Drug Product Packing – Guideline and SOP

Standard Operating Procedure (SOP/Guideline) for Packing of Drug Product. General rules to be adopted in the packing section for maintaining product identity, eliminating the potential mix-ups, handling of rejection, and smooth operation of the packing department.

Guideline for Drug Product Packing

1.0   PURPOSE:

    • The purpose of this SOP is to lay down general rules (to be adopted in the packing section for maintaining product identity, eliminating the potential mix-ups, handling of rejection and smooth operation of the drug product packing department.

2.0   SCOPE:

    • To prevent errors at the packing stage of drug products like bulk tablets/capsules into final packs.
    • Prevent mislabelling & cross-contamination during drug product packing.
    • To ensure the use of correct labels, labeling, and packing materials for each product.

3.0   REFERENCES:

    • In HousePacking of Drug Product
    • SOP for IPQC during packaging Operation
    • SOP for Handling and Usage of residual Recovery
    • Handling and destruction of Nonrecoverable recovery SOP.
    • SOP for Procurement, Handling, and destruction of rubber stereos
    • Return of Leftover packing material SOP.

4.0   RESPONSIBILITY – GUIDELINE OF DRUG PRODUCT PACKING:

    • Production person shall be responsible for-

    • To set and run the line with proper segregation of good products, packing material, and rejections.
    • Do proper labeling on the machine and line.
    • Ensure the use of correct packing material during the operation.
    • Ensure the use of correct labeling being used during the packing operation.
    • To do the in-process checks during the packing operation
    • To enter all details and checks in BPR and other log cards.
    • Collect the rejection generated in different stages of packing operation as per standard instructions.
    • To document the rejection generated in the respective documents.
    • Reconciling the packing materials at the end of the packing.
    • The quality assurance shall be responsible for-

    • Check and verify the proper segregation of good products, packing material, and rejections.
    • To counter check the proper labeling and the in-process checks.
    • Verify the documentation of rejection quantity in the respective documents.
    • Verify the reconciliation of packing materials at the end of batch.
    • Review and approve the SOP.

5.0   ABBREVIATIONS USED IN GUIDELINE FOR DRUG PRODUCT PACKING:

    • BMR: Batch Manufacturing Record
    • BPR: Batch Packing Record
    • PMS: Packing Material stores
    • MIO: Material Issue Order

6.0   PROCEDURE – GUIDELINE FOR DRUG PRODUCT PACKING:

    • Precaution during drug product packing:

    • Use safety hand gloves, mask during handling of the product.
    • Use proper gauging procedures during working in the primary area.
    • Ensure that, all accessories used for operation are clean.
    • General Instruction – Guideline for Drug Product Packing :

    • Take line clearance of all the respective equipment and accessories involved in the operation.
    • Check the product/ Batch as per BMR/ BPR and respective packing material with appropriate MRO.
    • Transfer the primary packing material and check and confirm the details of individual items against confirmed MRO.
    • Tally the individual container for product name, batch no. gross weight and quantity against BMR or quantity required for packing ( BPR) and transfer the same in the primary packing cubicle.
    • Arrange secondary and tertiary packing material in the secondary packing area in the respective line by verifying packing material qty. against MRO.
    • Pack and store only one product at a time on any one packing line.
    • Segregate the finished products and packing materials in the packing area of drug product by a physical barrier or adequate special separation to minimize mix-ups.
    • After line clearance, issue the required stereos to the Operator for setting stereos on the machine.
    • In case of a pouch filling machine, feed the correct batch details on the printer and take proof of the details on the foil.
    • In the secondary packing area, delete all the previous batch details from the printer and newly set the batch details, which batch going to pack on line.
    • Set the machine and confirm the setting of all the machines prior to run.
    • Set the “NFD or CAMERA” on which NFD and CAMERA are available.

