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PROCEDURE FOR LINE CLEARANCES

Posted on November 19, 2020December 31, 2023 By ABHA

PROCEDURE FOR LINE CLEARANCES

OBJECTIVE: To ensure that the area, equipment and activities required for the manufacturing and packing of pharmaceutical products are free from any potential sources of cross contamination / mix-ups (Line clearance).

2.0 SCOPE: The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.

3.0 Responsibility : In – process quality Assurance Executive/Officer.

4.0  ACCOUNTABILITY:

Quality Assurance Manager.

5.0  PROCEDURE

5.1 Verify the following points before giving clearance for activity which has to be started after it has been checked by Production Executive / Officer in dispensing and manufacturing area.

5.1.1 Machine status for cleanliness and cleaned label is affixed.

5.1.2 Area status for cleanliness including dust bins, walls, return raisers.

5.1.3 Status labels of Bins, IPCs, Sieves, equipments, RLAF etc. to be used during manufacturing.

5.1.4 Release status of the product till the previous stage if applicable.

5.1.5 Calibration status of weighing balances.

5.1.6 Batch details of the product to be started should be displayed on the display board.

5.1.7 Rh, temperature and pressure differential of that particular room in which activity has to start along with the pressure differential of RLAF (If applicable).

5.1.8 Clearance by swab analysis in case of product changes over.

5.2    For Activities in Dispensing Area 

5.2.1 After verification of Point Nos. 5.1.1 to 5.1.8, check the materials to be dispensed.

5.2.2 The raw materials should be approved by QC.

5.2.3 Verify the calculations for dispensing in the BMR.

5.2.4 The ‘Cleaned’ tags shall be signed by IPQA Officer / Executive at the start of the activity as a verification. This shall mean that line clearance has been given for dispensing.

5.2.5 Line clearance in BMR can either be given by Production or IPQA officer / Executive.

5.3    For Activities in Manufacturing Area 

5.3.1  After verification of Point Nos. 5.1.1 to 5.1.8, check the batch record completion till previous stage.

5.3.2  The ‘Cleaned’ tags shall be signed by IPQA Officer / Executive at the start of the activity as a verification. This shall mean that line clearance has been given to a particular process.

5.3.3 Line clearance in BMR can be given either by Production or IPQA officer / Executive.

5.4    For Filling and Compression

  • After verification of Point Nos. 5.1.1 to 5.1.8, the initial checks for capsules filling or tablets compression shall be carried out.

5.4.2  If these checks are found satisfactory, the line clearance shall be given.

5.4.3 ‘Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.

5.4.4  ‘Non – recoverable’ tags shall be signed by Production Officer / Executive at the time of start and IPQA Officer/  Executive shall sign it after completion of the batch.

5.5   For Primary Packing 

5.5.1 Check the Rh, temperature and pressure differential of that particular room in which activity has to start.

5.5.2 Machine status for cleanliness for each machine like Blister packing machine, Strip packing machine etc.

5.5.3 In case a different product is to be started, make sure that the machine change over is completed and the machine is clean and no previous product leftover.

5.5.4 Check the area cleanliness, belt and conveyor cleanliness.

5.5.5 Ensure that no trace of any material of the previous product is present in the area and machine parts.

5.5.6 Ensure the following details of the batch to be packed:

  • Batch Number
  • Manufacturing Date
  • Expiry Date
  • CST recoverable (If applicable)
  • Registration Number (If applicable) and
  • Retail Price (If applicable)

5.5.7 The product to be started is mentioned on the display board along with the batch size, Pkg. Qty., and other details as per Point No. 5.5.6

5.5.8  Approved primary packaging components are present.

5.5.9  Specimen of label / Foil / Carton are available and they are duly signed by Production Officer / Executive with details as per point No. 5.5.6.

5.5.10  The specimen shall be verified with BPR for details as mentioned in 5.5.6.

5.5.11   Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.

5.6        For Secondary Packing 

5.6.1     After verification from Point Nos. 5.5.4 to 5.5.10, counter sign the ‘Line Clearance’ at the start of the activity as  verification. This shall mean that line clearance has been given to the particular process.

5.6.2   Sign the ‘Line Clearance’ tags and in BPR at appropriate places.

5.6.3 In case if manual coding is to be carried out, for labels and / or cartons, the line clearance shall be given according to Point No. 5.1.4 and Point Nos. 5.5.4 to 5.5.10.

