Key FDA Compliance Guidelines

Comprehensive List of FDA Guidance Documents

Blood/Biotechnology
Cosmetics
Drugs
Food
Medical Devices
Positron Emission Tomography

Blood/Biotechnology

Biotechnology Inspection Guide (November 1991)

Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (May 2002)

Draft Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components - [PDF], [HTML] (October 2002)

Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information [Word]  [PDF]  (September 2003)

Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of donor Test Results for Antibody to HCV (Anti-HCV) (June 1999)

Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices (November 2000)

Guideline for Quality Assurance in Blood Establishments (July 1995)

Guide to Inspections of Infectious Disease Marker Testing Facilities (October 1996)

Review Checklist (Blood) (September 2006)

Cosmetics

Cosmetic Good Manufacturing Practice Guidelines

FDA's Cosmetic Labeling Manual (October 1991)

Guidance for Industry - Cosmetics Processors and Transporters Cosmetics Security Preventive Measures Guidance (19 March 2003) 

Guide to Inspections of Cosmetic Product Manufacturers

Inspections of Cosmetics (February 2003)

Drugs

Comprehensive List of CDER Guidance Documents

Active Pharmaceutical Ingredient (API) Process Inspection; Compliance Program Guidance Manual

Compliance Program Guidance Manual For FDA Staff:  Drug Manufacturing Inspections (February 2002)

Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers (May 2002)

Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information [Word]  [PDF]  (September 2003)

Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [HTML] - [PDF] - [Word] (September 2004) 

Draft Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice [DOC]  [PDF] (January 2006) Updated!!

Draft Guidance for Industry on Sterile Drug Products Produced by Aseptic Processing [PDF] (September 2003)

Draft Guidance for Industry: Process Analytical Technology--A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance  [PDF]  (September 2004) 

General Principles of Process Validation (May 1987)

Glossary of Computerized Systems and Software Development Terminology (August 1995)

Guidance for Industry and FDA — Current Good Manufacturing Practice for Combination Products [HTML] - [PDF] - [Word] (September 2004) 

Guidance for Industry: INDs--Approaches to Complying with CGMP's for Phase 1 Drugs [HTML] or [PDF] or [Word] (January 2006) New!!!!

Guidance for Industry: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [HTML] - [PDF] - [Word] (September 2004) 

Guide to Inspections of Dosage Form Drug Manufacturers - CGMP’s (October 1993)

Guide to Inspections of Foreign Pharmaceutical Manufacturers (May 1996)

Guide to Inspections of High Purity Water Systems (July 1993)

Guide to Inspections of Lyophilization of Parenterals (July 1993)

Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories (July 1993)

Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development & Validation (January 1994)

Guide to Inspections of Oral Solutions and Suspensions (August 1994)

Guide to Inspections of Pharmaceutical Quality Control Laboratories (July 1993)

Guide to Inspections of Sterile Drug Substance Manufacturers (July 1994)

Guide to Inspections of Topical Drug Products (July 1994)

Guide to Inspections of Validation of Cleaning Processes (July 1993)

Human Drug CGMP Notes

ICH Q7A - Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Final Guidance  (August 2001)

Presentation on ICH Q7A Good Manufacturing Practice Guidance for APIs and Its Use During Inspections (August 2002)

Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs

A Review of Procedures for the Detection of Residual Penicillins in Drugs  [PDF] (November 1977)

SUPAC 

Immediate Release Solid Oral Dosage Forms - Scaleup and Post Approval Changes:  Chemistry, Manufacturing, and Controls, In Vitro Dissoultion Testing, and  In Vivo Bioequivalence Documentation (November 1995) 

Modified Release Scaleup and Post Approval Changes:  Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and  In Vivo Bioequivalence Documentation (September 1997)

Non-Sterile Semisolid Dosage Forms Scaleup and Postapproval Changes:  Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (May 1997)

Food

Defect Action Levels (DALS) (1995; Revised March 1997, Revised May 1998)

Foods -- Adulteration Involving Hard or Sharp Foreign Objects (February 1999) Compliance Policy Guide Chapter 5 Subchapter 555 Section 555.425

Guidance for Industry:  Food Producers, Processors, Transporters, and Retailers:  Food Security Preventive Measures Guidance (19 March 2003)

Guidance for Industry - Importers and Filers:  Food Security Preventive Measures Guidance (19 March 2003)

Guidance for Industry: Juice Hazards and Control Guidance: First Edition (Final Guidance) (3 March 2004) 

Guidance For Industry: The Juice HACCP Regulation Questions and Answers (September 2003)

Guidance for  inspecting food establishments for allergenic substance contamination (August 2001)

Guide to Inspection of Aseptic Processing and Packaging for the Food Industry (February 2001)

Guide to Inspections of Interstate Carriers and Support Facilities (April 1995)

Guide to Inspections of Miscellaneous Food Products - Volume 1 (May 1995)

Guide to Inspections of Miscellaneous Food Products - Volume 2 (September 1996)

Importers and Filers: Food Security Preventive Measures Guidance (March 2003)

Risk Assessment For Food Terrorism and Other Food Safety Concerns (October 2003) 

Medical Device

Design Control Guidance For Medical Device Manufacturers (March 1997)

Do It By Design: An Introduction To Human Factors in Medical Devices (December 1996)

Draft GMP Compliance Program (May 1998)

General Principles of Software Validation (January 2002)

Guide to Inspections of Foreign Medical Device Manufacturers 

Guide to Inspections of Medical Device Manufacturers (December 1997)

Human Factors Implications of the New GMP Rule (April 1998)

Inspection of Medical Device Manufacturers [HTML] [PDF] (June 2006)

Positron Emission Tomography

FDA Approach to PET CGMP (May 2002)

PET Drug Products - Current Good Manufacturing Practice (CGMP)  [PDF] [DOC] (September 2005) NEW!!!

Comprehensive List of  FDA Guidance Documents

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