USFDA CFR

Drug product salvaging as per USFDA CFR 211.208 Drug products that have been subjected to improper storage conditions including extremes

Expiration dating as per USFDA CFR 211.137 (a) To assure that a drug product meets applicable standards of identity, strength,

Stability testing as per USFDA CFR 211.166 (a) There shall be a written testing program designed to assess the stability

General requirements For Laboratory Controls as per USFDA CFR 211.160 (a) Any production, control, or distribution record that is required

Laboratory records as per USFDA CFR 211.194 (a) Laboratory records shall include complete data derived from all tests necessary to

Complaint files as per USFDA CFR 211.198 (a) Written procedures describing the handling of all written and oral complaints regarding

Distribution records as per USFDA CFR 211.196 Distribution records shall contain –   The name and strength of the product Description

Production record review (USFDA CFR 211.192) All drug product production and control records, including those for packaging and labeling, shall

Returned drug products (USFDA CFR 211.204 ) Returned drug products shall be identified as such and held. If the conditions