QHS021

The ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The World Health Organization (WHO) good manufacturing practices

ICH Q7 is a document that provides guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs). It also aims to ensure that APIs meet quality and purity requirements. ICH Q7 defines 'manufacture' as all operations related to the receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage, and distribution of APIs and related controls. The latest version of the ICH Q7 'How to do' document was finalized in July 2022 and published on the APIC (Active Pharmaceutical Ingredients Committee) website at the end of October. Good Manufacturing Practices (GMPs) are systems that ensure that products are consistently produced and controlled according to quality standards. They are designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product. GMPs consist of processes, procedures, and documentation. The five key elements of GMPs are: Products and primary materials Premises and equipment People Procedures Processes CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilitie