Thisquestions and answers paper is a follow up to the webinar, “ISO 14644-2:2015 Cleanroom Monitoring”. Many questions were asked about cleanroom practices and the most recent to the ISO standard. Questions submitted during and after the webinar are answered below.
This paper discusses the use of active air and passive air settle plate monitoring for routine and continuous pharmaceutical manufacturing. Scientific literature supporting settle plates and active air sampler monitoring effectiveness is evaluated to support the transition from passive to active air monitoring.
This document discusses the current regulatory standards for viable environmental monitoring (EM) in the pharmaceutical industry. Updates to the European Union (EU) Good Manufacturing Practice (GMP) Annex 1 are analyzed to better understand the industry’s future trends and possible changes in other guidances.
Originally published for ISCC 2018 Netherlands.
A quality risk management (QRM) approach provides a holistic way to manage EM risks in a facility. Locations, sampled during room/equipment qualification, are evaluated during a risk assessment to identify the areas at greatest risk of introducing particulate or microbial contamination. Once these areas are identified, risk reduction activities can be conducted to concentrate sampling at those high-risk locations.