Standards, Regulations and Compliance

Table of Contents Australia’s pharmaceutical and medical device manufacturing sectors face increasing pressure to maintain the highest standards of cleanliness and contamination control. Product recalls, regulatory penalties, and market access restrictions represent significant risks for manufacturers who fail to meet current cleanroom classification requirements. The stakes have never been higher. Patient safety depends on the […]

Table of Contents Pharmaceutical cleanroom design is more than an engineering exercise. It’s a compliance obligation, an operational safeguard, and a strategic asset. For Australian manufacturers, meeting the expectations of the Therapeutic Goods Administration (TGA) and aligning with global benchmarks such as the FDA and EU GMP is fundamental to long-term viability. This article is