- OBJECTIVE :To ensure quality of Finished Products during strip packing and final packing operation of tablets.
- SCOPE:This SOP shall be applicable in-process controls during primary and secondary packing operation of tablets.
- RESPONSIBILITY : In process Quality Assurance Officer / Executive shall be responsible for follow the procedure mentioned in this SOP
- ACCOUNTABILITY: Head Quality Assurance shall be accountable for compliance of this SOP.
- START UP
- Inspect the following areas as per SOP for line clearances
- (A) Primary packing area:
- a) sealing machine; its hopper; feed frame and its surroundings.
- (B) Secondary packing area:
- a) packing belt and surroundings.
- b) shipper sealing and coding machine
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- (C) Bottle packing room in case tablets are to be packed in bottles.
- Check the details of Packaging Operation indicated on the display board, adjacent to the packaging line with the Batch details mentioned in BPR and ensure that the Product and Packaging Materials belong to batch to be packed.
- Ensure that the Bulk Product is released for packing by Quality Control and entries in BMR are completed up to the last operational stage and BPR is up to date with respect to dispensing and receipt of packaging materials etc.
- Ensure that the packing components on the line are as per Bill of Packaging Materials.
- Verify the over printing details (having checked by Production Executive) on the specimen of plain aluminum foil, on set of blank strips of one cut , on cartons and shipper label. Attach these specimens after approval in the BPR.
- If any abnormalities is observed in the over printed detail/ in its legibility on any of the specimen of plain aluminum foil,on set of blank strips and /or on cartons, ask the production operator to correct the same and ensure for the correct,clear and legible overprinting.
- Verify that production executive has completed all the entries of line clearance in batch packing record.
- Verify compliance of the all points of line clearance check list and on being satisfied make the entries of line clearance in batch packing record and allow to start packing operation.
- INPROCESS CHECKS DURING STRIP/BLISTER PACKAGING OPERATIONS:
- Ensure the overprinted batch details of the strips, cartons and shippers. Ensure that they match with the details given in the BPR.
- Ensure that leak test is passed or not. If passed allow to continuing the packing. If fail re-set the machine until the leak test will pass.
- Ensure that RH, temperature and pressure differential of strip/blister packing room is within specified limit.
- Inspect the in-process packing parameters on few initial packs ,if satisfactory, allow further online packing.
- Inspect the in-process packing parameters at frequency specified on BPR for –
- Coding details on strips/blisters, unit cartons/catch cover and shipper.
- Quantity of tablets in strips/blisters; strips/blisters in cartons and cartons in shippers
- Pack inserts like literature etc. and their arrangement.
- Sealing of strip/blister’s corners and cutting.
- Visible defects in strips like cut pockets, missing pockets in strips and smudging of overprinting on carton / shippers/ strips etc.
- Leak test of strips / blisters produced in one complete rotation of forming roller at the start of batch.(taken from one cut at the machine).
- Ensure that all the parameters checked are found within specified limit. Record the observation in BPR at specified table.
- Ensure that the set temperature of both sealing forming rollers is maintained during strip packing and observations of the temperature are recorded by operator in BPR in respective table.
- Ensure that a length of printed foil from each joint in a roll is kept as specimen and evidence along with approved specimen in BPR. In case, the packaging material like cartons, leaflets and printed / plain aluminum foil are more than one A.R.No., attach a representative sample of each to the BPR.
- If any pocket fails in leak test, hold the strip packing operation immediately.
- Withdraw sample from the cartons, packed in between the duration of present and previous leak test and perform leak test again on double of the quantity of the strips. None of the pocket should fail in leak test.
- If repeat leak test fails reject the strips packed in duration under question and ask production executive / officer to keep these strips for recovery of the tablets with proper identification.
- Withdraw control sample so as to represent start, middle and end of the strip packing from the running line and keep in cartons before transferring them in control sample room.
- After completion of the packing ensure that stereos of the batch are destroyed and details of destruction are recorded in BPR.
- After completion of the packing operation ensure that extra packing material is returned after being recorded on sheet of Excess Return Note.
- Verify the quantity and the A.R. No. of the material remained unused for packing before signing of clearance for return of extra packaging material back to stores.
- Check and verify the reconciliation of the packaging material and ensure that variance is within limit as specified in BPR.
- CLEARANCE FOR TRANSFER OF PACKED FINISHED PRODUCTS:
- Ensure that the Finished goods transfer note of each product is prepared by the Production Officer / Executive.
- Check and ensure that the BMR & BPR is complete in all respects and contain duly signed documents up to the stage of transfer.
- Ensure that any defects reported during In process checks are rectified and corrective action is recorded by Production Officer / Executive.
- Count the total number of shippers ready for transfer and crosscheck the total quantity in shippers with the quantity mentioned on Finished Goods Transfer Note.
- Ensure that control and / or stability samples (If required) are collected and recorded in BPR.
- After verification of all above points allow transferring the material to Bonded Storage Room (BSR)
- FORMS AND RECORDS
- Not Applicable
- Master Copy – Quality Assurance
- Controlled Copies – Quality Control, Quality Assurance, Production
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Date Revision Number
Reason for Revision
– 00 New SOP
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube