Direct Links to important GMP Biologic Guidelines

FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Inspection of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7341.002

Compliance Program CBER Biologics

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FDA Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A

Compliance Program CBER Biologics

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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

Compliance Program CBER Biologics

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FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002

Compliance Program CBER Biologics

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FDA COMPLIANCE PROGRAM GUIDANCE MANUAL Imported Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps) 7342.007 Addendum

Compliance Program CBER Biologics. General provisions pertaining to the scope and purpose of Part 1271, as well as definitions.

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Compliance Program Guidance Manual Chapter – 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices 7342.008

Compliance Program CBER Biologics

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FDA Compliance Program Guidance Manual Chapter – 45 Biological Drug Products Inspection of Biological Drug Products (CBER) 7345.848

Compliance Program CBER Biologics

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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

Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines

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FDA FEDERAL REGISTER Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review

categorizing of vaccines licensed before 1972

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FDA Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE

This guidance is intended to assist applicants and other responsible parties in fulfilling the FDA's existing postmarketing safety reporting requirements for human marketed drug and biological products at 21 CFR 310.305, 314.80, 314.98, 600.80, and 600.81 2.

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