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PDA Technical Report No. 28 Revised, (TR 28) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals

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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:

1. Introduction
2. Process Simulation Concepts and Principles
3. Process Simulation Test Methods
4. Test Materials Used in Process Simulation
5. Evaluation of Simulation Test Materials
6. Documentation
7. Environmental Monitoring
8. Elements of Process Simulation Tests
9. Interpretation of Results and Acceptance Criteria
10. Failure Investigation and Corrective Action
11. Periodic Reassessment
Appendix 1: Selection and Sterilization of Test Materials
Appendix 2: Definitions
Appendix 3: References

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