Procedure for line clearances. Quality assurance
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).
SCOPE
The line clearance procedure is applicable to all the activities including dispensing, manufacturing, packaging and related activities.
Responsibility
In – process quality Assurance Executive/Officer.
ACCOUNTABILITY
Quality Assurance Manager.
PROCEDURE
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.
Machine status for cleanliness and cleaned label is affixed.
Area status for cleanliness including dust bins, walls, return raisers.
Status labels of Bins, IPCs, Sieves, equipments, RLAF etc. to be used during manufacturing.
Release status of the product till the previous stage if applicable.
Calibration status of weighing balances.
Batch details of the product to be started should be displayed on the display board.
Rh, temperature and pressure differential of that particular room in which activity has to start along with the pressure differential of RLAF (If applicable).
Clearance by swab analysis in case of product changes over.
For Activities in Dispensing Area
After verification, check the materials to be dispensed.
The raw materials should be approved by QC.
Verify the calculations for dispensing in the BMR.
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.
Line clearance in BMR can either be given by Production or IPQA officer / Executive.
For Activities in Manufacturing Area
After verification, check the batch record completion till previous stage.
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.
Line clearance in BMR can be given either by Production or IPQA officer / Executive.
For Filling and Compression
After verification, the initial checks for capsules filling or tablets compression shall be carried out.
If these checks are found satisfactory, the line clearance shall be given.
‘Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.
‘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.
For Primary Packing
Check the Rh, temperature and pressure differential of that particular room in which activity has to start.
Machine status for cleanliness for each machine like Blister packing machine, Strip packing machine etc.
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.
Check the area cleanliness, belt and conveyor cleanliness.
Ensure that no trace of any material of the previous product is present in the area and machine parts.
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)
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
Approved primary packaging components are present.
Specimen of label / Foil / Carton are available and they are duly signed by Production Officer / Executive with details.
The specimen shall be verified with BPR for details6.
‘Recoverable’ tags shall be signed by Production as well as IPQA Officer / Executive for that particular batch.
For Secondary Packing
After verification, 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.
Sign the ‘Line Clearance’ tags and in BPR at appropriate places.
In case if manual coding is to be carried out, for labels and / or cartons, the line clearance.
Ensure balances are in calibration state and leveling done.
Forms and Records (Annexures)
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR MANUFACTURING & RELATED AREA
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History
Annexure-1
LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR MANUFACTURING & RELATED AREA
Dosage Form: Tablet
Date / Time:
Product:
Batch No. :
Previous Product:
Batch No. :
Dispensing Room:
DISPENSING AREA [Released / Not Released / Hold / Rejected / Not Applicable]
Room Identification number:
- 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 equipment.
- Cleanliness of Supply Air Grills of AHU.
- Cleanliness of Return Air Grills of AHU.
- Cleanliness of floor, ceiling, walls, drainage, light fixtures, dustbins, containers, tools, vacuum cleaner.
- Area surrounding the dustbins, containers, tools and Balances.
- Temperature [24 ± 2°c]
- Relative Humidity [35 – 50 %]
- Differential Pressure [10 – 26 Pascal]
- Updation on status board
Dispensing Booth:
- Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
- Ensure updation of status board/ status label on RLAF.
- Ensure ‘CLEANED’ label is affixed on each cleaned equipment/tools/balances/IPC/Bins.
- Cleanliness of Supply Air Grills of RLAF.
- Cleanliness of Return Air Grills of RLAF.
- Cleanliness of floor, RLAF walls, light fixtures, containers, tools and balances.
- Calibration of balances
- The pressure differential across pre-filters.
- Pressure differential across HEPA filters.
Vacuum cleaner:
Equipment ID No.: ____________________
Ensure the absence of batch documents, labels, powder, materials or remnants of previous product or batch.
The area surrounding the Equipment
CLEANLINESS OF
- Hose Pipe
- Dust resisting filter
- Dust Collecting Bag
- Cleaned Label Present
BINDER PREPARATION [Released / Not Released / Hold / Rejected / Not Applicable]
Room ID: ____________________
- Ensure the absence of batch documents, labels, materials or remnants of previous product or batch.
