Do you do API’s?

Do you do API’s?  Have questions?  If yes, you should check out – FDA’s Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients – Question and Answers.

Per the intro section –

Since the ICH Q7 Guidance was finalized, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections. This question and answer (Q&A) document is intended to respond to those requests. The ICH Q7 document should be read in its entirety regardless of the nature of the manufacturing activities being conducted to fully understand the linkages between certain sections and successfully implement appropriate good manufacturing practices (GMPs) at all stages of the active pharmaceutical ingredients (API) supply chain, including distribution. A table is provided as an annex of this document showing the link between each Q&A and the relevant sections of ICH Q7 and other ICH Quality guidance.

The Q&A addresses each section of ICH Q7.  The Annex of the guidance contains a road map of how the Questions and Answers are linked to the specific sections or paragraphs of ICH Q7.  Have a question – check to see if it is covered in the guidance or if you have a question on the qualification or validation of API manufacturing – please us the Contact Us form.

Performance Validation has several project summaries addressing API Facilities, please see the following as two examples:

Facility Renovation for New API

API Verification Support