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PDA Technical Report Distribution Series

PDA Technical Report Distribution Series

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PDA Technical Report Distribution Series — A Compilation of Technical Reports on Supply Chain

PDA has organized the five most relevant technical reports about the supply chain distribution, covering testing to the last mile, in a convenient series. Now you can own all five of them in one easy-to-use file at a reduced price. This compilation is sure to be an invaluable guide for you as you navigate the scientific and regulatory aspects of supply chain distribution.

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Format: PDF (1 file 2.10 MB)

Table of Contents:

PDA Technical Report 39

1. Introduction
2. Glossary
3. Principles of Qualification for Transport
4. Product Stability Profile
5. Transportation Process Flow Considerations
6. Design and Development
7. Operational and Performance Qualification Testing
8. Process Implementation and Training
9. Quality Systems
10. Handling
11. Conclusion
12. Global Regulations and Pharmacopoeial Standards
13. Publications from Official Bodies
14. Tables

PDA Technical Report 46

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Introduction
Glossary of Terms
Distribution of Temperature Sensitive Pharmaceutical Products
Education to Provide End User/Recipient
Conclusion
Appendices
References

PDA Technical Report 52

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  1. Introduction
  2. Glossary of Terms
  3. Requirements
  4. Appendix
  5. Additional Reading
Figures and Tables Index

PDA Technical Report 53

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  1. Introduction
  2. Glossary of Terms
  3. Drug Product
  4. Bulk Drug Product
  5. Clinical Trial Materials
  6. References
  7. Figures and Tables Index

PDA Technical Report 58

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  1. Introduction
  2. Glossary of Terms
  3. Temperature-Controlled Distribution Management
  4. Risk Assessment
  5. Risk Control
  6. Risk Review
  7. Appendices
  8. Additional Reading
  9. References
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