With the inclusion of cleanroom validation and qualification in the flexible and scientifically sound pharmaceutical processes proposed by the new Annex 1 revision, an overall review of pharmaceutical development is essential. The aim of pharmaceutical development is to design a quality product and a manufacturing process to consistently deliver the intended performance of the final product.
Thisquestions and answers paper is a follow up to the webinar, āISO 14644-2:2015 Cleanroom Monitoringā. 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.