In-PharmaTecnologist.com’s Zach Brennan wrote a recent article about Canada’s agreement to strengthen the GMP requirements on active pharmaceutical ingredients (API). Canada is one of the last industrialized countries to extend GMP requirements on APIs but in doing so it will enhance the traceability of APIs throughout the supply chain process, decrease the amount of product recalls, and provide more serviceable products to Canadians. The new regulations will take effect in November of 2013 and the country’s drug establishment license requirements will then apply to API manufacturers, packagers/labelers, testers, and importers. Also, extending the GMP requirements on APIs will act as protection from poor quality drug products for Canadians. The transition process will be tough for some manufacturers but the government will let them do business without an establishment license as long as they have applied for one by February of 2014. For more details and the full article click here.
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