5.6.4  Ensure balances are in calibration state and leveling done.

Attachments – I

Line Clearance Checklist

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous Product:Batch No.  :

Dispensing Room:

Sr. No.Check points

Observations

Done

By

Checked byVerified

By QA

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

Dispensing Booth: 

Sr. No.Check points Observations Done

 By

Checked by Verified  

By QA

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

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

 Vacuum cleaner: 

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vacuum cleanerEquipment ID No.: ____________________

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

q Area surrounding the Equipment

CLEANLINESS OF

q Hose Pipe

q Dust resisting filter

q Dust Collecting Bag

q Cleaned Label Present

 

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

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

Stage areas / room & equipment

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable]
Binder Preparation AreaRoom 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

Supply air Grills

Containers

Tools

Vacuum cleaner

Waste Bins

Light Fixtures

Return air Grills

Steam Jacketed VesselEquipment 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 AreaRoom 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

Supply air Grills

Return air Grills

Light Fixtures

Waste Bins

Container

Tools

Vacuum cleaner

q Area below the vibro Sifter.

q Area below the Turbo sifter

cum multimill.

Area below the FBD/FBP.

Area below the RMG

Area below Tippler

Area below OGB

Area below Ball mill

Area below oscillating Granulator

Area below the Quadroco

Mill

       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 SifterEquipment 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 GranulatorEquipment 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 MultimillEquipment 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 MultimillCLEANLINESS OF

Feed hopper

Blade assembly

Vent Filter

Wheels

Rotor

Gasket Integrity

Discharge Hopper

Cleaned Label Present

QuadracomillEquipment 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 ProcessorEquipment 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 BlenderEquipment 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 millEquipment 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 GranulatorEquipment 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

 

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

Weighing BalancesInstrument 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.

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

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 AreaRoom 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 BlenderEquipment 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 SifterEquipment 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 / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Vibro SifterCLEANLINESS OF

Feed Hopper

Sieve Integrity

Gasket Integrity

Cleaned Label Present

Intermediate Hopper

Discharge Chute

Wheels

TipplerEquipment 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 cleanerEquipment 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 BalancesInstrument 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.

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

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 MachineEquipment 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 ExtractorEquipment ID No.: ________________

Ensure the absence of powder.

CLEANLINESS OF

Hose Pipe

Dust Collecting SS pipe

Cleaned Label Present

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

Metal DetectorEquipment 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

DedusterEquipment 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 cleanerEquipment 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 BalancesInstrument 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.

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

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 RoomRoom 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

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-coaterEquipment 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 MillEquipment 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.

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

Colloid MillCLEANLINESS OF

Cleaned Label Present

Rotor

Hopper

Hose pipe

Stator

Weighing BalancesInstrument 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.

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable]
Inspection AreaRoom 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

Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

Area under Inspection Machine

Area under the balance

Inspection MachineEquipment 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.

CLEANLINESS OF

Base of the belt

Illumination of the belt

Cleaned label present

Reject tray

Integrity of rollers

 Conveyor belt

Hopper

Tablet modifier

Inside the belt

Rollers

Manual InspectionRoom 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]

SS trays

Inspection Table

Weighing BalancesInstrument 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.

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  :

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing RoomRoom 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

q Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

Area under packing Machine

Blister Packing Machine / Strip packing machine / Defoiling MachineEquipment ID No.: _________________

Ensure the absence of materials / Powder / tablets / Aluminum foil / PVC foil / PVDC foil / Printed foil / Strips / Blisters or remnants of previous product or batch & traces of water.

Pass box cleanliness.

Overprinting Stereos of previous batch or product are destroyed.

Area surrounding the Equipment

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

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  : 

 

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

PACKING [Released / Not Released / Hold / Rejected / Not Applicable]
Packing LineLine 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

 

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Packing LineCLEANLINESS OF
Floor

Walls

Ceiling

Container

Carets

 Tools

Waste Bins

Supply air Grills

Return air Grills

Light Fixtures

Conveyer BeltEquipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

Cartooning MachineEquipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

Online check weigherEquipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

Shipper sealing machineEquipment ID No.: __________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

Shipper weighing balanceEquipment ID No.: ___________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

Shipper strapping machineEquipment ID No.: __________________

Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch.

Area surrounding the Equipment

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

Dosage Form:TabletDate / Time:
Product:Batch No.  :
Previous product:Batch No.  : 

 

  

Stage areas / Equipment Name

Checks

Checked by

Production

Date & Time

Counter checked By Quality Assurance

Date & Time

Manual Coding RoomRoom ID No.: ____________________

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

Ensure ‘CLEANED’ label is affixed.

