Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks …

Jun 26, 2025 · GMP refers to the Good Manufacturing Practice regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and …

The ICH Q7 guideline provides details of Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API). It is a guideline adopted globally for applying GMP to APIs …

The Code of Federal Regulations (CFR) states that "Training in current good manufacturing practice [CGMP] shall be conducted by qualified individuals on a continuing basis and with …

Good Manufacturing Practice guidelines. Links to resources in Australia, Canada, European Union, Japan, USA and the World Health Organization.

The Supplier Guide, or GAMP Version 1.0 as known today, was published in electronic format in March 1995. 1 It addressed expectations from the US FDA and the European Commission’s …

Featured Guidance Documents Good Practice Guide: Continuous Manufacturing of Biological Products Just Published - Whether you are exploring continuous biomanufacturing (CBM) for …

This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic …

This ISPE GAMP ® Guide: Artificial Intelligence is the single source for a holistic interpretation on effectively developing and using AI-enabled computerized systems in GxP areas, while …

Disclaimer This GMP audit checklist is intended to aid in the systematic audit of a facility that manufactures drug components or finished products.