Direkt Links to important GMP Biologic Guidelines

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FDA Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE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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FDA Guidance for Industry Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications

This guidance document provides recommendations for the submission of a biologics license application (BLA) (21 CFR Part 601) for placental/umbilical cord blood products that are: manipulated minimally; and intended for hematopoietic reconstitution in patients with hematological malignancies; and intended to be used in recipients unrelated to the donor.

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FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs

This guidance is intended to assist in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.2 These drugs, which include biological drugs, are exempt from complying with 21 CFR part 211 under 21 CFR 210.2(c) (referred to as phase 1 investigational drugs).

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FDA Guidance for Industry Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments

Developing Medical Imaging Drug and Biological Products

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GMP Conferences by Topics

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