Good Manufacturing Practices: The FDA’s Year in Review
In December of 2018, the FDA released a report: Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This communication replaced the 2014 guidelines, and included several updates to protocol. Among these were testing for shelf-life and stability of medications, storage of reserve samples in the lab, and crucially, differentiating between sterile and non-sterile drug compounds in storage and other considerations.
These changes come shortly in advance of the 2020 start date of the new Medical Device Regulations issued by the European Union, and on the heels of the late 2017 agreement between the EU and our country to share Good Manufacturing Practice inspection results for all pharmaceutical facilities that manufacture medications distributed across our combined markets.
With so many changes to the good manufacturing practices policies in place in the domestic and international market, and more to come each year, it is essential that pharmaceutical companies have GMP professionals who have up-to-date training, and the ability to anticipate the future of the FDA’s regulation in this area, and plan for R&D changes appropriately.
Our Current Good Manufacturing Practices (cGMP) Certified Professional™ program ensures both of these crucial points are addressed, plus allows you to tailor your learning specifically to your company’s pain points, with 20 courses to choose from to make up the four-course requirement.
Best of all, our knowledgeable instructors have 20+ years of cGMP experience, as well as a deep understanding of the pivotal role good manufacturing practices play in drug development for pharmaceuticals and biologics.
If you’d like to learn more about preparing your company for the future of cGMP, visit the program page or explore our full list of training in pharmaceuticals and biotech.
Source:
https://www.natlawreview.com/article/fda-2018-year-review-good-manufacturing-practice
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