Articles

The implementation of EU GMP Annex 1 in Practice

Explore the transformative changes in sterile pharmaceutical manufacturing with the revised EU-GMP Annex 1 (2022), emphasizing a Pharmaceutical Quality System and Contamination Control Strategy. This blog post delves into the Cleanroom Design Implications, highlighting shifts in ISO 5 classification and particle size requirements, urging a high-level gap assessment for seamless integration, and promising in-depth insights into practical implementation in upcoming blogs.

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NATASA STIRN