With the release of the new EU GMP Annex 1, a review of current practices is required to ensure that the installed monitoring system, chosen to meet the needs of Annex 1, complies with the requirements. This chapter will review the needs of Annex 1 with systems designs currently being installed.
To satisfy the assurances required by regulatory agencies, pharmaceutical products are manufactured in a controlled environment. Cleanrooms are an example of a controlled environment and are employed to reduce the contamination risk and variability of
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.