Course Reference List

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

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

Guidance for Industry documents represent the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Points to Consider (PTC) are not regulations nor are they guidelines, but represent the current thinking that the Center for Biologics Evaluation and Research (CBER) staff believe should be considered at this time.
Guide to Inspections are reference material for investigators and other FDA personnel. The documents do not bind FDA and do not confer any rights, privileges, benefits or immunities for or on any person(s). An alternative approach may be used if such an approach satisfies the applicable statutes, regulations or both.

	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/