Reference List - Guidelines, Points to Consider and Other and Regulatory Information

FDA - CBER and CDER Divisions defines their reference documents as follows:

 

FDA Guidelines

Web Address

 

Comprehensive List of Current Guidance Documents at the Food and Drug Administration

http://www.fda.gov/cder/guidance/index.htm

 

 

CBER Guidances / Guidelines / Points to Consider

http://www.fda.gov/cber/guidelines.htm

 

Guideline on Sterile Drug Products Produced by Aseptic Processing, June 1987

http://www.fda.gov/cder/guidance/old027fn.pdf

 

Guidance for Industry Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

http://www.fda.gov/cber/gdlns/ichactive.pdf

 

Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices

http://www.fda.gov/cber/gdlns/lal.pdf

 

Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products

http://www.fda.gov/cber/gdlns/pilot.txt

 

Guidance For Industry For The Submission Of Chemistry, Manufacturing, And Controls Information For A Therapeutic Recombinant DNA-Derived Product Or A Monoclonal Antibody Product For In Vivo Use

http://www.fda.gov/cber/gdlns/cmcdna.pdf

 

Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products

http://www.fda.gov/cber/gdlns/sterval.pdf

 

Guideline on General Principles of Process Validation, May 1987

http://www.fda.gov/cdrh/ode/425.pdf

 

FDA Guide to Inspections

Web Address

 

Biotechnology Inspection Guide Reference Materials And Training Aids

http://www.fda.gov/ora/inspect_ref/igs/biotech.html

 

Guide To Inspections Of High Purity Water Systems

http://www.fda.gov/ora/inspect_ref/igs/high.html

 

Guide To Inspections Of Sterile Drug Substance Manufacturers

http://www.fda.gov/ora/inspect_ref/igs/subst.html

 

Guide To Inspections Validation Of Cleaning Processes

http://www.fda.gov/ora/inspect_ref/igs/valid.html

 

 

 

FDA Points To Consider

Web Address

 

Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology

http://www.fda.gov/cber/gdlns/ptcdna.pdf

 

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

http://www.fda.gov/cber/gdlns/ptc_mab.txt

 

 

 

European Union

Web Address

 

Volume 3A - GuidelinesMedicinal Products For Human Use Quality And Biotechnology

http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/vol3aen.pdf

 

Volume 4 - Good Manufacturing Practices Medicinal Products For Human And Veterinary Use

http://pharmacos.eudra.org/F2/eudralex/vol-4/home.htm

  Concerning Chemical, Pharmaceutical And Biological Documentation For Biological Medicinal Products

http://pharmacos.eudra.org/F2/eudralex/vol-2/B/pdfs-en/Part2_3en.pdf

  The European Agency for the Evaluation of Medicinal Products

 

http://www.emea.eu.int/index/indexh1.htm
 

Other Resources

Web Address

 

ISPE Turn Over Package Guide

http://www.ispe-sf.org/turnover.htm

 

Health Canada - Good Manufacturing Practices Guidelines - 2002 edition

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/gmp_guidelines_2002_e.pdf

 

Health Canada - Process Validation: Aseptic Processes for Pharmaceuticals

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/asep_proc_pharm_entire_e.html
  Health Canada - Cleaning Validation Guidelines http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/clean_val_gui_entire_e.html
 

Health Canada - Validation Guidelines for Pharmaceutical Dosage Forms

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/pharm_dos_form_entire_e.html
 

Health Canada - Process Validation: Moist Heat Sterilization for Pharmaceuticals

http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/moist_heat_ster_pharm_entire_e.html
 

European Hygienic Equipment Design Group (EHEDG)

http://www.ehedg.org/