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CGMP -Current Good Manufacturing Practice

What is CGMP?

CGMP standards for current good manufacturing practices. CGMP is the quality system required by the FDA for products within the food, drugs, biologics and devices industries. This regulation became effective originally as part of 820 21 CFR part 820 in 1978.

How are CGMP and ISO related?

Both CGMP and ISO are quality systems. Despite the fact that both serve the same purpose, there are differences between the two quality systems. The CGMP is a set of regulatory requirements that are mandated by law. Compared to ISO which is a voluntary certification obtained by a third party registrar. Both systems have similar requirements, but the failure to comply with ISO 13485:2016 would not result in an immediate regulatory action, compared to the failure of a CGMP inspection could result in an immediate regulatory action and/or prevention from distributing from entering, or distributed within the US.

The future of CGMP and ISO

In April of 2019, the FDA plans to make ISO 13485:2016 its required quality system replacing its existing Quality System Regulation (QSR 21 CFR 820). This transition is still in the making and is in the rule stage.

 

ISO 13485 All in One Package

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