Document Library

Document Library

Note regarding links on this page: These links lead to HTML versions of these documents for ease of navigation. Better formatted PDF versions are usually also available on the FDA site, if you would prefer this format.

FDA Documents online

	Part 210 - cGMPs in Manufacturing, Processing, Packing, or Holding of Drugs; General
	Part 211 - cGMPs for Finished Pharmaceuticals
	21 CFR Part 600, Subchapter F "Biologics"
	Guideline on Sterile Drug Products Produced by Aseptic Processing (1987)
	DRAFT Guideline Sterile Drug Products Produced by Aseptic Processing (2003)
	Guideline on General Principles of Process Validation (1987)
	Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (1998)
	21 CFR Part 11: Electronic Records; Electronic Signatures
	Proposed Revision to CGMPs 5/96
	The FDA's Development, Issuance, and Use of Guidance Documents (1997)

CBER Documents online

CBER Guidance Documents

Cooperative Manufacturing Arrangements for Licensed Biologics (1999)

Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)

Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997)

Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing (2001)

Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation (1999)

FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of Biological Products (1995)

Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy (1998)

CDER Documents online

CDER Regulatory Guidance Documents

Guideline on the Preparation of Investigational New Drug Products (Human and Animal) (1991)

FDA Compliance Program Guidance

Drug Manufacturing Inspections Program 7356.002 (2002)

Inspections of Licensed Biological Therapeutic Drug Products 7356.002M (2003)

Biotechnology Inspection Guide Reference Materials and Training Aids (1991)

Compliance Program Guidance Manual for Active Pharmaceutical Ingredients (APIs) 7356.002F

Guide to Inspections of Bulk Pharmaceutical Chemicals (1994)

Guide to Inspections of Validation of Cleaning Processes (7/93)

Guide to Inspections of Pharmaceutical Quality Control Laboratories (7/93)

Inspector's Technical Guide: Heat Exchangers to Avoid Contamination (7/79)

ICH TOPICS AND GUIDELINES

Q7A: Guide for Active Pharmaceutical Ingredients, GMP (2000)

Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin (1998)

Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (1996)

Validation of Analytical Procedures: Methodology (1996)

Quality of Biotechnological Products: Analysis of the Expression Construct in Cells used for Production of r-DNA Derived Protein Products (1996)

Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products (1998)

Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (1999)

Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (1999)

ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

European Union Documents

GMPs

Guidelines

Guidance on Minimizing Risk of Transmitting BSE

Other Documents

ISPE Baseline® Pharmaceutical Engineering Guides

ISPE GAMP4 (Good Automated Manufacturing Practice)

PDA Technical Reports

ISO 14644 series: Cleanrooms and associated controlled environments

Guidelines for Research Involving Recombinant DNA Molecules (NIH 1994)

What Is ICH?

Committed to reducing duplication during research and development of new drugs while safeguarding quality, safety and efficacy.

Developed over 40 guidance documents mostly addressing technical/regulatory requirements for registering new human drug products.

Edwin Rivera Martinez
CDER, FDA
Aug 2002

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