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

Sep 2006
PDA Item Number

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

PDF Single user
Member Price
Nonmember Price
Government Price

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.

Available to download immediate

Format: PDF (1 file – 294 KB)

Click here for the digital downloading instruction and Terms of Usage.

Please click here to order the paper ship version.

2006. Supplement Volume 60, No. S-2.

*To purchase licensing, please contact PDA at [email protected].

Table of Contents

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