| Handling of Returned Product |
1.0 OBJECTIVE To lay down the procedure for handling of returned drug product in quality assurance department. 2.0 SCOPE This procedure is applicable for involved in receipt, investigation, corrective and preventive actions (if any), reporting and documentation associated with returned products pertaining to drug products. 3.0 RESPONSIBILITY • Officer or above of Warehouse is responsible for retrieval of returned product. • Officer or above of Warehouse and Quality assurance is responsible for checking, receiving and holding the returned product. To read this SOP Click here SOP for Starting Material Non-Conformance/Discrepancy Intimation. 4.0 ACCOUNTABILITY Head Quality / QA 5.0 PROCEDURE 5.1 Returned Products – Any product, which is returned from the market, shall be considered as returned products. Drug product may be returned due to any one of the reasons mentioned below but not limited to: • Wrong supply of product to the customers • Market complaints. • Undistributed / unsold stock of products lying in company’s warehouses / depots or elsewhere other than manufacturing locations which may include expired products. • Damaged or broken primary containers mutilated or smudged labelling. • Returned products on advice of Drug Control Authorities, recalled products received as per SOP number XXX. 5.2 Head of Supply Chain department or his authorized nominee shall send Returned products to warehouse of manufacturing location by coordinating with carrying and forwarding (C&F) agents, marketing, sales department. 5.3 Upon receipt of returned product, Officer or above of Warehouse shall identify the returned product by name of the product, batch no. Expiry Date, Manufacturing Date against the received documents and record the relevant information in Returned Product Notification Form (RPNF) format no. QA01-008/F01and details of the same shall be entered in Returned product log format no. XXX. Warehouse personnel shall check the following: • The specified reasons for return of drug product. • Customer name and address that returned the product. • Physical condition of all the shippers/containers, and note the number of damaged containers/shippers (if any). • Quantity of shippers received and mentioned in returned documents. • Integrity of seal on each container/shipper. 5.4 After verification, the returned product shall be unloaded and quarantined in the Returned products area in a secured area under lock and key with label as “MARKET RETURNED PRODUCT UNDER HOLD” format No. XXX on each pallet on which the market returned product is kept. 5.5 Damaged shipper if received shall be segregated and shall be kept on separate pallet. 5.6 Officer or above of Warehouse shall check the excise invoice, damages and quantity. If any discrepancy observed, it shall be informed to Marketing, Customs and Excise. 5.7 Warehouse personnel shall prepare documents relevant to central excise wherever applicable and submit them for inspection. 5.8 After completion of excise inspection (If any), Warehouse personnel shall forward the “Returned product Notification Form” by recording the details to his/her Head of the department. 5.9 Head of Warehouse department shall mention his comments and forward the RPNF to Head of Quality Assurance. 5.10 Expired product, Product exposed to atmosphere and non-recoverable, regulatory directives and customer requirement. 5.11 Drug Product Salvaging: 5.11.1 The drug product shall be salvaged if: 5.11.2 There is evidence from laboratory tests and assay that the drug products meet all applicable standards of identity, strength, quality and purity. 5.11.3 There is evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage condition as a result of the disaster or accident (if applicable). 5.11.4 When determining whether drugs have been subjected to such improper conditions, following actions should include but not be limited to: 5.11.5 Obtaining supply chain information, including knowing the names and addresses of all suppliers and distributors of a drug (including components and packaging) to determine if there is a reasonable possibility that such materials were stored under improper conditions. 5.12 Repackaging of Returned Product: 5.12.1 If the returned product is advised for repackaging, then approval for the repackaging of returned product shall be taken from Head of QA department as mentioned format QA01-008/F04. 5.12.2 Production department shall prepare the action plan for repacking and forward the report to QA. 5.12.3 Repackaging activity shall be carried out as per procedure and shall be recorded in new Batch packaging record. 5.12.4 Quality Assurance Personnel shall monitor the repacking activity and record the relevant information in Batch packaging record. 5.12.5 The new Batch Packaging Record shall be kept with the original Batch Packaging Record for future reference. 5.12.6 After completion of the activity, Quality Assurance department shall review the report and authorize for the release. The repacked product shall be released as per the batch-releasing criteria. 5.13 Destruction of Returned Product: 5.13.1 Warehouse personnel shall initiate and record the relevant information for destruction of returned products format No. XXX.. 5.13.2 Quality Assurance personnel shall specify the reason for destruction based on Returned Product Assessment Report. 5.13.3 Approval for destruction of the returned products shall be obtained from Head QA. |
