Downloadable Documents

The document files below are in Adobe Portable Document Format (.pdf).

Selected Regulations

21 CFR Part 11—Electronic Records, Electronic Signatures

21 CFR Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies (GLPs)

21 CFR Part 210—Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, General GMPs)

21 CFR Part 211—Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMPs)

21 CFR Part 310—New Drugs

21 CFR Part 312—Investigational New Drug Application (IND)

21 CFR Part 314—Applications for FDA Approval to Market a New Drug (NDA)

21 CFR Part 600—Biological Products, General

21 CFR Part 610—General Biological Products Standards

21 CFR Part 803—Medical Device Reporting

21 CFR Part 809—In Vitro Diagnostic Products for Human Use

21 CFR Part 812—Investigational Device Exemptions (IDE)

21 CFR Part 814—Premarket Approval of Medical Devices (PMA)

21 CFR Part 820—Quality System Regulation (QSR)

21 CFR Part 860—Medical Device Classification Procedures

21 CFR Part 1271—Human Cells, Tissues, and Cellular and Tissue-Based Products

42 CFR Part 493—Laboratory Requirements(Clinical Laboratory Improvement Amendments of 1988 - CLIA)

California Sherman Food, Drug and Cosmetic Laws

Selected Guidance Documents

CBER/CDER Guidance: INDs—Approaches to Complying with CGMP During Phase 1 (2006)

CDER Guidance: Exploratory IND Studies(2006)

CBER Guidance: Content and Review of Chemistry, Manufacturing, and Control(CMC) Information for Human Gene Therapy Investigational New Drug Applications(2004)

CBER/CDER Guidance: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (2006)

CBER/CDER Guidance: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (2004)

General Principles of Software Validation (2002)

ICH/FDA Guidance: Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (2001)

CBER Guidance: Cooperative Manufacturing Arrangements for Licensed Biologics (1999)

ORA/CDRH Guidance: Guide to Inspections of Quality Systems (1999)

ICH/FDA Guidance: E6 Good Clinical Practice:  Consolidated Guidance (1996)

CBER/CBER Guidance: Guidance on General Principles of Process Validation (1987)

Website Links

FDA Home Page

CBER Home Page

CDER Home Page

CDRH Home Page

FDA/ORA (Office of Regulatory Affairs - FDA Field Operations)

FDA Search Page

CLIA - Clinical Laboratory Improvement Amendments

CDC Home Page

NIH - rDNA and Gene Transfer

NIST-National Institute of Standards and Technology

The Code of Federal Regulations

Federal Register

FDB (California Food and Drug Branch)

Foreign Regulatory Agencies and other Regulatory Websites

Health Canada-Health Products and Food Branch

EMEA (EU Regulatory Body)

EU cGMPs

Japan Ministry of Health, Labor and Welfare

ICH Home Page

WHO/OMS: World Health Organization

Commercial/Professional Websites

21 CFR Part 11 Compliance Website

AABB - American Association of Blood Banks

ATCC (American Type Culture Collection)

BioPharm International

FACT (The Foundation for the Accreditation of Cell Therapy)

FOI Services (Source for FDA Inspection Results)

IBC USA Conferences Inc.

IEST (Institute of Environmental Sciences and Technology)

ISCT (International Society for Cellular Therapy)

ISO (International Organization for Standardization)

ISPE (International Society for Pharmaceutical Engineering)

Netcord-FACT

PDA (Parenteral Drug Association)

U.S. Pharmacopeia