Achieving EU Veterinary GMP compliance is essential to ensure the safety, quality, and effectiveness of veterinary medicinal products. PQSL partners with organisations to establish and strengthen quality systems aligned with... Read More
Author: paulrpalmer
The updated ICH Q9(R1) guidelines emphasize data-driven FMEA risk assessments in the pharmaceutical sector, reducing reliance on subjective judgment. By using historical data, measurable criteria, and continuous risk reviews, organizations... Read More
Single-Use Technology (SUT) is transforming biopharmaceutical manufacturing with improved flexibility and reduced cleaning requirements. However, it introduces risks such as extractables and leachables, chemical migration, sterility breaches, and supply chain... Read More
A strong Pharmaceutical Quality System (PQS) is essential for maintaining regulatory compliance and ensuring consistent product quality across pharmaceutical operations. It provides a structured framework aligned with Good Manufacturing Practice... Read More