No lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product. Each applicable test shall be made on each lot after completion of all processes of manufacture which may affect compliance with the standard to which the test applies. The results of all tests performed shall be considered in determining whether or not the test results meet the test objective, except that a test result may be disregarded when it is established that the test is invalid due to causes unrelated to the product.
21 CFR Part 610 · General Biological Products Standards
§ 610.1 Tests prior to release required for each lot
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What FDA inspectors cite under § 610.1
Form FDA 483 observations citing this section, fiscal years 2015–2023 (Biologics).
- Tests prior to release 2
- Consideration of all results 1
FDA guidance that cites § 610.1
- Potency Assessment of Active Immunotherapy Products draft 19 Aug 2026
- Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products draft 29 Apr 2024
- Potency Assurance for Cellular and Gene Therapy Products draft 27 Dec 2023
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: 1 Jan 2011
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry 10 Apr 1997
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32056 20 Nov 1973