This Technical Report was prepared by the Joint PDA/PhRMA
Sterile Bulk Pharmaceutical Chemicals Task Force.
This document provides guidance relative to the validation of aseptic processing
activities utilized for the production of sterile bulk pharmaceutical chemicals.
It draws upon the concepts and principles developed in PDA`s and PhRMA`s prior
publications on aseptic processing technology. This second edition (2006) updates
the first edition, which was originally published in 1998, to reflect six years
of industry experience, as well as an acknowledgement of acceptance criteria
limitations that were present in the first edition. It has also endeavored to
address some of the issues raised by FDA in their review of the earlier edition.
2006. Supplement Volume 60, No. S-2.
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Table of Contents:
2. Process Simulation Concepts and Principles
Simulation Test Methods
4. Test Materials Used in Process Simulation
Evaluation of Simulation Test Materials
8. Elements of Process Simulation Tests
9. Interpretation of
Results and Acceptance Criteria
10. Failure Investigation and Corrective
11. Periodic Reassessment
Appendix 1: Selection and
Sterilization of Test Materials
Appendix 2: Definitions