Cleanroom Guidelines and Standards - Part 2 PIC/S & ISO14644
Following the introduction to cleanroom standards, we continue our exploration of key guidelines that shape the pharmaceutical and healthcare industries. Our next focus lies on the PIC/S guidelines & ISO14644 and their impact on cleanroom practices.
𝗣𝗮𝗿𝘁 2 – PIC/S & ISO14644
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) promotes global harmonization of GMP standards to ensure the quality, safety, and efficacy of medicinal products.
Aligning with ISO 14644-1, PIC/S guidelines cover cleanroom design, air quality, and construction materials to prevent contamination. They emphasize continuous monitoring, real-time technologies, and strict personnel hygiene protocols.
While GMP Annex 1 focuses on sterile products in Europe, PIC/S provides a broader, globally applicable perspective for various drug types and manufacturing practices.
This publication is the second part in our 5-part series on Guidelines & Standards.
Stay tuned for more insights into quality assurance and innovation in pharmaceutical manufacturing.