    • Collect overprinting proofs from the primary area as well as the secondary area ( i.e. foil proof and Show box overprinting proof) .overprinting proofs to be checked by line officer against BPR, MRO, BMR, and stereos order/receipt details.
    • The same proves to counter checked by another packing officer and QA officer and documented the same in BPR.
    • Collect overprinting show box challenge test proofs by saving the batch details and collect the proof by restarting the condot overprinting system.
    • Check the overprinting proofs against first Showbox proof and BPR, MRO, BMR, and stereos order/receipt details.
    • The same proves to counterchecked by another packing officer and QA officer and documented the same in BPR.
    • Once all the challenge tests found satisfactory, start the packing line.
    • Set the ITW shipper weighing balance as per respective SOP and enter the net weight limit in the BPR.
    • Attach the proof of first shipper duly checked and signed by, packing officer, counter checked by another packing officer and QA officer.
    • Carry out in-process checks at the regular intervals specified in BPR and respective SOP.
    • Management of Rejection handling containers – Drug Product Packing:

Sr. No. Container Area Place Type Remark
1. Red Primary Under NFD/Camera rejection outlet Initial and intermediate rejection during setting and operation To be defoiled and sorted
2. Grey Primary Overflow outlet/ collection of good strips/ blisters During operation  excess collection To be checked and packed
3. Small Red Primary  Used after defoiling and sorting Defoiled rejected/ non- recoverable and handling loss tablets/ capsules collection To be destroyed
4. Small Grey Primary Used after defoiling Used to collect defoiled tablets/ capsules collection To be sorted

 

Sr. No. Container Area Place Type Remark
5. Blue Primary Used after sorting Store sorted tablets/ capsules collection. Used after approval by packing and QA officer
6. Grey Secondary Overflow outlet/ collection of good strips/ blisters During excess strips/ blister collection during operation To be checked and packed
7. Grey Secondary Under check weigher rejection outlet During rejected show box  collection during operation To be checked and packed
8. Red Secondary Near show box packing in shipper ( Final Packer) During printing/ overprinting rejected show box  collection during operation Show box to be replaced.

 

    • Rejection generated during packing of drug production primary ( Strip/ Blister/ pouch):

    • Types of rejection generated during Blister / Strip/ pouch packing operation in the Primary area.
Sr. No. Type of rejection
1 Initial machine setting
2 Overprinting/Embossing rejects
3 Printing rejects
4 Non filled pack rejects
5 Product defect rejects -like powder in the pocket, broken product, etc.
6 Forming rejects

 

Sr. No. Type of rejection
7 Foil cut /Torn pocket
8 Pack size defect
9 Dry ink rejection
10 Foil rejects
11 Sealing rejects
12 Less or excess fill value
    • Initial Machine Setting – Drug Product Packing :

    • Reject all the defected strips/ blisters generated during the machine setting stage to be checked for any tablet/capsule and place them in a “yellow color” polybag with a status label.
    • Reject all the defected strips/ blisters generated during fine setting machine at setting stage/ operation in ‘Red’ crate with the status label.
    • All the strips/ Blister are defoiled and collected in ‘Grey’ crate, for further activity e. sorting.
    • Overprinting / Embossing rejects/ dry ink rejection – Drug Product Packing:

    • The overprinting rejection is collected in the ‘Red’ crate with the status label, rejected strips/ blisters, to be defiled.
    • All the strips/ Blister are defoiled and collected in ‘Grey’ crate, for further activity i.e. sorting.
    • Printing Rejection/ Foil rejection/ foil joint – Drug Product Packing:

    • During stripping/ blistering if you found any printed rejection such as any character missing, change in printing matter, ink spread, shade variation , foil joint, then collect all the strips/ blisters as a rejection in ‘Red’ carte.
    • Stop the line immediately, and intimate to your officer or shopfloor in charge.
    • If required, check the previous shippers for such defect, and collect all the rejected strips/ blisters in ‘Red’ crate.
    • Check the roll / A.R. no of a particular item failing for such defect. If yes, then carry out online rejection as per particular SOP.
    • If the such defected quantity is very less ( Small quantity for particular roll), then, reject the particular quantity by defacing / destruction and mention the same in BPR.
    • Such rejected strips/ blisters are defoiled and tablets/ capsules are collected in ’Grey’ crate with proper status label.
    • During Aluminium foil roll change, keep the track empty ( Free from tablets/ capsules) between feeding channel to sealing plate/ roller. Place the aluminum foil and affix on the PVC/PVDC with blue tape.
    • All the empty blisters generated during foil change treat as ‘Rejects’.
    • Non filled pack rejects – Drug Product Packing:

