PROFILE
QUALITY POLICY
CAREERS
DEBORAH CAMPBELL
GRAHAM MILLS
ASSOCIATES
LARGE PROJECT CONSULTING
AUDITS
QUALITY CONTROL OFFICER
EXPORTING
REGULATORY
VALIDATION
TECHNICAL WRITING
GMP TRAINING
LABORATORY
LARGE PROJECT CONSULTING
AUDITS
QUALITY CONTROL OFFICER
EXPORTING
REGULATORY
VALIDATION
TECHNICAL WRITING
GMP TRAINING
QUICKNOTES
THE GMP GAZETTE
INDUSTRY LINKS
cGMP/GMP BOOKLETS
Industry Links
Where do you find current regulations and guidances on the Web? Right here. Access FDA, Health Canada, ICH, and other industry websites. Bookmark this page to keep this information at your fingertips.
U.S. Food and Drug Administration (FDA)
U.S. FDA
CBER - Center for Biologics Evaluation and Research
CDER - Center for Drug Evaluation and Research
US FDA - Current Good Manufacturing Practices for human pharmaceutical products and veterinary products - CFR Title 21, Food and Drugs,
Part 210
- (To complete search, enter 21CFR210)
US FDA - Current Good Manufacturing Practices for human pharmaceutical products and veterinary products - CFR Title 21, Food and Drugs,
Part 211
- (To complete search, enter 21CFR211)
US FDA - Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach
US FDA - Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach: Second Progress Report and Implementation Plan
US FDA - Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach: Final Report - Fall 2004
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
US FDA - Orange Book
US FDA - Medical Devices - CFR Title 21, Food and Drugs, Part 820
US FDA - Biological Products - CFR Title 21, Food and Drugs, Part 600
National Nutritional Foods Association (NNFA)
Internet for Pharmaceutical and Biotech Communities
Health Canada
What's New (HPFBI)
TPD Index
What's New (TPD)
GMP Guidelines, 2009 Edition Version 2, GUI-0001 (Published 2011)
Biologics
Medical Devices (TPD)
Natural Health Products Directorate
Natural Health Products Compliance Guide (January 2007 - Version 2.1)
Veterinary Drugs Directorate
Food and Drugs Act
Food and Drug Regulations
Canada Competition Bureau - Guide to the Consumer Packaging and Labelling Act and Regulations
Guidance document "How to submit a Consumer Complaint - Guide 0044"
Guidance document "How to submit a Trade Complaint - Guide 0038"
International Conference on Harmonisation (ICH)
www.ich.org
European Union (EU)
European Medicines Agency: European regulatory and administrative requirements, especially for biotech products
European Directorate for the Quality of Medicines and Healthcare: information about Ph.Eur., Certificates of Suitability, EP Reference Standards
Medicines and Healthcare Products Regulatory Agency (MHRA)
www.mhra.gov.uk
Other Links
United States Pharmacopeial Convention Inc. (USP)
Pharmaceutical Inspection Convention (PIC/S)
International Organization for Standardization (ISO)
Pharmaceutical Sciences Group (PSG)
Internet for Pharmaceutical and Biotech Communities
Introduction to Current Good Manufacturing Practices
Quality & Compliance Services Inc. (This web site - Home page)
Quality & Compliance Services Inc. (Canadian web site)
NHP Compliance (The NHP and Dietary Supplements services division of Quality & Compliance Services Inc.)
ValidaPharm™ (The validation services division of Quality & Compliance Services Inc.)
Contact us at 1-877-877-5152 ext 210
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Canada:
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