CLEANLINESS OF

Floor

Walls

Ceiling

Container

 Light Fixtures

Tools

Waste Bins

Supply air Grills

Return air Grills

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

PackingEquipment ID No.: _________________

Approval of Intermediate product of current batch.

BMR of current batch completed up to previous stage.

Machine operation clearance.

 

 

SOPs Tags:Aberdeenshire, Abu Dhabi, Abu Dhalouf, Abu Hamour, Abu Samra, ABUJA, ACCRA, Acre, Ad Dawhah al Jadidah, ADDIS ABABA, Adelaide, AFGHANISTAN, Agra, Agrigento, Ahmedabad, Aïn Beïda, Ain Khaled, Ain Sinan, Ajman, Ajman and Ra’s al-Khaimah, Ajmer, Al Ain, Al Aziziya, Al Bidda, Al Daayen, Al Dafna, Al Ebb, Al Egla, Al Gharrafa, Al Ghuwariyah, Al Hilal, Al Jasrah, Al Jeryan, Al Karaana, Al Kharaitiyat, Al Kharayej, Al Kharrara, Al Kheesa, Al Khor, Al Khulaifat, Al Luqta, Al Mamoura, Al Mansoura, Al Markhiyah, Al Mashaf, Al Masrouhiya, Al Mearad, Al Messila, Al Mirqab, Al Najada, Al Nasraniya, Al Qassar, Al Rufaa, Al Sadd, Al Sailiya, Al Sakhama, Al Seej, Al Shagub, Al Souq, Al Tarfa, Al Thakhira, Al Themaid, Al Thumama (Al Wakrah), Al Thumama (Doha), Al Utouriya, Al Waab, Al Wajba, Al Wakrah, Al Wukair, Al Zubarah, Al-Shahaniya, Alagoas, ALBANIA, Alberta, Alessandria, ALGERIA, Algiers, Aligarh, Allahabad, Allerdale, Amapa, Amazonas, Amber Valley, Amersham, AMMAN, Ampthill, Amravati, Amritsar, Amsterdam, Amur, Ancona, and Craigavon, and Down, ANDORRA, ANDORRA LA VELLA, ANGOLA, Angus, ANKARA, Annaba, ANTANANARIVO, ANTIGUA & BARBUDA, Antrim and Newtownabbey, Antwerp, Aosta, APIA, Ar Ru'ays, Ards and North Down, ARGENTINA, Argyll and Bute, Arkhangelsk, Arlington, Armagh, ARMENIA, As Salatah, Ascoli Piceno, Ashbourne, ASHGABAT, ashington, Ashland, Ashmore and Cartier Islands, ASMARA, Asti, Astrakhan, ASUNCIÓN, Athens, Auckland, Aurangabad, AUSTRALIA, Australian Antarctic Territory, Australian Capital Territory, Austria, Avellino, Aylesbury, Aylesbury Vale, AZERBAIJAN, Baaya, BAGHDAD, BAHAMAS, Bahia, BAHRAIN, BAKU, BAMAKO, Banbridge, BANDAR SERI BEGAWAN, Bangalore, BANGKOK, BANGLADESH, Bangor, BANGUI, Bani Hajer, BANJUL, Barahat Al Jufairi, BARBADOS, Barcelona, Bareilly, Bari, Barletta-Andria-Trani, Barrow-in-Furness, BASSETERRE, Bath, Batna, Bavaria, Beaconsfield, Béchar, Bedford, BEIJING, BEIRUT, Béjaïa, Belarus, Belfast, Belgium, Belgorod, Belgrade, BELIZE, Belluno, BELMOPAN, Belper, Benevento, BENIN, Bergamo, Berlin, BERN, Bhavnagar, Bhilai Nagar, Bhiwandi, Bhopal, Bhubaneswar Salem, BHUTAN, Biella, Bikaner, Birmingham, Birmingham (West Midlands), BISHKEK, Biskra, BISSAU, Blackburn with Darwen, Blackpool, Blaenau Gwent, Blida, BLOEMFONTEIN, Bloomsbury, Bodmin, BOGOTÁ, BOLIVIA, Bologna, Bolsover, Bordj Bou Arreridj, BOSNIA & HERZEGOVINA, BOTSWANA, Bou Saâda, Bournemouth, Bracknell Forest, Bradford, BRASILIA, BRATISLAVA, BRAZIL, BRAZZAVILLE, Bremen, Brescia, Bridgend, BRIDGETOWN, Brighton, Brighton and Hove, Brindisi, Brisbane, Bristol, British