All pharmaceutical and biotech products must be manufactured in accordance with the current Good Manufacturing Practice (cGMP) regulations. Environmental monitoring of these pharmaceutical manufacturing areas meets the requirement for contamination control of an environment, which is essential in defining clean manufacturing and demonstrating the necessary controls are working.
Pharmaceutical products are manufactured to meet exacting standards of both efficacy and quality. All aspects of quality are reviewed considering the risks associated with the delivery method (injected, ingested etc.) and the manner in which they were produced (aseptic, terminally sterilized, or under lesser controlled conditions). This paper looks at two parts of that process: the quality of the environment in which the product is manufactured and the standards that surround the particle concentration limits that determine what a controlled environment consists of.
The Environmental Monitoring Handbook for Pharmaceutical Manufacturers covers particle counting technology, regulatory standards in pharmaceutical manufacturing, and the instrumentation and techniques required for compliance. It offers a holistic and in-depth understanding of Environmental Monitoring (EM).
Annex 1 2008 is the basis for the 2022 version. This paper provides an easy-to-understand side by side comparison of the Annex 1 2008 v. 2022 versions, broken down by section.
