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.”
Posted by Tim Sandle
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