Historical
PDA TR 13-2014
Revised Fundamentals of an Environmental Monitoring Program
This document serves as a resource on controlled environmental test methods, and although some nonviable particulate information is included, the report’s primary focus is microbiological control for sterile product manufacturing. This document addresses international standards and regulatory guidances, elements of an environmental monitoring program, and environmental monitoring by application. Current guidelines for typical environmental monitoring frequencies and levels for pharmaceutical water are covered in the appendix.
CONTENT PROVIDER
Parenteral Drug Association [pda]
Parenteral Drug Association [pda]