    • During stripping,/ blistering non-filled rejection generated during operation after scanning of NFD or camera is collected in ‘Red’ crate with the proper status label.
    • All the strips/ Blister are defoiled and collected in ‘Grey’ crate, for further activity i.e. sorting.
    • Product defect rejects – – Drug Product Packing:

    • During operation, if we observed any defect in the products such as broken tablets, improper size of the tablet, excess powder in the product, improper size of capsules, etc., stop the line.
    • Intimate to the concerned officer, department head, and QA for further action.
    • Collect the rejected strips/ blisters in the red crate as rejection.
    • Defoiled the tablets/capsules and carry out further activity as per instruction given by Dept. head/ designee/ QA.
    • Forming Rejection/ sealing rejection – Drug Product Packing:

    • During the packing of the drug product, if we observed any forming rejection and/or sealing rejection due to certain reasons such as improper setting, change parts issue, improper utility, then stop the machine.
    • Rectify the observed problem.
    • When strip machine is stopped due to certain reason and the strip between the sealing roller is considered as reject.
    • Collect the rejected strips/ blisters/ web if any on the machine.
    • Collect all the rejection in the ‘Red’ crate with proper status label.
    • Check the tablets/ capsules for any defect, if we observed any defect such as broken tablets, defected capsules then transfer all the tablets/ capsules in ‘Red’ drum/ crate as a ‘non-recoverable’ for destruction.
    • Foil cut/ torn pocket/ pack size defect – Drug Product Packing:

    • During packing of drug product, if we observed any foil cut/ torn pockets or pack size defect due to machine setting, change parts issue or any other technical problems, then stop the machine.
    • Collect all the rejection in the ‘red’ carte with proper status label.
    • Rectify the machine problem.
    • Defoiled the tablets/ capsules and collect in the ‘Gray’ crate with proper status label.
    • Less fill value/ excess fill value- Drug Product Packing:

    • During pouch filling machine operation, if we observed any less fill value/ excess fill value in the pouch, stop the machine.
    • Collect the all pouch as rejection.
    • Counter-weight the fill value of collected samples., if we observed the fill value is within the limit, then transfer for packing.
    • If you found, the fill value is less or more than the limit, then treat as rejection.
    • Collect all the rejection in the ‘Red’ crate with proper status label
    • All the defoiled tablets collected in the ‘Grey’ crate is sorted physically for any defect such as broken tablets, pilling, improper shape and size.
    • Collect good tablets/ capsules in the ‘Blue’ crate with a status label, sorted good tablets/ capsules to be used.
    • Collect rejected tablets/ capsules in ‘red’ small crate and treat them as non-recoverable.
    • After checking, verification, and certification for use of sorted tablets/ capsules quality by production officer/ QA officer, use these tablets/ capsules for packing.
    • Enter good sorted tablets/ capsules quantity in BPR, duly signed by production officer and QA.
    • Enter the shipper number in which these sorted tablets/ capsules used for packing in BPR.
    • All the tablets/ capsules fallen on the floor is treated as non- recoverable by considering as handling loss.
    • At the end of the batch, all the non-recoverable is weighed in the presence of a production officer and QA.
    • Enter the weight of non- recoverable in BRP.
    • Rejection generated during packing in primary (Bottle packing)- Drug Product Packing:

