor after every 15 days.

Plant manager and Head QA shall verify the activity once in a month.

Pest Control:

Pest control shall be carried out at the specified areas in the premises.

It shall not be carried out at RM storage, PM storage. FG storage area and production and packaging areas.

If shall be ensured that after pesticide spraying, the area shall be closed for 8-12 hrs, wherever feasible.

Drains / Manholes should be properly sprayed with pesticides to prevent entry of cockroaches and other pest from drain points.

Frequency – Twice in a month

Note: In case of rainy season the frequency of pest control shall be every 10 days.

Precautions:

The pest control /rodent control shall be performed by person of external agency along with our authorized person.

Intimation shall be circulated to all the department heads intimating them for pest and rodent control operations to be carried out.

Following precautions shall be taken while carrying out pest and rodent control:

Use of hand gloves and face mask.

Air handling system shall be switched off where pest control is being carried out.

The material in bags / drums etc. shall be closed with appropriate covers like polybags and lids in case of drums.

The devices used for carrying out pest and rodent control shall be dedicated and shall not be stored in factory premises.

The containers / bottles containing insecticides and pesticides and devices used for spraying etc. shall be taken back by the external agency after the treatment.

Before start of routine activities, ensure that the area is properly cleaned.

The employees of the contractor shall use appropriate equipments and clothing while performing pest / rodent control.

After carrying out pest control the concerned supervisor / HOD shall be responsible for evaluation of his concerned area for presence of any dead or alive insects, pest, etc. and observation shall be recorded in the format.

Similarly the contractor also shall provide certificate for completion of activity as per Annexure V.

Both the reports shall be reviewed and authorized by QA.

In case of any observation for live pest & rodent, the same shall be immediately reported to the contractor for taking immediate corrective action and additional pest / rodent control shall be performed.

All necessary Antidotes shall be available in case of any emergency for treatment of poisoning due to pesticides as recommended by contractor.

In case of observation of dead pest or rodent, it shall be carefully enclosed in a polybag and disposed off either by burying in ground or by incinerating outside the factory premises.