Columbia, BRUNEI, BRUSSELS, Brussels-Capital Region, Bryansk, Bu Fasseela, Bu Samra, Bu Sidra, Bucharest, Buckinghamshire, Budapest, BUENOS AIRES, BUJUMBURA, Bulgaria, BURKINA FASO, Burlington, BURUNDI, Buxton, CABO VERDE, Caerphilly, Cagliari, CAIRO, Caltanissetta, CAMBODIA, Cambridge, Cambridgeshire, Camden, CAMEROON, Campobasso, canada, Canberra, Canterbury, CAPE TOWN, Cardiff, Carlisle, Carmarthenshire, Caserta, CASTRIES, Catania, Catanzaro, Causeway Coast and Glens, Ceara, Centerville, CENTRAL AFRICAN REPUBLIC, Central Bedfordshire, Ceredigion, CHAD, Chalfont St. Giles, Chandigarh, Charlottetown, Chelmsford, Chelyabinsk, Chennai, Cheshire East, Cheshire West and Chester, Chester, Chesterfield, Chichester, Chieti, CHILE, Chiltern, CHINA, Chlef, Christmas Island, City of London, Clackmannanshire, Clayton, Cleveland, Clinton, Clydebank, Coatbridge, Cockermouth, Cocos (Keeling) Islands, Coimbatore, Coldstream, COLOMBIA, COLOMBO, Como, COMOROS, CONAKRY, Congleton, CONGO, Constantine, Conwy, Copeland, Copenhagen, Coral Sea Islands, Cornwall, Cosenza, COSTA RICA, CÔTE D'IVOIRE(Ivory Coast), Coventry, Cremona, Crewe, CROATIA, Cromarty, Crotone, CUBA, Cumbernauld, Cumbria, Cuneo, Cuttack, CYPRUS, Czech Republic, CZECH REPUBLIC (Czechia), Dahl Al Hamam, DAKAR, Dalkeith, DAMASCUS, Darlington, Darwin, Dayton, Dehradun Garhwali, Delhi, Denbighshire, denmark, Derby, Derbyshire, Derbyshire Dales, Derry, Derry and Strabane, Devon, DHAKA, Djelfa, DJIBOUTI, DJIBOUTI (CITY), DODOMA, Doha, Dombivali, DOMINICA, DOMINICAN REPUBLIC, Donetsk, Dorset, Dover, dubai, Dublin, Duhail, Dukhan, Dumfries and Galloway, Dunbar, Dundee, Dunkeld, Duns, Dunstable, Durgapur Asansol, Durham, DUSHANBE, East Ayrshire, East Devon, East Dunbartonshire, EAST JERUSALEM, East Lothian, East Midlands, East of England, East Renfrewshire, East Riding of Yorkshire, East Sussex, ECUADOR, Eden, Edinburgh, Edmonton, EGYPT, El Eulma, El Oued, EL SALVADOR, Elgin, Ely, England, Enna, EQUATORIAL GUINEA, Erewash, ERITREA, Espirito Santo, Essex, estado, estados, ESTONIA, ESWATINI (formerly Swaziland), ETHIOPIA, Exeter, Fairview, Falkirk, Falmouth, Faridabad, Fenland, Fereej Abdel Aziz, Fereej Al Amir, Fereej Al Asiri, Fereej Al Asmakh, Fereej Al Manaseer, Fereej Al Murra, Fereej Al Nasr, Fereej Al Soudan, Fereej Al Zaeem, Fereej Bin Durham, Fereej Bin Mahmoud, Fereej Bin Omran, Fereej Kulaib, Fereej Mohammed Bin Jassim, Fermanagh and Omagh, Fermo, Ferrara, Fife, FIJI, Finland, Firozabad, Flintshire, Florence, Foggia, Forlì-Cesena, Forres, Fort William, Fowey, FRANCE, Frankfurt Rhine-Main Region, Franklin, Fredericton, FREETOWN SINGAPORE, Frosinone, Fujairah, FUNAFUTI, Fuwayrit, GABON, GABORONE, Galashiels, GAMBIA, Genoa, Georgetown, GEORGIA, Germany, GHANA, Gharrafat Al Rayyan, Ghaziabad, Glasgow, Gloucester, Gloucestershire, Goias, Gorakhpur, Gorizia, Grasmere, Greater Glasgow, Greater London, Greater Manchester, greece, Greenock, Greenville, GRENADA, Grosseto, GUATEMALA, GUATEMALA