PDA Technical Report No. 13 Revised 2022 (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)

Apr 2022
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This revision of TR 13 aligns with current industry trends and regulatory expectations and provides additional guidance and focus on increased expectations concerning data management and data integrity, qualification and maintenance of controlled environments, and rapid microbiological methods (RMM).

This technical report will aid in the establishment of an environmental monitoring program that is robust, meaningful, and practical while embracing innovation and the principles of quality risk management. Updates regarding microbiological and total airborne particulate control concepts and principles related to facilities involved in the manufacture of sterile pharmaceutical products and other designated cleanroom environments are also included.

While this TR may serve as a resource applicable for controlled environments in general, its primary focus is environmental monitoring for sterile product manufacturing.

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Format: PDF (1 file 1,253 KB)

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Environmental Classification: Regulatory Expectations  
  4. Environmental Monitoring Qualification Of Cleanrooms (Classified Areas) Used For Manufacturing and Filling of Sterile Products
  5. Environmental Monitoring Program 
  6. Environmental Monitoring by Manufacturing Application
  7.  Environmental Monitoring Prerequisites
  8. References

Figures and Tables Index

About the Authors