According to the Code of Federal Regulations (21 CFR 211.150 Distribution procedures), each manufacturer must develop, maintain, and implement a written distribution procedure.
(a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate.
(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.
A company recently received the following 483 observation:
…. Written distribution procedures are not established.
Specifically, shipment of finished drug products using your firm’s components and containers have not been validated to ensure that temperature sensitive pharmaceuticals are consistently maintained within the designated temperature range during transit from your firm to the point of use, and that their identity, strength, quality, and purity are not affected.
For example, the firm repackaged and/or relabeled drug products that have refrigerated storage conditions, but you stated that you have not validated controlled-temperature shipping which include APIs and/or raw materials.
For more information on conducting stability studies, refer to FDA guidance document, Q1A(R2) Stability Testing of New Drug Substances and Products.
For more information on storage and transportation strategies, refer to USP General Chapter <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.
To view more observations pertaining to storage distribution and stability, refer to the following GMP Trends® Issues: 1075, 1072, 1070, 1065, 1045 and 1042.
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