The contents of a final container of each filling of each lot shall be tested for identity after all labeling operations shall have been completed. The identity test shall be specific for each product in a manner that will adequately identify it as the product designated on final container and package labels and circulars, and distinguish it from any other product being processed in the same laboratory. Identity may be established either through the physical or chemical characteristics of the product, inspection by macroscopic or microscopic methods, specific cultural tests, or in vitro or in vivo immunological tests.
21 CFR Part 610 · General Biological Products Standards
§ 610.14 Identity
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FDA guidance that cites § 610.14
- Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers 9 Oct 2026
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products 31 Jan 2024
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry 28 Jan 2020
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
- Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry 1 Mar 1998
- Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies: Guidance for Industry 10 Apr 1997
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use 28 Feb 1997
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32056 20 Nov 1973