1.0 PURPOSE:
To lay down a procedure for action plan in case of in process check and challenge test failure.
2.0 SCOPE:
This procedure is applicable for action plan to be taken in case of in-process check and challenge test failure in production department of both injectable & OSD block at (Company name).
3.0 DEFINITIONS:
4.0 RESPONSIBILITY:
4.1 Production operator is responsible to follow the procedure.
4.2 Production officer/executive is responsible for execution of the procedure.
4.3 IPQA officer/executive is responsible for verification of the procedure.
4.4 Head – Production is responsible to ensure the compliance of the procedure.
5.0 PROCEDURE:
5.1 Action plan in case of failure of in-process checks/challenge test for blister packing camera:
5.1.1 During batch packing operation failure of In-process checks/challenge test for blister packing camera, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.1.2 Remove all blisters/strips which are on elevated conveyor belt.
5.1.3 Ensure that no packed blisters/strips should on packing line and blister pack machine.
5.1.4 Quarantine the all shipper packed between the previous in-process checks/challenge test passed.
5.1.5 Remove the blister/strips from cartons/mono-cartons of quarantine shippers.
5.1.6 Removed all blisters/strips should be checked visually for presence of product and physical appearance.
5.1.7 Pack good blisters/strips in cartons/mono-cartons. Same cartons/mono cartons shall be pack in shipper.
5.1.8 Defective packs shall be transferred to respective primary area for destruction.
5.1.9 Destroy the defective packs and its packing material.
5.1.10 Set the blister inspection camera as per respective SOP/BPR.
5.1.11 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.1.12 After compliance of in-process checks/challenge test start the packing activity.
5.2 Action plan in case of failure of in-process checks/challenge test for overprinting:
5.2.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.2.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.2.3 Check all overprinting packs visually for correctness of overprinted batch details in presence of IPQA officer.
5.2.4 Good overprinted packs should be packed in shippers. Defective packs shall be transferred to respective primary area for destruction.
5.2.5 Destroy the defective packs and its packing material.
5.2.6 Reset overprinting unit/machine and production officer should check overprinting batch details and its quality. Same shall be verified by IPQA officer.
5.2.7 After compliance of in-process checks/challenge test start the packing activity.
5.2.8 Destroy the all rejects and same should be recorded in batch packing record.
5.3 Action plan in case of failure of in-process checks/challenge test for checkweigher:
5.3.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.3.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.3.3 Ensure that the no carton should be on packing line.
5.3.4 Check all packed cartons/mono cartons for correct, weight in presence of IPQA officer.
5.3.5 Good cartons/mono cartons should be packed in shippers. Defective packs shall be transferred to respective primary area for destruction.
5.3.6 Destroy the defective packs and its packing material.
5.3.7 Reset the checkweigher for online weighing of cartons/mono cartons.
5.3.8 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.3.9 After compliance of in-process checks/challenge test start the packing activity.
5.3.10 Destroy the all rejects and same should be recorded in batch packing record.
5.4 Action plan in case of failure of in-process checks/challenge test for pharmacode reader for cartons and leaflets:
5.4.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.4.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.4.3 Ensure that no carton should be on packing line.
5.4.4 Check the Item code of carton/leaflet and check for correct pharmacode which were packed in shipper.
5.4.5 Good cartons/mono cartons should be packed in shippers. Defective packs shall be transferred to respective primary area.
5.4.6 Destroy the defective packs and its packing material.
5.4.7 Reset the pharmacode reader of cartons/leaflets.
5.4.8 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.4.9 After compliance of in-process checks/challenge test start the packing activity.
5.4.10 Destroy the all rejects and same should be recorded in batch packing record.
5.5 Action plan in case of failure of in-process checks/challenge test for bottle unscrambler (container cleaning machine):
5.5.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.5.2 Remove the empty bottles which are in between container cleaning machine and counting machine.
5.5.3 Ensure that no filled bottle should be on packing line.
5.5.4 Unpack all filled bottles between the previous intervals in separate in-process container.
5.5.5 Reset the bottle cleaning machine for cleanliness of bottles.
5.5.6 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.5.7 After compliance of in-process checks/challenge test start the packing activity.
5.6 Action plan in case of failure of in-process checks/challenge test for tablet/Capsule counting machine:
5.6.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as QA-Head.
5.6.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.6.3 Ensure that no filled bottle should be on packing line. Remove all bottles form quarantine shipper and transferred in to respective primary area for rectification.
5.6.4 In primary area, defoil the bottles and check manually for correct count filled in a bottle in presence of IPQA officer.
5.6.5 Good bottles should be proceeded for capping activity. Defective bottles and its packing material shall be destroyed.
5.6.6 Set the tablet/capsule counting machine for correct count and perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.6.7 After compliance of in-process checks/challenge test start the packing activity.
5.7 Action plan in case of failure of leak test:
5.7.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.7.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.7.3 Remove the all blisters/Strips/Sachet/Bottle from packing line.
5.7.4 Collect the sample randomly from no. 1 shipper.
5.7.5 Perform the leak test on collected samples twice. After compliance of leak test in second time then release the quarantine shipper.
5.7.6 If leak test failure second time then defoil the quarantine shippers.
5.7.7 For Blister pack, set the blister pack machine parameters, machine speed, temperature of sealing station for proper sealing.
5.7.8 For Bottle pack, set the induction sealing machine parameters, conveyor speed, power percentage of induction sealer for proper sealing.
5.7.9 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.7.10 After compliance of in-process checks/challenge test start the packing activity.
5.7.11 Destroy the all rejects and same should be recorded in batch packing record.
5.8 Action plan in case of failure of in-process checks/challenge test for vision system for bottle line:
5.8.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.8.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.8.3 Ensure that all overprinting bottles are removed from packing line.
5.8.4 Check the each bottle visually for overprinting details and check the label for legibility. Bottles should be packed if no defect is observed.
5.8.5 The defective bottles should be transferred in to respective primary area for destruction.
5.8.6 Defective bottles and its packing material shall be destroyed.
5.8.7 Set the vision system for labeling machine, and perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.8.8 After compliance of in-process checks/challenge test start the packing activity.
5.8.9 Destroy the all rejects and same should be recorded in batch packing record.
5.9 Action plan in case of failure of in-process checks/challenge test for vision system for vial labeling machine:
5.9.1 During batch packing operation failure of In-process checks/challenge test, immediately stopped packing activity and informs to production Head as well as Q.A. Head.
5.9.2 Quarantine the shipper packed between the previous in-process check/challenge test passed.
5.9.3 Remove all overprinting vials from line.
5.9.4 Quarantine the shipper packed between the previous intervals.
5.9.5 Check the each vial visually for overprinting details and check the item code of sticker label. The vials should be packed if no defect is observed.
5.9.6 The rejected vials should be, sorted, inspected and then loaded for further packing.
5.9.7 Problem should be rectified and line officer should ensure proper functioning of vision system before the starting the line.
5.9.8 Perform the In-process checks/challenge test by production officer verified by IPQA officer.
5.9.9 After compliance of in-process checks/challenge test start the packing activity.
5.9.10 Destroy the all rejects and same should be recorded in batch packing record.
6.0 ABBREVIATIONS:
OSD :Oral Solid Dosage
SOP :Standard Operating Procedure
IPQA :In process Quality Assurance
ALU :Aluminium