Table of Contents
1.0 OBJECTIVE:
1.1 To lay down the procedure for terminal inspection of the finished pack.
2.0 SCOPE:
2.1 This SOP is applicable for terminal inspection of finished packs that are ready to transfer in the finished goods store.
3.0 RESPONSIBILITY:
3.1 IPQA person
3.2 Officer-QA
4.0 ACCOUNTABILITY:
4.1 Head of Quality Assurance
5.0 PROCEDURE:
5.1 terminal inspection of Finished product finally packed and staged on pallets with proper labels.
5.2 Check for the product particulars to be inspected as per the details given by the packing supervisor.
5.3 Check the Batch Processing Record thoroughly for the complete required entries in the relevant columns, duly signed and dated by the designated person.
5.4 Randomly select at least 10 % of the total number of finished packs.
5.5 Open the above selected finished pack one by one and check the following parameters and record them:-
5.5.1 Integrity and physical appearance of the pack.
5.5.2 Product name, batch number, Mfg. date, Exp. date, batch size, MRP, and packing style.
5.5.3 Corrugated box label, legibility, and correctness of coding details on it and in subsequent packing materials wherever coding is there.
5.5.4 Correctness of quantity/number of units and subunits in the corrugated box (finished pack) and subsequent inner packing.
5.5.5 Correctness of labeling and packing style.
5.5.6 Leakage: any tear, breakage or damage of product or of any packing material which warrants and exhibits quality not conforming to the set standards, like sealing, Knurling, printing strip/blister, cut pocket, half tablets, broken tablets, empty strip/blister, double-stand tablets, number of unit in inner & outer carton etc.
5.5.7 Record the defects observed on the above parameters on the “Terminal Inspection Report of Finished Pack.”
5.5.8 If the defects warrant a threat to the visual and intrinsic quality of the product, then put the batch under hold and inform the packing supervisor and In-Charge Production for the corrective actions.
5.5.9 Verify the corrective action taken by checking 10 % of the reworked finished pack and prepare the report. Sign the transfer ticket if the batch is released on the basis of the above observation.
5.5.10 If a critical observation is found as per the list, then it will be decided for 100% pack checking.
5.5.11 If repeated non-compliance is found, then hold the batch for re-correction.