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EMA Guidance on Process Validation Available for Comments
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About the Process/Product Development COP

The PPD COP has more than 2,100 members representing the various stages associated with PPD such as discovery, development, commercialization, and manufacturing support. PPD activities also include companies working with API and Biotechnology, such as hospitals, doctors, and companies that provide clinical support to volunteers and patients.

Download PPD COP Brochure ( 407 KB)
 

COP Mission

ISPE’s PPD COP aims to bridge the gap between R&D and Manufacturing and to create guidance documents that will be beneficial to the members of the PPD COP and the Society. The primary objectives of the PPD COP are:

  • Promote the integration of professionals focused on process/product development and technology transfer
  • Champion innovative concepts in the industry
  • Provide a platform for advanced level content and the delivery of a body of knowledge in ISPE continuing education
  • Produce technical documents, articles, and papers
  • Collaborate with the regulatory community on behalf of the industry

How to Get Involved

As a PPD 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.

Community Discussions

  • Continuous Processing - What is the impact to Development?!
    Process/Product Development, 8 May, (1 comment)
    On the Biotech COP discussion board there is a request for information related to continuous or semi ... Continue reading
  • APS Amorphous IV: Hot Melt Extrusion, Greenwhich UK
    Process/Product Development, 3 May, (1 comment)
    APS Amorphous IV: Hot Melt Extrusion: 12th - 13th June 2012, The School of Science in the University ... Continue reading
  • ICH, FDA, EMA and Process validation
    Process/Product Development, 30 April, (1 comment)
    Why is it possible that EMA and FDA have two guidance documents related to Process Validation (final ... Continue reading
  • Product & Process LC Mgmt.
    Process/Product Development, 25 April, (1 comment)
    Dear Colleagues I am wondering if you are interesting (presentation available) in a novel approa ... Continue reading
  • SCORED TABLETS NEW FDA DRAFT GUIDELINE
    Process/Product Development, 13 February, (1 comment)
    The new FDA draft for Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation suggest the fo ... Continue reading