Following are the guidelines for pharmaceutical process check during offline and online packing.
1. Take line clearance of the packing line as per SOP and record the same in sequential record.
2. Transfer the entire batch to the stripping/blistering section after weighing and proper entry in the BMR.
3. Take overprinting machine line clearance as per SOP.
4. Take Machine line clearance as per SOP.
6. Check and verify the printing details overprinted on Aluminum foil, Cartons and Shipper label with QA supervisor.
7. Perform the leak seal test As mentioned in the SOP and maintain the hourly entry in the BMR.
8. Check and record Sealing roller /plate temperature, Forming plate temperature, temperature and relative humidity of the machine cubicles on the hourly basis in BMR.
9. Take 5-show boxes/10 bricks/3 shipper for checking purpose on the hourly basis and record the reading in BMR.
9.1. Check strips for identification, empty pockets, broken tablets, improper sealing, punctured pocket, dirty strips, and defective printing, missing text, and overprinting details
9.2. Check Show boxes for dirty, torn, defective show boxes.
9.3. Check the show boxes for defective printing and text missing.
9.4. Check the show boxes for overprinted details.
9.5. Check the insert for wrong and missing inserts.
9.6. Check the 5 ply outer for dirty, moist or torn condition.
9.7. Check the correctness of shipper label for the overprinted detail affix one label on the area provided on shipper and insert a copy of the same in the shipper.
10. If any defect found while the process is going on then immediately stop the process rectify the problems check all the packed goods of last one hour.
11. Restart the packing operation after rectifying the problem and perform all the in-process checks.
13. After packing reconcile all the packing material and record the same in BMR.
14. Return all the excess packing material to PM stores as per SOP for return of Packing and Raw Materials.
15. Transfer the packed goods to BSR after getting approval from QA.
1. Take line clearance of the packing line as per SOP and record the same in sequential record.
2. Transfer the entire batch to the stripping/blistering section after weighing and proper entry in the BMR.
3. Take overprinting machine line clearance as per SOP.
4. Take Machine line clearance as per SOP.
6. Check and verify the printing details overprinted on Aluminum foil, Cartons and Shipper label with QA supervisor.
7. Perform the leak seal test As mentioned in the SOP and maintain the hourly entry in the BMR.
8. Check and record Sealing roller /plate temperature, Forming plate temperature, temperature and relative humidity of the machine cubicles on the hourly basis in BMR.
9. Take 5-show boxes/10 bricks/3 shipper for checking purpose on the hourly basis and record the reading in BMR.
9.1. Check strips for identification, empty pockets, broken tablets, improper sealing, punctured pocket, dirty strips, and defective printing, missing text, and overprinting details
9.2. Check Show boxes for dirty, torn, defective show boxes.
9.3. Check the show boxes for defective printing and text missing.
9.4. Check the show boxes for overprinted details.
9.5. Check the insert for wrong and missing inserts.
9.6. Check the 5 ply outer for dirty, moist or torn condition.
9.7. Check the correctness of shipper label for the overprinted detail affix one label on the area provided on shipper and insert a copy of the same in the shipper.
10. If any defect found while the process is going on then immediately stop the process rectify the problems check all the packed goods of last one hour.
11. Restart the packing operation after rectifying the problem and perform all the in-process checks.
13. After packing reconcile all the packing material and record the same in BMR.
14. Return all the excess packing material to PM stores as per SOP for return of Packing and Raw Materials.
15. Transfer the packed goods to BSR after getting approval from QA.
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