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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.
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
- Promote the integration of professionals focused on process/product development and technology
- Champion innovative concepts in the industry
- Provide a platform for advanced level content and the delivery of a body of knowledge in ISPE continuing
- 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.
Cycle Development for Moist-heat Sterilization
Process/Product Development, 29 April,
A basic question:
It is acceptable practice for solutions (up to 15 L) going into an aseptic proce ...
New FDA Guidance SUPAC Mfg equipment addendum
Process/Product Development, 12 April,
The previous SUPAC equipment addendum indicated:
Quote "Equipment within the same class and subc ...
Quality by Design
Process/Product Development, 10 April,
I would like to know what is the preferred alternative regarding the way to determine the number of ...
Process Validation Requirements
Process/Product Development, 12 March,
If a number of batches of parenteral drug are manufactured (phase 3), and the last 3 consecutive lot ...
Process/Product Development, 6 March,
The facility I work at has traditionally used depyrogenation (oven) of glassware, stainless vessels, ...