About the API COP
The Active Pharmaceutical Ingredients Community of Practice (API COP) has about 1,400 members representing
the various disciplines associated with active pharmaceutical ingredients such as Manufacturing, Process
R&D, Quality Control/Quality Assurance, and Regulatory Affairs.
The API COP's mission is to be a global leader and educational resource for all technical aspects of the
regulatory compliant development and manufacture of small molecule active pharmaceutical ingredients
throughout the entire lifecycle.
How to Get Involved
As an API COP member you can access technical
discussions or download presentations or files. You can
complete a volunteer profile and share your expertise with the
community. Note that only ISPE Members can engage in these activities.
Flexible API Manufacturing Session at the Annual Meeting
Active Pharmaceutical Ingredients, 2 October,
The API COP is leading a Flexible API Manufacturing session at the upcoming annual meeting in Novemb ...
Distribution loop for water for API.s
Active Pharmaceutical Ingredients, 27 September,
We have a small scale unit manufacturing two API's.Since requirement of water for manufacture and c ...
What parametrs do you need to check for cleaning verification by UV methods
Active Pharmaceutical Ingredients, 29 August,
Data reviewing and approving
Active Pharmaceutical Ingredients, 5 July,
Can someone tell me what is the usual industry practice for in-process data checking that is generat ...
Validation of API Blending
Active Pharmaceutical Ingredients, 11 June,
How should I ideally validate the blending process of an API (only API- no excipients included)?