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PDA TR 13-2022
Fundamentals of an Environmental Monitoring Program
This document was created to aid in the establishment of an environmental monitoring program that is robust, meaningful, and practical whilst embracing innovation and the principles of quality risk management. This revision updates microbiological and total airborne particulate control conceptsand principles as they relate to facilities involved in the manufacture of sterile pharmaceutical products and other designated cleanroom environments.
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Parenteral Drug Association [pda]