5.1 On authorization from Director-Operations regarding product return, Head-Marketing/Distribution shall organize to transfer the goods to manufacturing location along with a copy of product return authorization.
5.2 Head-Warehouse shall receive the goods and check the delivery Challan and excise invoice details.
5.3 The returned goods shall be stored in specified area de-marked separately with status boards indicating ‘returned goods’.
5.4 Record of returned drug product shall be filled as per Annexure-I with the following details:
i. Date of receipt at Warehouse.
ii. The name of the product
iii. Batch number.
iv. Mfg. date
v. Exp. Date
vi. Reason for return.
vii. Quantity returned.
5.5 Investigation report shall be prepared as per Annexure-II by warehouse with required product details. QA shall comment on decision of disposition (to be re-analyzed/repacked/destroyed) with the reason for return. Head-QC and Head-Production shall comments on decision of disposition if applicable.
5.6 Investigation report shall be finally approved by Head-QA.
5.7 Based on the report, disposition of the goods shall be decided whether to repack or salvage or destroy.
5.8 If the condition of drug product, its container, carton or labeling impact the safety, identity, strength, quality or purity of drug product, the returned product shall be destroyed.
5.9 The decision on salvaging or re-packing and return of repacked product into market shall be carried out only, if the drug product meets appropriate standards of safety, identity, strength, quality or purity upon investigation and testing.
5.10 In case of opening primary packaging material (risk of product exposure) testing shall be carried out before repacking or on repacked product as applicable. However release of repacked product into the market shall be approved by Head-QA after completion of complete analysis and compliance as per specification.
5.11 In case of secondary (Non product exposure) if the physical appearance of product/container/blister/vial is in good condition, then the product can be repacked without testing.
5.12 Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, and damage due to natural disastrous, fires, accidents or equipment failures shall not be salvaged and returned to market place.