CITY, Guelma, GUINEA, GUINEA-BISSAU, Gujarati, Gulbarga, Guntur, Gurgaon, Guwahati, GUYANA, Gwalior, Gwynedd, Haddington, HAITI, Halifax, Halton, Hamad Medical City, Hamburg, Hampshire, Haora, HARARE, Hartlepool, HAVANA, Hawick, Hawke's Bay, Hazm Al Markhiya, Heard Island and McDonald Islands, Helsinki, Helston, Hereford, Herefordshire, Hertfordshire, Hesse, High Peak, High Wycombe, Highland, Hobart, HONDURAS, HONIARA, Hove, Hubli and Dharwad, Hudson, Hungary, Huntingdon, Huntingdonshire, hyderabad, ICELAND, Imperia, INDONESIA, Indore, Inverclyde, Invergordon, Inverness, Iqaluit, IRAN, IRAQ, ireland, Irkutsk, Irvine, Isernia, ISLAMABAD, Isle of Anglesey, Isle of Wight, Isles of Scilly, ISRAEL, Istanbul, Italy, Ivanovo, Izghawa (Al Rayyan), Izghawa (Umm Salal), Jabal Thuaileb, Jabalpur, Jackson, Jaipur, JAKARTA, Jalandhar, JAMAICA, Jammu, Jamnagar, Jamshedpur, JAPAN, Jelaiah, JERUSALEM, Jervis Bay Territory, Jeryan Jenaihat, Jeryan Nejaima, Jhansi, Jijel, Jodhpur, JORDAN, JUBA, KABUL, Kaliningrad, Kaluga, Kalyan, KAMPALA, Kanpur, KATHMANDU, Katowice urban area, KAZAKHSTAN, Kazan, Kemerovo, Kendal, Kent, KENYA, Keswick, Kharkiv, KHARTOUM, Khawr al Udayd, Kiev, KIGALI, Kingston, Kingston upon Hull, KINGSTOWN, Kinross, KINSHASA, KIRIBATI, Kirkintilloch, Kirkwall, Kirov, Knutsford, Kochi, Kolkata, KOSOVO, Kostroma, Kota, Kraków, KUALA LUMPUR, Kurgan, Kursk, Kuwait, KUWAIT CITY, KYRGYZSTAN, L'Aquila, La Spezia, Laghouat, Lancashire, Lancaster, LAOS, Latina, LATVIA, Launceston, Leabaib, Lebanon, Lebday, Lecce, Lecco, Leeds, Leicester, Leicestershire, Lejbailat, Lekhwair, Leningrad, Leqtaifiya (West Bay Lagoon), LESOTHO, Lexington, LIBERIA, LIBREVILLE, LIBYA, Lichfield, LIECHTENSTEIN, Lijmiliya, Lille–Kortrijk–Tournai France/ Belgium, LILONGWE, LIMA, Lincoln, Lincolnshire, Lipetsk, Lisbon, Lisburn, Lisburn and Castlereagh, LITHUANIA, Liverpool, Livorno, LJUBLJANA, LOMÉ, london, Loni, Looe, Lossiemouth, Lostwithiel, Luaib, LUANDA, Lucca, Lucknow, Ludhian, Lusail, LUSAKA, Luton, LUXEMBOURG, M'Sila, Macclesfield, Macerata, MADAGASCAR, Madinat Al Kaaban, Madinat ash Shamal, Madinat Khalifa North, Madinat Khalifa South, Madison, Madrid, Madurai, Magadan Moscow, Maghnia, MAJURO, MALABO, MALAWI, MALAYSIA, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Mascara, MASERU, Massa and Carrara, Matera, Matlock, Mato Grosso, Mato Grosso do Sul, MAURITANIA, MAURITIUS, MBABANE, Mebaireek, Médéa, Medway, Meerut, Mehairja, Melbourne, Merseyside, Merthyr Tydfil, Mesaieed, Mesaimeer, Messina, MEXICO, MEXICO CITY, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minsk, Modena, MOGADISHU, Monmouthshire, MONROVIA, MONTEVIDEO, Monza and Brianza, Moradabad, Moray, MORONI, Moscow, Mostaganem, Motherwell and Wishaw, Mount Vernon, Mourne, Muaither, Mumbai, Muraikh, Murmansk, MUSCAT, Mushayrib, Mysore, N'DJAMENA, Nagpur, NAIROBI, Najma, NAMIBIA WINDHOEK, Nanded Kolapur, Nantwich, Naples, Nashik, NASSAU, NAURU, Navi