- Ensure the ‘CLEANED’ label is affixed on each piece of equipment
- Ensure updation of the 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
| GRANULATION [Released / Not Released / Hold / Rejected / Not Applicable] | ||||||
| Granulation Area | Room ID: _____________________
o Ensure the absence of batch documents, labels, materials or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] o Differential Pressure [10 – 26 Pascal] |
|||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Supply air Grills o Return air Grills o Light Fixtures o Waste Bins o Container o Tools o Vacuum cleaner |
o Area below the vibro Sifter.
o Area below the Turbo sifter cum multimill. o Area below the FBD/FBP. o Area below the RMG o Area below Tippler o Area below OGB o Area below Ball mill o Area below oscillating Granulator o 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 Sifter | Equipment ID No.: _____________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Intermediate Hopper o Cleaned Label Present o Gasket Integrity |
o Sieve Integrity
o Discharge Chute o Wheels o Feed Hopper |
||||||
| Rapid Mixer Granulator | Equipment ID No.: _____________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Bowl o Mixer Cone o Chopper o Charging Port o Agitator o Mixer Base o Cleaned Label Present |
o Discharge Valve
o Gasket Integrity o Arm o Drain o Lid o Column |
||||||
| o Vent filter (Product Specific, if applicable) | |||||||
| Turbo Sifter cum Multimill | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o 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
o Feed hopper o Blade assembly o Vent Filter o Wheels |
o Rotor
o Gasket Integrity o Discharge Hopper o Cleaned Label Present |
|||||
| Quadracomill | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Feed Hopper o Discharge Assembly o Blade Assembly |
o Gasket Integrity
o Wheels o Cleaned label present |
||||||
| Fluidized Bed Dryer/ Fluidized Bed Processor | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Gasket between the bowl & plenum o View glass integrity (intact) |
|||||||
| o Upper & lower Plenum
o Product Bowl & Mesh. o Gasket integrity (intact) o Wheels of the bowl o Peristaltic Pump o Sampling Probe o Light assembly |
o Cleaned Label Present
o Filter Bag o Retarding chamber o Exhaust end o Printer o Temperature probe |
||||||
| Tippler | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Stand o Cleaned Label Present |
o Cone
o Valve o 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.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
|||||||
| CLEANLINESS OF
o Inside corners of the Blender o Cleaned Label Present o Rectangular Lid |
o Butterfly Valve
o Top Closing Lid o Shaft & Baffles o Gasket Integrity |
|||||||
| Ball mill | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
|||||||
| CLEANLINESS OF
o Main chambers o Discharge Assembly o Ball Assembly |
o Gasket Integrity
o Wheels o Cleaned label present |
|||||||
| Oscillating Granulator | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
|||||||
| CLEANLINESS OF
o Main chambers o Discharge Assembly |
o Wheels
o Cleaned label present |
|||||||
| Vacuum cleaner | Equipment ID No.: ____________________
o Ensure the absence of batch document, labels, powder, materials or remnants of previous product or batch. o Area surrounding the Equipment |
|||||||
| CLEANLINESS OF
o Hose Pipe o Dust resisting filter |
o Dust Collecting Bag
o Cleaned Label Present |
|||||||
| Stage areas / room & equipment | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
|||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
| BLENDING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||
| Blending Area | Room ID: _____________________
o Ensure the absence of batch documents, labels, materials or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] o Differential Pressure [10 – 26 Pascal] |
||||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container o Tools |
o Area under the blender
o Area under the vibro sifter o Supply air Grills o Return air Grills o Light Fixtures o Waste Bins o Vacuum cleaner |
||||||
| Octagonal Blender | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Inside corners of the Blender o Cleaned Label Present o Rectangular Lid |
o Butterfly Valve
o Top Closing Lid o Shaft & Baffles o Gasket Integrity |
||||||
| Vibro Sifter | Equipment ID No.: _____________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| Stage areas / room & equipment | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
|||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
| BLENDING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||
| Blending Area | Room ID: _____________________
o Ensure the absence of batch documents, labels, materials or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] o Differential Pressure [10 – 26 Pascal] |
||||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container o Tools |
o Area under the blender
o Area under the vibro sifter o Supply air Grills o Return air Grills o Light Fixtures o Waste Bins o Vacuum cleaner |
||||||
| Octagonal Blender | Equipment ID No.: ______________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o Inside corners of the Blender o Cleaned Label Present o Rectangular Lid |
o Butterfly Valve
o Top Closing Lid o Shaft & Baffles o Gasket Integrity |
||||||
| Vibro Sifter | Equipment ID No.: _____________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| Stage areas / Equipment Name | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||||
| Vibro Sifter | CLEANLINESS OF
o Feed Hopper o Sieve Integrity o Gasket Integrity o Cleaned Label Present |
o Intermediate Hopper
o Discharge Chute o Wheels |
|||||||
| Tippler | Equipment ID No.: ____________________
o Ensure the absence of batch documents, labels, materials, traces of water or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, Powder or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||||
| CLEANLINESS OF
o Stand o Cleaned Label Present |
o Cone
o Valve o Gasket integrity |
||||||||
| Vacuum cleaner | Equipment ID No.: ____________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o Area surrounding the Equipment |
||||||||
| CLEANLINESS OF
o Hose Pipe o Dust resisting filter |
o Dust Collecting Bag
o Cleaned Label Present |
||||||||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
||||||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
| COMPRESSION [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||
| Compression
Cubicle |
Room ID: _____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] o Differential Pressure [10 – 26 Pascal] |
||||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container o Tools o Waste Bins o Light Fixtures |
o Area under compression Machine
o Area under the Deduster o Area under the Metal Detector o Area under the balances o Supply air Grills o Return air Grills o Vacuum cleaner |
||||||
| Compression Machine | Equipment ID No.:_________________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
||||||
| CLEANLINESS OF
o All acrylic component integrity (intact) o Machine interior & hose pipes o Lower & Upper punch holes |
|||||||
| o Sleeve of the hopper
o Forced Feeder assembly o Pressure Rollers o Discharge Chute o Lower & Upper cam tracks |
o Hopper
o Turret o Die Cavities o Cleaned label present o Safety Guard |
||||||
| Dust Extractor | Equipment ID No.: ____________________
o Ensure the absence of powder. |
||||||
| CLEANLINESS OF
o Hose Pipe o Dust Collecting SS pipe o 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.: ________________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part. q Area surrounding the Equipment |
||||||||||
| CLEANLINESS OF
q Chute assembly q Cleaned label present |
q Rejection Flap
q Rejection Container q Solenoid cover |
||||||||||
| Deduster | Equipment ID No._____________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o Ensure the absence of batch documents, labels, materials, powder, tablets or remnants of previous product or batch & traces of water on each dismantle part. o Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part. q Area surrounding the Equipment |
||||||||||
| CLEANLINESS OF
q Perforated Plate |
q Discharge Chute
q Cleaned Label present |
||||||||||
| Vacuum cleaner | Equipment ID No.: ____________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o Area surrounding the Equipment |
||||||||||
| CLEANLINESS OF
o Hose Pipe o Dust resisting filter |
o Dust Collecting Bag
o Cleaned Label Present |
||||||||||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
||||||||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||||
| COATING [Released / Not Released / Hold / Rejected / Not Applicable] | ||||||||
| Coating Room | Room ID No.: ____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] q Differential Pressure [10 – 26 Pascal] |
|||||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container o Tools o Waste Bins o Light Fixtures |
o Area under coating Machine
o Area under the Colloidal mill o Area under the coating solution preparation tank o Area under the coating solution storage tank o Area under the balance o Supply air Grills o Return air Grills |
|||||||
| Auto-coater | Equipment ID No.: ________________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch. o 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. o Ensure the absence of materials, Powder, tablets or remnants of previous product or batch & traces of water on each critical part. o Area surrounding the Equipment |
|||||||
| CLEANLINESS OF
o Exhaust hood o Base of the Dosing Pump o Cleaned Label Present o Connecting Pipes o View Glass Integrity (intact) o Temperature probe o Sampling Probe o Light assembly |
o Hot air blower
o Spray Guns o Baffles o Cabinet o Pan o Spray gun Bar o PLC assembly o Peristaltic Pump |
|||||||
| Colloid Mill | Equipment ID No.: ________________________
