Direct Links to important GMP Biologic Guidelines
Guidance for Industry: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
FDA Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals
FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002
FDA Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A
FDA Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002
FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum
Compliance Program Guidance Manual Chapter – 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices 7342.008
FDA Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848
FDA Guidance for Industry Characterization and Qualification of Cell Substrates and Other Guidance for Industry Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious D
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