Mumbai, Neath Port Talbot, Nellore, Nelson, NEPAL, Netherlands, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Plymouth, New Salata, New South Wales, NEW ZEALAND, Newfoundland and Labrador, Newport, NewportAuburn, Newquay, Newry, NGERULMUD, NIAMEY, NICARAGUA, NICOSIA, NIGER, NIGERIA, Nizhniy Novgorod, Nizhny, Noida, Norfolk, Norfolk Island, North, North Ayrshire, North East, North East Derbyshire, North East Lincolnshire, NORTH KOREA, North Lanarkshire, North Lincolnshire, NORTH MACEDONIA, North Somerset, North West, North Yorkshire, Northamptonshire, Northern, Northern Ireland, Northern Territory, Northumberland, Northwest Territories, Northwich, Norway, Norwich, Nottingham, Nottinghamshire, NOUAKCHOTT, Nova Scotia, Novara, Novgorod, Novosibirsk, Nu`ayjah, Nunavut, Nuoro, NUR-SULTAN, Nuremberg, Oakland, Old Al Ghanim, Old Al Hitmi, Old Al Rayyan, OMAN, Omsk, Onaiza, Ontario, OntarioToronto, Oran, Orenburg, Oristano, Orkney Islands, Oryol, OSLO, Otago, Ottawa, OUAGADOUGOU, Ouargla, Oxford, Oxfordshire, Padua, Paisley, PAKISTAN, PALAU, Palermo, PALESTINE, PANAMA, PANAMA CITY, PAPUA NEW GUINEA, Para, PARAGUAY, Paraiba, PARAMARIBO, Parana, Paris, Parma, Patna, Pavia, Pembrokeshire, Penrith, Penryn, Penza, Penzance, Pernambuco, Perth, Perth and Kinross, PERU, Perugia, Pesaro and Urbino, Pescara, Peterborough, PHILIPPINES, PHNOM PENH, Piacenza, Piaui, Pimpri, Pisa, Pistoia, Plymouth, Poland, Poole, Pordenone, PORT LOUIS, PORT MORESBY, PORT OF SPAIN, PORT VILA, PORT-AU-PRINCE, Porto Portugal, PORTO-NOVO, Portsmouth, portugal, Potenza, Powys, Prague, PRAIA, Prato, Preston, PRETORIA, Prince Edward Island, PRISTINA, Pskov, Pune, PYONGYANG, QATAR, Quebec, Quebec City, Queensland, QUITO, Ragusa, Raipur, Rajkot, Ramsey, Ranchi, Ras Abu Aboud, Ras Al Khaimah, Ras Lafan, Ravenna, Rawdat Al Hamama, Rawdat Al Khail, Rawdat Egdaim, Rawdat Rashed, Reading, Redcar and Cleveland, Reggio Calabria, Reggio Emilia, Regina, Relizane, Renfrew, Renfrewshire, Repton, REYKJAVIK, Rhondda Cynon Taf, Rieti, RIGA, Rimini, Rio de Janeiro, Rio Grande, Ripon, Riverside, RIYADH, Romania, Rome, ROSEAU, Rostov, Rotterdam, Rovigo, Rumeilah, Russia, Rutland, RWANDA, Ryazan, Saharanpur, Saïda, SAINT GEORGE'S, SAINT JOHN'S, SAINT KITTS & NEVIS, SAINT LUCIA, Saint Petersburg, SAINT VINCENT & THE GRENADINES, Sakhalin, Salem, Salerno, Salford, Salisbury, Saltash, Samara, SAMOA, SAN JOSE, SAN MARINO, SAN SALVADOR, Sandhurst, SANTIAGO, SANTO DOMINGO, SÃO TOMÉ & PRÍNCIPE, SÃO TOMÉ SAUDI ARABIA, SARAJEVO, Saratov, Saskatchewan, Sassari, Savona, Sawda Natheel, Saxony, Scotland, Scottish Borders, SENEGAL, SEOUL, Separate tags with commas, Serbia, Sétif, Seville, SEYCHELLES, Shagra, Sharjah, Sheffield, Shetland Islands, Shropshire, Sidi bel Abbès, Siena, SIERRA LEONE, Siliguri, Simaisma, singular, Skikda, SKOPJE, Slough, SLOVAKIA, SLOVENIA, Smolensk, Sofia, Solapur, SOLOMON ISLANDS, SOMALIA, Somer, Somer en

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