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3 Apr 2017 After years of working in and consulting for pharmaceutical and medical device companies on quality and regulatory matters, I am still somewhat surprised by the difficulty both industries have in understanding the other's Current Good Manufacturing Practices (CGMP) requirements. In some cases, the
13 Apr 2012
GMPs: Medical Device. Profitability rests on product quality, operational efficiency and regulatory compliance. The common denominator of those objectives is the ability of employees – regardless of business function or physical location – to apply the right knowledge needed at the right time to fulfill their job responsibilities.
This regulation became effective on December 18, 1978, and was codified under part 820. In 1990, FDA undertook the start of the revision of the CGMP regulation to add the design controls authorized by the Safe Medical Devices Act.
1 May 2015 SUMMARY: The Food and Drug Administration (FDA) is revising the current good manufacturing practice (CGMP) requirements for medical devices and incorporating them into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities
Everything your business needs to know about GMP compliance: 21 CFR Food, Pharma, Medical Device, Blood GMPs.
Since 1996, the requirements for the development, the manufacture and the distribution of medical devices in the USA have been laid down in the revised cGMP regu- lations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA's Center for Devices and Radiological Health (CDRH).
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
FDA has kept its guidelines on medical devices GMP regulations broad and flexible.The QS regulation for FDA Medical Device GMP Guidelines has what it calls an umbrella approach to the cGMP regulation.
Information Guide to GMP Compliance: FDA, Pharma, Manufacturing, Auditing.

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March 2018