Bryan O’Donnell, Head of Quality at Gaelic Laboratories, explains how to navigate GMP challenges to ensure your company ...
Mary Kay Bates, senior global cell culture scientist at Thermo Fisher Scientific, explores best practices for implementing ...
Now FDA on-site inspections have resumed ... two years older and at threat of not complying with GMP standards. On top of this, some regulations have changed, plunging more facilities into ...
Ensure calibration and maintenance of equipment are conducted regularly and implement risk-based validation protocols aligned with FDA expectations. 4. Train employees on GMP guidelines ...
By Joachim Leube, Bayer HealthCare Manufacturing, Italy New options of therapy are needed for a considerable number of diseases.
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation ...