- OBJECTIVE :
- To lay down the procedure for in-process checks during the packaging operation of tablets and capsules.
- RESPONSIBILITY :
- Officer-Production Packaging.
- Head of Production Department.
- Officer-Quality Assurance
- Head of Quality Assurance Department to ensure compliance.
- PROCEDURE
- Inspection of Packaging Materials :
- The production Officer and QA-Officer shall check that the packaging components issued (containers, closures, foils, etc.,) are as per the Production Order – Packaging Materials and also check that materials issued are approved by Quality Control.
- QA-Officer along with Production Packaging Officer shall check the printed text matter on all printed components as per requirement and attach a specimen of the printed component to the respective Batch Production Record (BPR).
- In-process Checks during Blister Packing Operation :
- QA-Officer shall ensure that the correct product of a specific Batch No. of tablets/capsules is brought to the blister packing room and is approved by Quality Control.
- QA-Officer shall ensure that the ‘Product Label’ (annexure -1) is filled and displayed on the machine.
- QA – Officer shall ensure that the temperature and relative humidity of the blister packing room is in accordance with the manufacturing instructions, if any, on the BPR.
- QA Officer and Production Officer shall check for the clarity of the coded/embossed details on the foil, as per the requirement with respect to Batch No., expiry date, etc., If the coding is correct QA Officer and Production Officer shall sign on the coded foil and attach the signed foil to the BPR.
- Any printing on the tablet surface prior to packaging shall also be checked by QA Officer.
- The production Officer and QA Officer shall independently perform the Leak test on 10 continuous blister packs taken after the machine is set or after the machine is stopped and restarted or after any adjustments are made to the machine.
- QA Officer and Production officer shall independently inspect 10 continuous blister packs at about every 1-hour interval for the following and record the observations in the ‘In-process checks during Blister/Bulk Packing Operation’ (annexure-2)
- Coding details
- Knurling on blisters
- Blister formation
- Cutting edges of blisters
- Punctured pockets
- Ink lifting on foils
- Scratch marks and spots on strips
- Chipped/capped/broken tablets
- Defective tablets/capsules.
- Others
- In-process checks during the Packaging Operation of blister strips :
- QA-Officer shall ensure that the details of the Packaging Operation online are written and displayed on the board adjacent to the line.
- QA Officer and Production Officer shall check that the coding details entered on the blister foils match with the details entered on other coded materials such as cartons, shipper labels, etc., and with the details on the BPR.
- QA Officer and Production officer shall independently inspect the first few packed units online and then at regular intervals of one hour for :
- Any visible defects on strips.
- Coding details on unit cartons, outer cartons, shipper labels, etc.,
- Quantity in unit cartons and outer cartons.
- The arrangement is compact without any gaps or rattling
- Packaging components including pads, partitions, literature, etc., and their arrangement. (whichever is applicable)
- Sealing of polybags (if applicable).
- Placing of desiccants (if any).
- Irregular labeling on unit cartons and shippers.
- Ensure that the rejected strips are stored in suitable containers, in specified storage conditions, and labeled with batch details.
- In case blister packing and secondary packing operations are done simultaneously, both activities shall be monitored by a single inspection.
- In-process checks during Bulk Packing of tablets :
- QA-Officer shall ensure that the correct product of a specific Batch No. of tablets/capsules is brought to the Bulk packing room and is approved by Quality Control.
- QA-Officer shall ensure that the ‘Product Label’ (annexure -1) is filled and displayed on the machine.
- QA Officer shall ensure that the temperature and relative humidity of the bulk packing room is in accordance with the manufacturing instructions, if any, on the BPR.
- Ensure the cleanliness of empty containers for the absence of dust, any denting, color, black spots, or any extraneous matter.
- QA Officer and Production Officer shall independently inspect 2 to 5 bottles at 1-hour intervals for the following and record the observations in the ‘In-process checks during Blister/Bulk Packing operation’.
- Coded details on the label of bottles
- Packing components like cotton coil, desiccant, literature, etc.,
- Quantity of tablets/capsules by weight and by count.
- Defective tablets/capsules.
- QA Officer and Production Officer shall check for the clarity of the coded/ embossed details on the bottle label, as per the requirement with respect to Batch No., expiry date, etc., If the coding is correct QA Officer and Production Officer shall sign on the coded label and attach the signed label to the BPR.
- The production Officer and QA Officer shall independently perform the torque test on 2 to 5 containers taken after the machine is set or after the machine is stopped and restarted or after any adjustments are made to the machine.
- In case any defect or discrepancy is observed, QA-Officer shall inform the Production Officer and ensure that the defect is rectified.
- After an observed defect is rectified, QA Officer shall ensure that packed units collected before the defect was observed and after the defect is rectified, are free from defects.
- QA-Officer shall collect Finished Product samples, Reserve Samples, Stability Samples, and samples for Bio-availability studies whenever required of packed products as per the respective SOPs and enter the quantities respectively on the “In-process Checks during Blister/Bulk Packing Operation”.
- After completion of the Packaging operation for a batch of tablets/capsules, the format of ‘In-process checks during Blister/Bulk packing operation’ shall be filed in the corresponding Batch Production Record.
- Forms and Records (Annexures)
- Specimen label of “Product Label” – Annexure 1.
- Specimen format of “In-process checks during Blister/Bulk Packing Operation” – Annexure 2
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control. engineering
-
Annexure – 1
PRODUCT LABEL
Product :
Batch No. :
Batch size. :
Stage :
Container No. :
Gross weight :
Tare weight :
Signature :
Net weight :
Date :
-
Annexure 2
IN-PROCESS CHECKS DURING BLISTER/BULK PACKING OPERATION
-
Product : Batch Size: Date : Batch No. : Pack : Note: 1. Enter ‘ if no defects observed. Give serial numbers for observed defects and explain overleaf. 2. Sample size per inspection: Blister Pack 10 Bulk Pack 2 to 5
TIME (Hrs.) DEFECTS OBSERVED ON Shipper Label Coding BOPP Taping No. of Units Packed
Others
Carton Coding Uniformity Availability of Literature
No. of units packed
Sealing of Polybags
Text & Colour
Others
Label Coding Missing Loose/Slanted Crimpled/Stained Text and color
Others
Container Coding Text and colour Punctures
Empty Pockets Cracked/Chipped/Dented Stains
Primary Foreign Matter Knurling/Blister formation Quantity (Unit/wt) Cotton/Desiccant/LiteratureOthers Content Capped/Chipped/Dented Abnormal odor Abnormal color/appearance Printing/Embossing and Others Checked by: QA (Sign.) Qty No. of defects Remarks :
Inspected observed
TORQUE TEST Time No. of bottles checked
Removal Torque (Inch. Pounds)
(Limit* : )
Passes/Fails Checked by Remarks * ____ mm & ___ mm closures – ___ to ___ inch pounds LEAK TEST FOR BLISTERS Time No. of Blisters Checked Checked by Remarks DEFECTS /DEVIATIONS OBSERVED S No. Observation Action taken Sign. (PDO) Finished product analysis Sampled by : Date : Reserve Samples Sampled by : Date : Stability Samples Sampled by : Date : Bio-availability Samples Sampled by : Date : FORMAT No.:
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