Table of Contents
1.0 OBJECTIVE:
1.1 To lay down the Procedure for In-process checks during packing.
2.0 SCOPE:
2.1 This SOP is applicable for In-process checks during packing of all products in production department.
3.0 RESPONSIBILITY:
3.1 Officer-Packing
3.2 IPQA-person
3.3 Officer-QA
4.0 ACCOUNTABILITY:
4.1 Head-QA
4.2 Manager-Production
5.0 PROCEDURE:
5.1 Inspection of Packaging Materials:
5.1.1 Production Officer shall check the packaging components issued from store as per the batch packing record and IPQA person also verify all the components to ensure quantity and quality of packing material which are approved by Quality Control.
5.1.2 IPQA person 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).
5.2 In-process Checks during Blister Packing Operation:
5.2.1 IPQA-person 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.
5.2.2 IPQA-person shall ensure that the ‘Product status Label’ is labelled and displayed on the machine.
5.2.3 IPQA-person 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.
5.2.4 Production Officer shall check the clarity of the printed/coded/embossed details on the foil, as per there requirement with respect to Batch No., expiry date, MRP etc., if the coding/printing is correct IPQA-person and Production Officer shall sign on printed/coded foil and attach the signed foil to the BPR.
5.2.5 Production Officer and IPQA-person 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 in the machine.
5.2.6 IPQA-person and Production officer shall independently inspect continuous blister packs as per leak test SOP.
5.2.7 Production packing officer shall checks during Blister/Bulk Packing Operation as following check points:
5.2.7.1 Coding /printing details
5.2.7.2 Knurling on blisters
5.2.7.3 Blister formation
5.2.7.4 Cutting edges of blisters
5.2.7.5 Punctured pockets In-Process Checks
5.2.7.6 Ink lifting on foils In-Process Checks
5.2.7.7 Scratch marks and spots on strips In-Process Checks
5.2.7.8 Chipped/capped/broken tablets In-Process Checks
5.2.7.9 Defective tablets / capsules In-Process Checks
5.3 In-process Checks during Blister strip:
5.3.1 IPQA-person shall ensure that the details of the Packaging Operation on-line is written and displayed on the board adjacent to the line.
5.3.2 IPQA-person and Production Officer shall check that the coding/printing details entered on the blister foils match with the details entered on other coded/printed materials such as cartons, shipper labels etc., and with the details on the BPR.
5.3.3 IPQA-person and Production officer shall independently inspect the first few packed units on-line and then at regular intervals till completion of the batch.
5.3.4 Following check points are to be checked.
5.4 Any Visible Defects on Strips/Blister.
5.4.1 Coding details on unit cartons, outer cartons, shipper labels etc.
5.4.2 Quantity in unit cartons and outer cartons.
5.4.3 Arrangement is compact without any gaps or rattling
5.4.4 Packaging components including pads, partitions, literature etc., and their arrangement. (whichever is applicable)
5.4.5 Sealing of polybags (if applicable).
5.4.6 Placing of desiccants (if any).
5.4.7 Irregular labelling on unit cartons and shippers.
5.4.8 Ensure that the rejected strips are stored in suitable containers, in specified storage conditions and labelled with batch details.
5.4.9 In case blister packing and secondary packing operations are done simultaneously, both the activities shall be monitored by single inspection.
5.5 In-process checks during Bulk packing of Tablets / Capsules / Bottles: (If available)
5.5.1 IPQA-person 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.
5.5.2 IPQA-person shall ensure that the ‘Product status Label’ is filled and displayed on the machine.
5.5.3 IPQA-person shall ensure that the temperature and relative humidity of the bulk packing room is in accordance to the manufacturing instructions, if any, on the BPR.
5.5.4 Ensure cleanliness of empty containers for absence of dust, any denting, colour, black spots or any extraneous matter.
5.5.5 IPQA-person and Production Officer shall independently inspect 2 to 5 bottles at 1 hour interval.
5.5.6 Coded /printed details on the label of bottles
5.5.7 Packing components like cotton coil, desiccant, literature, etc.
5.5.8 Quantity of tablets/capsules by weight and by count.
5.5.9 Defective Tablets/Capsules.
5.5.9.1 IPQA-person and Production Officer shall check for the clarity of the coded/ embossed/printed details on the bottle label, as per the requirement with respect to Batch No., expiry date etc., If the coding/printing is correct IPQA-persons and Production Officer shall sign on coded/printed label and attach the signed label to the BPR.
5.5.9.2 Production Officer and IPQA-person 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 made on the machine.
5.5.9.3 In case any defect or discrepancy is observed, IPQA-person shall inform the Production Head or Packing Head and ensure that the defect is rectified.
5.5.10 After an observed defect is rectified, Officer-QA shall ensure that packed units collected before the defect was observed and after the defect is rectified, are free from defects.
5.5.11 Officer-QA 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 BPR.
5.5.12 Blister/Bulk packing operation’ shall be filled in the corresponding Batch Production Record.
6.0 ABBREVIATION:
6.1 SOP : Standard Operating Procedure.
6.2 QA : Quality Assurance.
6.3 QC : Quality Control
6.4 BPR : Batch Packing Record
6.5 PD : Production
6.6 IPQA : In-process Quality Assurance