Sunday, 21 July 2013

Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products


The FDA have issued a new guidance document entitled ‘Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products’.

The brief for the document reads: “This document provides guidance to industry and FDA staff on the applicability of current good manufacturing practice provisions to combination products as defined under 21 CFR 3.2(e). Such provisions apply to the manufacture of combination products to ensure that the product is not adulterated; the product possesses adequate strength, quality, identity, and purity; and the product complies with performance standards as appropriate for the marketed combination product.”

For further details, see A3P

Posted by Tim Sandle

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