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API Small Molecule Plant of the Future in PE Magazine
Read A Pharmaceutical Engineering Jan/Feb 2012 Online Exclusive article discussing the next generation of facilities, equipment, and processes as part of the “API Small Molecule Plant of the Future.”

Make an Impact and Volunteer with the Active Pharmaceutical Ingredients (API) COP
To view Volunteer Openings Click here

 

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.

 

COP Mission

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.

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Community Discussions

  • Validation of API Blending
    Active Pharmaceutical Ingredients, 11 June, (1 comment)
    How should I ideally validate the blending process of an API (only API- no excipients included)? I ... Continue reading
  • Desalting by Nano membrane filtration
    Active Pharmaceutical Ingredients, 7 June, (1 comment)
    We have a reaction mixture which has a product having 1500 Molecular weight.This is highly soluble i ... Continue reading
  • 2013 API COP GOALS
    Active Pharmaceutical Ingredients, 6 June, (1 comment)
    Please check out our 2013 API COP Goals under the "Resources" tab. If anyone is interested in contr ... Continue reading
  • Continuous O2 and Hydrogen monitors
    Active Pharmaceutical Ingredients, 4 January, (4 comments)
    I'm looking to replace our existing continuous O2 and hydrogen monitors in the processing areas. Any ... Continue reading
  • 21 CFR Part 11
    Active Pharmaceutical Ingredients, 18 November, (8 comments)
    Hello. Are requirements of 21 CFR Part 11 mandatory for production of APIs. How do you approach to e ... Continue reading