ICHGxPstandarder

ICH GxP standards are a set of harmonized guidelines for good practice in pharmaceutical development, manufacturing, testing, and distribution, developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Humans Use (ICH). GxP stands for Good X Practice, an umbrella term for distinct areas such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Pharmacovigilance Practice (GVP). The aim is to ensure quality, safety, and efficacy of medicinal products while facilitating international regulatory convergence.

The guidelines provide technical expectations for activities across the product lifecycle, from preclinical testing through clinical development, production, quality control, packaging, distribution, and post-market surveillance. They are not laws themselves, but many national and regional authorities incorporate them into regulatory requirements, and compliance is often required for marketing authorization and inspections.

ICH was founded in 1990 by regulatory authorities and industry groups from the United States, the European Union, and Japan to harmonize technical standards. Its governance now includes additional member and observer regions. ICH periodically revises guidelines to reflect scientific advances; examples include ICH E6(R2) on GCP, ICH Q7 on GMP for active pharmaceutical ingredients, and ICH Q9/Q10 on quality risk management and the pharmaceutical quality system.

Industry actors such as pharmaceutical companies, contract research organizations, and contract manufacturers implement GxP standards to ensure product quality and to support global supply chains. Adoption varies by jurisdiction, but ICH GxP remains a widely recognized benchmark for good practice in the pharmaceutical sector.