The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing ...
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has adopted new guidelines on cross-contamination in shared facilities and implemented revisions to several of the sections in its good ...
Continuous monitoring systems support regulatory compliance through automated environmental tracking and real-time alert capabilities.
Food safety has been regulated across the world for as long as large-scale food production has been in place – since the mid-1800s in the United States, for example. Resulting from a long history of ...
A revision of the EU GMP Volume 4 Annex 1 was issued in August 2022, introducing new regulations for sterile drug products and production. This release replaced the 2020 draft and 2008 version, adding ...
As a background summary, CGMP represents the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMP guidelines provide for systems that give ...