Contamination Control in the Pharmaceutical Industry
Particle Measuring Systems
33 episodes
8 months ago
Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
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Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).
The Continuous Monitoring Concept for Pharmaceutical Manufacturing
Contamination Control in the Pharmaceutical Industry
9 minutes 51 seconds
2 years ago
The Continuous Monitoring Concept for Pharmaceutical Manufacturing
Microbiologically controlled environments are crucial in the pharmaceutical industry to prevent contamination during aseptic processing. To ensure product and patient safety, continuous monitoring of viable and non-viable particles is essential, following Good Manufacturing Practice (GMP) requirements. The recent New Annex 1 published in August 2022 recommends adopting a continuous monitoring approach throughout critical processes.
Contamination Control in the Pharmaceutical Industry
Conversations focused on contamination monitoring and control, best practices, and meeting regulatory regulations (21CFR Part 11, EU GMP Annex 1, ISO14644-1, ISO 14644-2).