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SOP on Line Clearances

SOP on Line Clearances

  •  OBJECTIVE :To ensure that the area and equipment, required for the manufacturing and packing activities of pharmaceutical products are free from any potential sources of cross contamination/ mix-ups.
  • SCOPE:The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.
  • Responsibility: Officer/ Executive of respective department and IPQA shall be responsible to follow the procedure mentioned in this SOP.
  • ACCOUNTABILITY: Department Head and Quality Assurance Head shall be accountable for compliance of this SOP
  • Abbreviations and Definitions
  • IPQA: in – process quality Assurance

Metformin Hydrochloride Tablet 500 mg (drugsformulations.com)

  • PROCEDURE
    • Cleaned the equipment and area as per respective SOP.
    • Affix ‘CLEANED’ label on each cleaned equipment.
    • Fill the area status board.
    • Before starting any further activity verify the checkpoints mentioned in the annexure no. 01, for giving line clearance by respective department and IPQA.
    • If any discrepancy is observed repeat the previous step.
    • Write the details of previous product and next product [Name & Batch No.] at each different area.
    • Line Clearance Manufacturing Area:
    • During the line clearance of any Manufacturing Area following points shall be covered to check and verify in annexure no. 01.
    • Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
    • Mentioned the Room ID No.
    • Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
    • Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment. [All equipment shall be clean]
    • Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
    • Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment and area surrounding the balances.
    • If all above mentioned points are found satisfactory, respective department shall sign ‘CLEANED’ label.
    • IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
    • If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
    • Line Clearance RLAF:
    • During the line clearance of any RLAF following points shall be covered to check and verify in annexure no. 01.
    • Mentioned the Room ID No.
    • Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
    • Ensure updation of status board/status label.
    • Differential Pressure across pre-filters and HEPA filters are must be within limits.
    • Ensure cleanliness of Area, Cleanliness of Balances, Calibration of Balances, Cleanliness of Supply Air Grills of RLAF unit, Cleanliness of Return Air Grills of RLAF unit, Status label on IPC/bin/ balances/dispensing tools.
    • If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
    • IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
    • If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
    • Line Clearance Manufacturing Equipment:
    • During the line clearance of any Manufacturing Equipment following points shall be covered to check and verify in annexure no. 01.
    • Mentioned the Equipment ID No.
    • Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
    • Ensure the absence of batch documents; labels, materials, powder, tablets or any remnants of previous product or batch and traces of water on each dismantle part of the equipment.
    • Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
    • Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
    • Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
    • If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
    • If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
    • IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
    • Line Clearance Packing Cubical or Line:
    • During the line clearance of Packing Cubical or line following points shall be covered to check and verify in annexure no. 01.
    • Circled the word, which is applicable as Released/Not Released/ Hold/ Rejected/ Not applicable up to previous stage.
    • Mentioned the Room ID No./ Line No.
    • Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of previous product or batch.
    • Ensure updation of status board & ‘CLEANED’ label is affixed on each cleaned equipment.
    • Room conditions as Temperature, Relative Humidity and Differential Pressure are must be within limits.
    • Area status board for cleanliness shall include the clean status of return air raisers, supply air raisers, floor, ceiling, walls, drainage, light fixtures, dustbins, Containers, Tools, Vacuum cleaner, area surrounding the equipment.
    • Ensure that the absence of tablets, strips, blisters, plain aluminum foil, printed aluminum foil, PVC foil, PVDC foil of previous batch or product and oil/water leakages.
    • Above mentioned materials may be excess remaining or rejected during machine setting or on line rejected.
    • Ensure that the absence of the recoverable/rejected/defoiled strips, blisters or tablets.
    • Ensure that the overprinting stereos of previous product or batch are destroyed.
    • Batch Manufacturing Record of current batch, which is to be started, shall be completed up to production head sign and reviewed by IPQA.
    • If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
    • If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
    • IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
    • Line Clearance Packing Equipment:
    • During the line clearance of Packing Equipment following points shall be covered to check and verify in annexure no. 01.
    • Mentioned the Equipment ID No.
    • Ensure the absence of batch documents, labels, materials, powder, tablets or any remnants of previous product or batch and traces of water surrounding the equipment.
    • Ensure the absence of batch documents; labels, materials, powder, tablets, strips, blisters or any remnants of previous product or batch and traces of oil/water on each dismantle part or surrounding the equipment.
    • Ensure the absence of materials, powder, tablets or any remnants of previous product or batch and traces of water on each critical part of the equipment.
    • Critical & Dismantle parts of all equipment are varying from equipment to equipment. Name of the critical & dismantle parts of all equipment are mentioned individually in the line clearance checklist Annexure no. 01.
    • Recoverable, Rejected or defoiled strips/blisters/tablets of previous batch or product must be removed.
    • Weighing balances and Analytical balances of each area shall be cleaned and calibrated as per their frequency.
    • If complies Mark ‘√’ in respective blocks of Annexure No. I & mark ‘X’ if does not complies during line clearance.
    • If all points mentioned above are satisfactory, respective department shall sign ‘CLEANED’ label.
    • IPQA department shall sign ‘CLEANED’ label if product is approved from Quality Control Department up to previous stage.
    • Entry of primary, secondary & tertiary packing materials can be acceptable.
    • Machine setting and removal of proof shall be accepted. Production department shall sign proof, but machine could not run before getting line clearance from IPQA.
    • IPQA shall verify the proofs and can give final line clearance to start the batch packing only after getting the result of previous stage from quality control department.
    • In case if manual coding is to be carried out, for cartons and / or labels, following points shall be covered to check and verify in annexure no. 01.
    • Mentioned the Room ID No.
    • Ensure the absence of batch documents, labels, materials [Primary/Secondary/Tertiary packing materials] or any remnants of different product or batch.
    • Ensure updation of status board or ‘CLEANED’ label is affixed.
    • Area status board or affixed ‘CLEANED’ label for cleanliness shall include the clean status of floor, ceiling, walls, light fixtures, dustbins, Cage and surrounding area.
    • Ensure that the absence of printed, overprinted cartons of any different batch or product.
    • Ensure that the overprinting stereos of previous product or batch are destroyed.
    • Forms and Records.
    • Line Clearance Checklist of Area and Equipment for Manufacturing and related Area- Annexure -I
    • Distribution
      • Master Copy- Documentation Cell (QA)
      • Controlled Copies-Production and Quality Assurance
    • History
Date Revision

