Health Canada’s new NHP GMP Inspection Pilot Program is here and depending on the outcome, it could be here to stay. If made permanent, this program will mark the beginning […] Read More >>
In response to the COVID-19 pandemic, Health Canada implemented in March and April 2020 interim measures aimed to facilitate the importation of products that can help to limit the spread […] 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 >>
DR. MOHAMMAD KHALID, PH.D., B.SC.(HONS) Dr. Khalid is the leading GMP expert at dicentra. He helps dicentra’s clients reach compliance with the FDA GMP Rule for Dietary Supplements (21 CFR […] Read More >>
GMPs are a set of industry best practices to help ensure the safety, quality and efficacy of a natural health product. Natural health products (NHPs) are a valuable tool in […] Read More >>
March 26, 2013: dicentra conducted its first webinar of 2013. Critical American and Canadian updates including FDA’s proposed rules to amend cGMPs for food facilities under FSMA, the FDA’s Draft […] Read More >>
By: William Morkel, BSc Director of Quality & Compliance Recent closure of a testing laboratory in Mississauga, Ontario by Health Canada illustrates the need for companies to audit third party/contract […] 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 >>
August 28, 2012 A Quick Note…. There have been a number of significant developments on the regulatory front for dietary supplements in the United States lately. For example, dietary supplement […] 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 & Senior Regulatory Specialist for Dietary Supplements On July 16, 2012, the U.S. Food & Drug Administration (FDA) filed an injunction against a New York […] Read More >>
By Manushvi Chadha, BPharm, RA Cert NHP, Cosmetic and Drug Regulatory Affairs Associate As of June 2012 the Natural Health Product Directorate (NHPD) has released a document outlining their new […] 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 >>
By Ryan Ramdeo, International Regulatory Affairs Associate February 27, 2012 As of February 17, 2012 USDA has announced revisions to the requirements for the export of meat products to the […] Read More >>
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