In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.
A Contamination Control Strategy (CCS) identifies and evaluates contamination risks, explores mitigation options, and sets out plans for corrective and preventive actions. Its implementation addresses ...
A CCS is mandated by EU and US regulations and ICH guidelines to ensure product safety and compliance in pharmaceutical manufacturing. Key CCS elements include monitoring, validation, contamination ...
In this free webinar, see how environmental monitoring in pharma supports contamination control, inspection readiness and a demonstrable state of control. Attendees will learn how to design a ...
The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...
The EU GMP Annex 1 revision has indicated that each company has a contamination control strategy. But what does such a strategy look like? What are the core elements? And how can risk assessment be ...