Bulletin Board

Can you effectively conduct internal audits?
Attend the GMP Auditing Training Course offered in May in Indianapolis.

 

About the Process/Product Development COP

The PPD COP has more than 1,200 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.

 

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

  • Cycle Development for Moist-heat Sterilization
    Process/Product Development, 29 April, (1 comment)
    A basic question: It is acceptable practice for solutions (up to 15 L) going into an aseptic proce ... Continue reading
  • New FDA Guidance SUPAC Mfg equipment addendum
    Process/Product Development, 12 April, (2 comments)
    The previous SUPAC equipment addendum indicated: Quote "Equipment within the same class and subc ... Continue reading
  • Quality by Design
    Process/Product Development, 10 April, (2 comments)
    I would like to know what is the preferred alternative regarding the way to determine the number of ... Continue reading
  • Process Validation Requirements
    Process/Product Development, 12 March, (4 comments)
    If a number of batches of parenteral drug are manufactured (phase 3), and the last 3 consecutive lot ... Continue reading
  • Deyprogenation
    Process/Product Development, 6 March, (1 comment)
    The facility I work at has traditionally used depyrogenation (oven) of glassware, stainless vessels, ... Continue reading