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: | 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.
Vacuum cleaner:
Stage areas / room & equipment |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
|
Vacuum cleaner | Equipment 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
|
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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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
|||
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] |
|||||
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 |
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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] |
|||||
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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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 |
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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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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
|
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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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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
|
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / room & equipment |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
|||
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.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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 |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
||||||
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.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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 |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & 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 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. |
Note: Mark ‘√’ if complies & mark ‘X’ if does not complies during line clearance.
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
|||||
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.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
||||||||
INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||||||
Inspection Area | 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 Light Fixtures |
Tools
Waste Bins Supply air Grills Return air Grills Area under Inspection Machine Area under the balance |
||||||||||
Inspection Machine | 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. |
||||||||||
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 Inspection | 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] SS trays Inspection Table |
||||||||||
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.
Dosage Form: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
||||
PACKING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||
Packing 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 |
q Light Fixtures
Tools Waste Bins Supply air Grills Return air Grills Area under packing Machine |
||||||
Blister Packing Machine / Strip packing machine / Defoiling Machine | Equipment 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: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
|
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
||
PACKING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||
Packing Line | Line 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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
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Packing Line | CLEANLINESS OF | |||||||
Floor
Walls Ceiling Container Carets |
Tools
Waste Bins Supply air Grills Return air Grills Light Fixtures |
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Conveyer Belt | Equipment 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 |
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Cartooning Machine | Equipment 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 |
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Online check weigher | Equipment 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 |
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Shipper sealing machine | Equipment 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 |
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Shipper weighing balance | Equipment 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 |
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Shipper strapping machine | Equipment 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: | Tablet | Date / Time: | |
Product: | Batch No. : | ||
Previous product: | Batch No. : |
|
Stage areas / Equipment Name |
Checks |
Checked byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
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Manual Coding Room | Room ID No.: ____________________
Ensure the absence of batch documents, labels, materials, or remnants of previous product or batch. Ensure ‘CLEANED’ label is affixed. |
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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 byProductionDate & Time |
Counter checked By Quality AssuranceDate & Time |
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Packing | Equipment ID No.: _________________
Approval of Intermediate product of current batch. BMR of current batch completed up to previous stage. Machine operation clearance. |