Brazil Issues GMPs for APIs

In December 2014, The Brazilian Health Surveillance Agency’s Collegiate Board issued provisions on GMPs for APIs.

This is an interesting set of requirements as it incorporates a lot of the current ICH Q7 guidelines, along with Part 11 (software and hardware controls), some great definitions for your lexicon, and detailed expectations on contract manufacturing.  It also addresses requirements for APIs of plant origination.

Download the report PDF here.