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PDA TR 13-2-2020
Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products
This addendum complements the existing PDA TR-13 and is not meant to change or modify its content. The addendum provides recommendations for the development of an environmental control and monitoring program for classified areas and the associated GMP processes used for manufacturing operations requiring bioburden control in the biotechnology and pharmaceutical industries. The content includes a review of regulatory requirements and the development of risk assessments based on the criticality and complexity of processes, as well as industry examples of these risk-based approaches.
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Parenteral Drug Association [pda]