PDA Technical Report No. 66, (TR 66) Application of Single-Use Systems in Pharmaceutical Manufacturing (single user digital version)
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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:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Points to Consider for Single-Use System Manufacturing Strategy
- Single-Use Technologies and System Integration
- Qualification and Verification of Suppliers, Materials, Components, and Completed Assemblies
- Business Drivers for the Adoption of Single-Use Systems
- Implementation of a Single-Use System
- Appendix I: Overall User Requirement Specification Example
- Appendix II: Project Execution Plan Example
- Appendix III: Training Requirements Example
- References
Figures and Tables Index