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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

  • Equipment Wear and Tear
    Active Pharmaceutical Ingredients, 15 May, (1 comment)
    Does anyone have a good reference for defining equipment wear and tear? Especially for agitator sea ... 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
  • Clobutinol
    Active Pharmaceutical Ingredients, 31 October, (1 comment)
    I need contact a provider of Clobutinol. Many Thanks ... Continue reading
  • MACO Limits Cleaning Validation, daily dose or therapeutic dose
    Active Pharmaceutical Ingredients, 27 October, (5 comments)
    Though the topic is old, calculation of maximum allowable carryover still seems to be not finally de ... Continue reading