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



CBER Guidances / Guidelines / Points to Consider


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


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


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


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


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


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


Guideline on General Principles of Process Validation, May 1987


FDA Guide to Inspections

Web Address


Biotechnology Inspection Guide Reference Materials And Training Aids


Guide To Inspections Of High Purity Water Systems


Guide To Inspections Of Sterile Drug Substance Manufacturers


Guide To Inspections Validation Of Cleaning Processes




FDA Points To Consider

Web Address


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


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




European Union

Web Address


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


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

  Concerning Chemical, Pharmaceutical And Biological Documentation For Biological Medicinal Products

  The European Agency for the Evaluation of Medicinal Products

Other Resources

Web Address


ISPE Turn Over Package Guide


Health Canada - Good Manufacturing Practices Guidelines - 2002 edition


Health Canada - Process Validation: Aseptic Processes for Pharmaceuticals
  Health Canada - Cleaning Validation Guidelines

Health Canada - Validation Guidelines for Pharmaceutical Dosage Forms

Health Canada - Process Validation: Moist Heat Sterilization for Pharmaceuticals

European Hygienic Equipment Design Group (EHEDG)