Category: USFDA CFR

Drug product salvaging as per USFDA CFR 211.208 Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Whenever there is a question about whether drug…

Expiration dating as per USFDA CFR 211.137 (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166. (b) Expiration dates shall be related to any storage conditions stated on…

Stability testing as per USFDA CFR 211.166 (a) There shall be a written testing program designed to assess the stability characteristics of drug products. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include: (1) Sample size and test…

General requirements For Laboratory Controls as per USFDA CFR 211.160 (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or,…

Laboratory records as per USFDA CFR 211.194 (a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows: (1) A description of the sample received for testing with identification of source (that is, location from where sample was obtained), quantity,…

Complaint files as per USFDA CFR 211.198 (a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of…

Distribution records as per USFDA CFR 211.196 Distribution records shall contain –   The name and strength of the product Description of the dosage form Name and address of the consignee Date and quantity shipped Lot or control the number of the drug product. For compressed medical gas products, distribution records are not required to contain…

Production record review (USFDA CFR 211.192) All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding…

Returned drug products (USFDA CFR 211.204 ) Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored or shipped before or during their return, or If the condition of the drug product, its container, carton, or labeling, as a result of storage or…