o Ensure the absence of batch documents, labels, powder, tablets, materials or remnants of previous product or batch and traces of water or colour. |
|||||||
| Stage areas / Equipment Name | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
|||||
| Colloid Mill | CLEANLINESS OF
o Cleaned Label Present o Rotor |
o Hopper
o Hose pipe o Stator |
||||||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
|||||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||||||
| INSPECTION [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||||||
| Inspection Area | Room ID No.: ____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] q Differential Pressure [10 – 26 Pascal] |
||||||||||
| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container o Light Fixtures |
o Tools
o Waste Bins o Supply air Grills o Return air Grills o Area under Inspection Machine o Area under the balance |
||||||||||
| Inspection Machine | Equipment ID No.: ______________________
o 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
o Base of the belt o Illumination of the belt o Cleaned label present o Reject tray o Integrity of rollers |
o Conveyor belt
o Hopper o Tablet modifier o Inside the belt o Rollers |
||||||||||
| Manual Inspection | Room ID No.: ____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] o Differential Pressure [10 – 26 Pascal] o SS trays o Inspection Table |
||||||||||
| Weighing Balances | Instrument ID No.: ____________________
CLEANLINESS OF |
||||||||||
| o Balance Platform
o Balance display |
o Balances are Calibrated
o 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 by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
||||
| PACKING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||||
| Packing Room | Room ID No.: ____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board o Temperature [24 ± 2°c] o Relative Humidity [35 – 50 %] q Differential Pressure [10 – 26 Pascal] |
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| CLEANLINESS OF
o Floor o Walls o Ceiling o Drain o Container |
o Light Fixtures
o Tools o Waste Bins o Supply air Grills o Return air Grills o Area under packing Machine |
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| 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. o Pass box cleanliness. o Overprinting Stereos of previous batch or product are destroyed. o Area surrounding the Equipment |
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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 / Equipment Name | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
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| PACKING [Released / Not Released / Hold / Rejected / Not Applicable] | |||||
| Packing Line | Line No.: ____________________
o Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch. o Ensure ‘CLEANED’ label is affixed on each equipment. o Ensure updation of Status Board |
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| Stage areas / Equipment Name | Checks | Checked by
Production Date & Time |
Counter checked By Quality Assurance
Date & Time |
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| Packing Line | CLEANLINESS OF | |||||||
| o Floor
o Walls o Ceiling o Container o Carets |
o Tools
o Waste Bins o Supply air Grills o Return air Grills o Light Fixtures |
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| Conveyer Belt | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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| Cartooning Machine | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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| Online check weigher | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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| Shipper sealing machine | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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| Shipper weighing balance | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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| Shipper strapping machine | Equipment ID No.: ________________________
o Ensure the absence of batch documents / labels / Tablets / Powder / Strips / Blisters / secondary packing materials or remnants of previous product or batch. o Area surrounding the Equipment |
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Note: Mark ‘√’ if complies & mark ‘X’ if does not comply during line clearance.
Stage areas / Equipment Name: Manual Coding Room
Checks
Ensure the absence of batch documents, labels, materials, or remnants of previous products or batches.
Ensure the ‘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 comply during line clearance.
Stage areas / Equipment Name –Packing
Checks
o Approval of Intermediate product of current batch.
o BMR of current batch completed up to the previous stage.
o Machine operation clearance.
![[ays_quiz id='19']](https://pharmaguidances.com/wp-content/uploads/2023/08/quiz.jpg "Quality Assurance (QA) Quiz No.1 3")