21 CFR 211.165 Testing and Release for Distribution
Overview:
21 CFR 211.165 is a regulation by the U.S. Food and Drug Administration (FDA) that outlines requirements for testing and releasing drug products for distribution.
It applies to pharmaceutical manufacturers and quality control units, which must ensure that drug products meet specified standards for identity, strength, and safety before being released to the market.
(a)
For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.
(b)
There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.
(c)
Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.
(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels.
(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
(f)
Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria.