    • During machine setting and intermediate machine, the setting is collected in ‘Red’ crate and treats as rejection.
    • The rejection generated during bottle handling, cap handing, and inspection is collected in ‘Red’ carte and treat as ‘Rejects’.
    • During operation, if we observed, low fill value or high fill vale, then stop the machine
    • Collect the bottles filled bottles from the line and collect the powder in the polybag in ‘Red’ crate as non- recoverable.
    • Set the machine and verify the fill weigh, If we found the fill weight is within the specified limit, then run the machine.
    • If we found any rejection during capping operation, collect the rejection in ‘Red’ carte as non-recoverable.
    • If we found any bottle rejection after or during induction sealing due to cross capping,  over or less heating, absence of wad, improper sealing, collected in ‘Red’ crate, and treat as non- recoverable.
    • Collect all the bottles from the different ‘Red’ crates.
    • Collect the powder in the ‘red’ crate having a double polybag.
    • Weight the powder and verified by production officer and QA officer and treat as Non-recoverable.
    • Make the enter of qty. in BPR, duly signed by production officer and QA.
    • Rejection generated in the secondary area – Drug Product Packing:

    • Prior to run the line, check the ‘Gray’ crates are kept at the end of conveyor belt/ overflow blisters/ strips collection chute with the proper status label.
    • Check another ’Gray’ crate is available to collect check-weigher rejection, below the Check-weigher rejection box.
    • ‘Red’ crate is available near the overprinting checker after the check-weigher for collection of ‘Printing and Over-printing’ rejection
    • Check during line setting and operation, strips, blisters, bottles, pouches for overprinting as well as quality.
    • Send the rejected strips/ Blisters/ pouches/ bottles in the primary area for further action.
    • During packing, Collect the excessive strips/ blisters/ pouches/ bottles in the ‘Gray’ crate with the proper status label.
    • Collect the rejected ‘Show Box’ in the ‘Red’ crate for destruction.
    • The check weighers rejection, which is generated during passing the show box through check-weigher for less and excess weight are collected in the ‘Gray’ carte.
    • Collect the show box rejection generated due to overprinting in the ‘Red’ carte with proper status labeling.
    • At the end of the shift/End of the batch/whenever required, Check the collected strips/ blisters/pouches/bottles for any defect and packed in a Show box.
    • Check the Check-weigher rejection show box/ bottles for quantity and quality of show box/ bottle label and passed through check weigher.
    • Pass through check weighed these rechecked Show box/ bottles and packed.
    • Destroy the overprinting and printing ‘Rejected Show Box’ and strips/ Blisters/ pouch and packed in a fresh show box.
    • In case of bottles, remove the label, re-pass through labeling machine for relabeling.
    • All the show boxes/ bottles are overprinted and passed through check weigher.

    • After checking the overprinting quality, Pack these Showbox.
    • Send the rejection strips/ blisters/ pouch/ bottles to the primary area for further action.
    • Destroy the rejection Show box/ leaflets/shippers and excess packing material and send it to the scrape area.
    • Document the rejected quantity after checked by the production officer and verified by QA.
    • Reject the Inner shippers/shippers during handling or any other reason, discard the shipper, and at the end of the batch enter the rejected quantity in the BPR.
    • In case of any reason, rejected shipper labels during operation, tare the labels, and enter the quantity of rejected labels in BPR.
    • Note:

    • If you found any new type of rejection during operation, stop the line immediately and intimate to the Packing officer, Department head, QA and carry out the further activity as per instruction given by them.
    • Destroy the used and unused stereos on completion of a batch as per SOP of Procurement, handling, and destruction of rubber stereo.
    • Collect and handle the recoverable recovery and non-recoverable recovery as per respective SOP.
    • Destroy the leftover printed packing material on completion of batch/ product as per SOP of “Destruction of Packing waste generated during packing Operation” and reconcile the same in BPR.
    • Return leftover unprinted packing material, with the status label to the PMS as per SOP of “Return of Leftover Packing Material”.
    • While returning the rejected material, affix rejected labels to the material after checking by QA and make necessary entries in the ERP system.
    • Reconcile the packing material in BPR
    • Check the BPR for correct completion of all documentation pertaining to the packing, process before submitting it to QA.
    • Transfer the packed goods to BSR Finished Goods after completion of shipper weighing with QA approval.

pharmabeginers

Niranjan Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an updated pharmaceutical blogging platform. Email: [email protected]

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