PDA Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals (single user digital version)

Mar 2018
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PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter<1790>: Visible Particulates in Injection.

In 2015, the PDA Task Force on Particulate Matter Control in Difficult to Inspect Parenterals initiated an industry survey on DIP products. literature, pharmacopeial references, and the collective expertise of Task Force contributors form the basis for the information provided in this technical report.

This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary
  3. Overview
  4. Expectations for DIP Inspection
  5. Inspection Approaches for DIP Products/Containers/Devices
  6. Defect Prevention: A Lifecycle Approach
  7. Conclusion
  8. References
  9. Appendix 1: Enhanced Methods for Revealing Visible Particles

Figures and Tables Index