Google
WWW ComplianceNet, Inc.
 
 

Document Library

 
 
Home
Consulting Services
Training
About Us
Contact Us
Upcoming Events
FDA News
Warning Letter Hot Topics
Links:  Regulatory and Industry
Document Library
cGMP Defined

 

 

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.  
       

 

 

 

bullet

FDA Documents online

bullet

Part 210 - cGMPs in Manufacturing, Processing, Packing, or Holding of Drugs; General

bullet

Part 211 - cGMPs for Finished Pharmaceuticals

bullet

21 CFR Part 600, Subchapter F "Biologics"

bullet

Guideline on Sterile Drug Products Produced by Aseptic Processing (1987)

bullet

DRAFT Guideline Sterile Drug Products Produced by Aseptic Processing (2003)

bullet

Guideline on General Principles of Process Validation (1987)

bullet

Guidance for Industry: Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (1998)

bullet

21 CFR Part 11: Electronic Records; Electronic Signatures

bullet

Proposed Revision to CGMPs 5/96

bullet

The FDA's Development, Issuance, and Use of Guidance Documents (1997)

bullet

CBER Documents online
bullet

CBER Guidance Documents

bullet

Cooperative Manufacturing Arrangements for Licensed Biologics (1999)

bullet

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

bullet

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

bullet

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

bullet

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

bullet

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

bullet

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

bullet

CDER Documents online
bullet

CDER Regulatory Guidance Documents

bullet

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

bullet

FDA Compliance Program Guidance

bullet

Drug Manufacturing Inspections Program 7356.002 (2002)

bullet

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

bullet

Biotechnology Inspection Guide Reference Materials and Training Aids (1991)

bullet

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

bullet

Guide to Inspections of Bulk Pharmaceutical Chemicals (1994) 

bullet

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

bullet

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

bullet

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

bullet

ICH TOPICS AND GUIDELINES 
bullet

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

bullet

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

bullet

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

bullet

Validation of Analytical Procedures: Methodology (1996)

bullet

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

bullet

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

bullet

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

bullet

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

bullet

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

bullet

European Union Documents
bullet

GMPs

bullet

Guidelines

bullet

Guidance on Minimizing Risk of Transmitting BSE

bullet

Other Documents
bullet

ISPE Baseline® Pharmaceutical Engineering Guides

bullet

ISPE GAMP4 (Good Automated Manufacturing Practice)

bullet

PDA Technical Reports

bullet

ISO 14644 series: Cleanrooms and associated controlled environments

bullet

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


Copyright 2003 Compliance Net, Inc.

Home  |  Contact Us