Be aware that Health Canada is actively testing “Performance Supplements” on the market. Implementation of a quality program in accordance with GMP is the only way to ensure product integrity and avoid enforcement actions. Read More >>
The North American Compendium (NAC) has upgraded the software running the Interim Notification Pilot (INP) Program for Low Risk Veterinary Health Products (LRVHP), affecting certain aspects of the notification process. […] Read More >>
As of September 2, 2013, Health Canada is transferring the responsibility of International Trade Certificates issuance to independent 3rd parties. Any request received prior to September 2, 2013 will still […] Read More >>
The NHPD has recently released the finalized version of the “Quality of Natural Health Products Guide”, superceding the “Evidence for Quality of Finished Natural Health Products” after a 3 month […] Read More >>
Since the final good manufacturing practices (GMP) rule for dietary supplements was implemented in 2007, the Food and Drug Administration (FDA) has made it very clear that GMP inspections […] Read More >>
On July 24, 2012 the FDA issued a Warning letter to United Nutrition Labs for continually failing to comply with current Good Manufacturing Practices (cGMPs) after a thorough on-site […] Read More >>
By Heather VanBlarcom General Counsel and Senior Regulatory Specialist for Dietary Supplements It’s been no secret that obesity in the United States has been on the rise, largely due, in […] Read More >>
What is FDA Form 483? The FDA has started conducting inspections of establishments that manufacture, process, pack, or hold dietary supplements without prior notice to determine the establishment’s compliance with […] Read More >>
By Heather VanBlarcom General Counsel & Senior Regulatory Specialist for Dietary Supplements Over the weekend, the Chicago Tribune quoted Dr. Daniel Fabricant, head of the FDA’s Division of Dietary Supplement […] Read More >>
Current Good Manufacturing Practices (cGMPs) for Dietary Supplements have been in effect since June 2010 and the FDA has been increasing inspections each year since. In 2011, 145 FDA inspections […] Read More >>
By Heather Van Blarcom General Counsel & Senior Regulatory Specialist – USA If your name is on the label of a dietary supplement product that you market and distribute, you […] Read More >>
William Morkel, BSc Director of Quality and Compliance, dicentra If, based on my years of experience, I had to list the primary root causes for non-conformances in GMP regulated facilities, […] Read More >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, dicentra Inc. Under the current guidelines for Good Manufacturing Practices (GMPs) for Natural Health Products (NHPs), manufacturers and importers of […] Read More >>
William Morkel, BSc Senior Quality Assurance and Regulatory Affairs Specialist, Dicentra From late September to mid October the NHPD will be holding information sessions in Montreal, Toronto, Vancouver, and Halifax […] Read More >>
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