Number

Reason for revision
00 New SOP

     

MASTER FORMULA OF PHENYLEPHERINE HYDROCHLORIDE,CETRAZINE DIHYDROCHLORIDE ,ARACETAMOL & CAFFEINE ANHYDROUS TABLETS (drugsformulations.com)

                                                                 

  Annexure-I

  Line Clearance Checklist of Area and Equipment for Manufacturing and related Area

Dosage Form: Tablet Date / Time:
Product: Batch No.  :
Previous Product: Batch No.  :

Dispensing Room:

Sr. No. Check points Observations Done

By

Checked by Verified

By QA

Production Warehouse
DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable]
Room Identification number:
1 Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2 Ensure updation of status board & ‘CLEANED’ label is affixed on each equipment.
3 Cleanliness of Supply Air Grills of AHU.
4 Cleanliness of Return Air Grills of AHU.
5 Cleanliness of floor, ceiling, walls, drainage, light fixtures, dustbins, containers, tools, vacuum cleaner.
6 Area surrounding the dustbins, containers, tools and Balances.
7 Temperature [24 ± 2°c]
8 Relative Humidity [35 – 50 %]
9 Differential Pressure [10 – 26 Pascal]
10 Updation on status board  

 

Dispensing Booth:

Sr. No. Check points  Observations  Done

 By

Checked by  Verified  

By QA

Active Excipient Colour Production Warehouse
Room Identification number:
1 Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2 Ensure updation of status board/ status label on RLAF.
3 Ensure ‘CLEANED’ label is affixed on each cleaned equipment/tools/balances/IPC/Bins.
4 Cleanliness of Supply Air Grills of RLAF.
5 Cleanliness of Return Air Grills of RLAF.
6 Cleanliness of floor, RLAF walls, light fixtures, containers, tools and balances.
 7 Calibration of balances
8 Pressure differential across pre-filters.
9 Pressure differential across HEPA filters.

 Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / room & equipment Checks Checked By Verified By
Production QA
Vacuum cleaner Equipment ID No.: ____________________

  • Ensure the absence of batch documents, labels, powder, materials or remnants of previous product or batch.
  • Area surrounding the Equipment
ENSURE THE CLEANLINESS OF
  • Hose Pipe
  • Dust resisting filter
  • Dust Collecting Bag
  • Cleaned Label Present

 Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Dosage Form: Tablet Date / Time:
Product: Batch No.  :
Previous product: Batch No.  :
Stage areas / room & equipment Checks Checked By Verified By
Production QA
BINDER PREPARATION    [Released / Not Released / Hold / Rejected / Not Applicable]
Binder Preparation Area Room ID: ____________________

  • Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed on each equipment.
  • Ensure updation of Status Board
  • Temperature [24 ± 2°c]
  • Relative Humidity [35 – 50 %]
  • Differential Pressure [10 – 26 Pascal]
ENSURE THE CLEANLINESS OF
  • Floor
  • Walls
  • Ceiling
  • Drain
  • Supply air Grills
  • Containers
  • Tools
  • Vacuum cleaner
  • Waste Bins
  • Light Fixtures
  • Return air Grills
Steam Jacketed Vessel Equipment ID: ____________________

CLEANLINESS OF

  • Ensure the absence of batch documents, labels, materials, paste, traces of water or remnants of previous product or batch.
  • Cleaned Label Present
  • Area surrounding the Equipment
GRANULATION   [Released / Not Released / Hold / Rejected / Not Applicable]
Granulation Area Room ID: _____________________

  • Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.
  • Ensure ‘CLEANED’ label is affixed on each equipment.
  • Ensure updation of Status Board
  • Temperature [24 ± 2°c]
  • Relative Humidity [35 – 50 %]
  • Differential Pressure [10 – 26 Pascal]
ENSURE THE CLEANLINESS OF
  • Floor
  • Walls
  • Ceiling
  • Drain
  • Supply air Grills
  • Return air Grills
  • Light Fixtures
  • Waste Bins
  • Container
  • Tools
  • Vacuum cleaner
  • Area below the vibro Sifter.
  • Area below the  sifter cum multimill.
  • Area below the FBD/FBP.
  • Area below the RMG
  • Area below Tippler
  • Area below OGB
  • Area below Multi mill
  • Area below oscillating Granulator

 

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / room & equipment Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vibro Sifter Equipment ID No.: _____________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Intermediate Hopper

Cleaned Label Present

Gasket Integrity

Sieve Integrity

Discharge Chute

Wheels

Feed Hopper

Rapid Mixer Granulator Equipment ID No.: _____________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Bowl

Mixer Cone

Chopper

Charging Port

Agitator

Mixer Base

Cleaned Label Present

 

Discharge Valve

Gasket Integrity

Arm

Drain

Lid

Column

Vent filter (Product Specific, if applicable)
 Turbo Sifter cum Multimill Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / room & equipment Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Turbo Sifter cum Multimill CLEANLINESS OF

Feed hopper

Blade assembly

Vent Filter

Wheels

 Rotor

Gasket Integrity

Discharge Hopper

Cleaned Label Present

Quadracomill Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Feed Hopper

Discharge Assembly

Blade Assembly

 

Gasket Integrity

Wheels

Cleaned label present

Fluidized Bed Dryer/ Fluidized Bed Processor Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Gasket between the bowl & plenum

View glass integrity (intact)

Upper & lower Plenum

Product Bowl & Mesh.

Gasket integrity (intact)

Wheels of the bowl

Peristaltic Pump

Sampling Probe

Light assembly

Cleaned Label Present

Filter Bag

Retarding chamber

Exhaust end

Printer

Temperature probe

Tippler

 

Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Area surrounding the Equipment

CLEANLINESS OF

Stand

Cleaned Label Present

Cone

Valve

Gasket integrity

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / room & equipment Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Octagonal Blender Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Inside corners of the Blender

Cleaned Label Present

Rectangular Lid

 

Butterfly Valve

Top Closing Lid

Shaft & Baffles

Gasket Integrity

Ball mill Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Main chambers

Discharge Assembly

Ball Assembly

 

Gasket Integrity

Wheels

Cleaned label present

Oscillating Granulator Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Main chambers

Discharge Assembly

 

Wheels

Cleaned label present

Vacuum cleaner

 

Equipment ID No.: ____________________

Ensure the absence of batch document, labels, powder,materials or remnants of previous product or batch.

