PDA Technical Report No. 66, (TR 66) Application of Single-Use Systems in Pharmaceutical Manufacturing (single user digital version)

Sep 2014
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PDA TR 66 discusses single-use systems that are in either direct or indirect contact with raw materials, intermediates, and pharmaceutical drug substances or drug products and is intended to provide the reader with critical concepts or points to consider when implementing an single use system strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized small molecules and for bioprocesses that produce large-molecule biopharmaceutical products.
The document does not intend to discuss disposable items related to laboratory activities, final delivery system to the patient, transfusion bags, packaging, or medical devices.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Points to Consider for Single-Use System Manufacturing Strategy
  4. Single-Use Technologies and System Integration
  5. Qualification and Verification of Suppliers, Materials, Components, and Completed Assemblies
  6. Business Drivers for the Adoption of Single-Use Systems
  7. Implementation of a Single-Use System
  8. Appendix I: Overall User Requirement Specification Example
  9. Appendix II: Project Execution Plan Example
  10. Appendix III: Training Requirements Example
  11. References

Figures and Tables Index