As discussed in the Product Perspective, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of ...

Good Manufacturing Practice (GMP) is a system or protocol for ensuring product safety and consistency according to quality standards. GMP is important in all manufacturing industries, though it is ...

The course covers the need for and history of Pharmaceutical GMP as well as the key GMP requirements at the various parts of a pharmaceutical manufacturing site, from goods-in to despatch of the ...

In this webinar, Magdalena Pacewicz will highlight how to use AUC to characterize AAVs as part of ensuring regulatory ...

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

Like traditional biologics, cell and gene therapies (CGTs) must meet safety and efficacy standards before they can be administered to human patients. But the manufacturing processes used for this new ...

New Delhi: With thousands of small drug manufacturers struggling to meet tougher quality norms, the government is weighing a year's extension to the deadline for complying with the revised good ...