Area surrounding the Equipment

CLEANLINESS OF

Hose Pipe

Dust resisting filter

 

Dust Collecting Bag

Cleaned Label Present

Weighing Balances Instrument ID No.: ____________________

CLEANLINESS OF

Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

 Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BLENDING [Released / Not Released / Hold / Rejected / Not Applicable]
Blending Area Room ID: _____________________

Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

 

Area under the blender

Area under the vibro sifter

Supply air Grills

Return air Grills

Light Fixtures

Waste Bins

Vacuum cleaner

Octagonal Blender Equipment ID No.: ______________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Inside corners of the Blender

Cleaned Label Present

Rectangular Lid

 

Butterfly Valve

Top Closing Lid

Shaft & Baffles

Gasket Integrity

Vibro Sifter Equipment ID No.: _____________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

Vibro Sifter CLEANLINESS OF

Feed Hopper

Sieve Integrity

Gasket Integrity

Cleaned Label Present

Intermediate Hopper

Discharge Chute

Wheels

Tippler Equipment ID No.: ____________________

Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Stand

Cleaned Label Present

 

Cone

Valve

Gasket integrity

Vacuum cleaner Equipment ID No.: ____________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Area surrounding the Equipment

CLEANLINESS OF

Hose Pipe

Dust resisting filter

 

Dust Collecting Bag

Cleaned Label Present

 

Weighing Balances Instrument ID No.: ____________________

CLEANLINESS OF

Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable]
Compression

Cubicle

Room ID: _____________________

Ensure the absence of batch documents, labels, materials, powder, tablets,  or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

Waste Bins

Light Fixtures

Area under compression Machine

Area under the Deduster

Area under the Metal Detector

Area under the balances

Supply air Grills

Return air Grills

Vacuum cleaner

Compression Machine Equipment ID No.:_________________________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

All acrylic component integrity (intact)

Machine interior & hose pipes

Lower & Upper punch holes

Sleeve of the hopper

Forced Feeder assembly

Pressure Rollers

Discharge Chute

Lower & Upper cam tracks

Hopper

Turret

Die Cavities

Cleaned label present

Safety Guard

Dust Extractor Equipment ID No.: ____________________

Ensure the absence of powder.

CLEANLINESS OF

Hose Pipe

Dust Collecting SS pipe

Cleaned Label Present

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Metal Detector Equipment ID No.: ________________________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Chute assembly

Cleaned label present

Rejection Flap

Rejection Container

Solenoid cover

Deduster Equipment ID No.____________

Ensure the absence of batch documents, labels,  powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Perforated Plate

Discharge Chute

Cleaned Label present

Vacuum cleaner Equipment ID No.: ____________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Area surrounding the Equipment

CLEANLINESS OF

Hose Pipe

Dust resisting filter

Dust Collecting Bag

Cleaned Label Present

 

Weighing Balances Instrument ID No.: ___________

CLEANLINESS OF

Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

 

Stage areas / Equipment Name Checks Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

COATING [Released / Not Released / Hold / Rejected / Not Applicable]
Coating Room Room ID No.: ____________________

Ensure the absence of batch documents, labels, materials, powder, tablets,  or remnants of previous product or batch.

Ensure ‘CLEANED’ label is affixed on each equipment.

Ensure updation of Status Board

Temperature [24 ± 2°c]

Relative Humidity [35 – 50 %]

Differential Pressure [10 – 26 Pascal]

CLEANLINESS OF

Floor

Walls

Ceiling

Drain

Container

Tools

q Waste Bins

Light Fixtures

Area under coating Machine

Area under the Colloidal mill

Area under the coating solution

preparation tank

Area under the coating solution

storage tank

Area under the balance

Supply air Grills

Return air Grills

Auto-coater Equipment ID No.: ________________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch.

Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water or colour on each dismantle part.

Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part.

Area surrounding the Equipment

CLEANLINESS OF

Exhaust hood

Base of the Dosing Pump

Cleaned Label Present

Connecting Pipes

View Glass Integrity (intact)

Temperature probe

Sampling Probe

Light assembly

 

 

Hot air blower

Spray Guns

Baffles

Cabinet

Pan

Spray gun Bar

PLC assembly

Peristaltic Pump

Colloid Mill Equipment ID No.: _______________

Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour.

Colloid Mill CLEANLINESS OF

Cleaned Label Present

Rotor

Hopper

Hose pipe

Stator

Weighing Balances Instrument ID No.: ____________________

CLEANLINESS OF

Balance Platform

Balance display

Balances are Calibrated

Area surrounding the balance

Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.

Clotrimazole Tablet (drugsformulations.com)

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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