PROFILE
QUALITY POLICY
CAREERS
DEBORAH CAMPBELL
GRAHAM MILLS
ASSOCIATES
LARGE PROJECT CONSULTING
AUDITS
QUALITY CONTROL OFFICER
IMPORTING
REGULATORY
VALIDATION
TECHNICAL WRITING
GMP TRAINING
LABORATORY
LARGE PROJECT CONSULTING
AUDITS
QUALITY CONTROL OFFICER
IMPORTING
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 Health Canada, FDA, ICH, and other industry websites. Bookmark this page to keep this information at your fingertips.
Health Canada
What's New (HPFBI)
TPD Index
What's New (TPD)
GMP Guidelines, 2009 Edition, GUI-0001
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"
U.S. Food and Drug Administration (FDA)
U.S. FDA
Electronic Code of Federal Regulations
U.S. cGMP 21 Part 111
CBER - Center for Biologics Evaluation and Research
CDER - Center for Drug Evaluation and Research
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. (U.S.)
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
Canada:
9-6975 Meadowvale Town
Centre Circle, Suite 410
Mississauga, ON L5N 2V7
USA:
66 Witherspoon Street, Suite 1400
Princeton, NJ 08542
info@qualityandcompliance.com