Cleanroom Guidelines and Standards - Part 5 - Key differences & commonalities
And finally the last part!
We’ve reached the final instalment of our 5-part series on Cleanroom Guidelines and Standards! In this closing chapter, we focus on the key differences and commonalities across the leading regulatory frameworks governing pharmaceutical manufacturing.
We’ll examine how GMP Annex 1, PIC/S, ISO 14644, US FDA cGMP, ICH, and USP align and diverge in their approaches to cleanroom classification, monitoring, and design. Understanding these distinctions will empower professionals in the pharmaceutical and life sciences industries to navigate the complex landscape of global compliance, ensuring the highest standards of quality and safety.