PDA Technical Report No. 39 Revised 2021 (TR 39) Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment (single user digital version)

Oct 2021
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This technical report provides guidance for establishing a quality management system for distribution of all types of temperature-sensitive medicinal and pharmaceutical products. This guidance covers the shipping site, where the product is prepared for transportation, and the shipment of the product, from the product leaving the shipping site until its arrival at the receiving site where it will be stored or distributed to patient (end user). This Technical Report offers a resource for all involved stakeholders in the pharmaceutical supply chain, providing a model for qualifications from the process design through implementation and operation to verification.

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Table of Contents

Table of Contents:

Click here to download >>> Detailed Table of Contents
  1. Introduction
  2. Glossary
  3. Process Design
  4. Process Qualification
  5. Ongoing Process Verification
  6. Conclusion
  7. References
  8. Case Studies
  9. Additional Reading

Figures and Tables Index