2. About Good 'x' Practice (GxP)


1. About Good 'x' Practice (GxP)

1.1. GxP Regulatory oversight

Different countries/regions have their own defined GxP rules and guidelines, enforced and audited by the respective regulatory authority, and particular GxP criteria covering specific topics can be found in legislation and guidelines and also industry best-practice frameworks. Nevertheless, the fundamental concept and requirements of GxP are similar across countries/regions; they have almost uniformly been adopted by government agencies, e.g., related to product manufacturing processes, documentation procedures, staff qualifications and training, distribution, etc.

In the EU, GxP regulations are defined in the European Commission[1] EudraLex[2]. In the US, GxP regulations in the Food & Drug Administration (FDA) Code of Federal Regulations (CFR) Title 21[3] or in Japan; in the Japan’s Ministry of Health, Labour and Welfare (MHLW) “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (abbreviated the PMD Act[4]). In many countries, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) GMP[5] and the ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) guidelines[6] are adapted.

The respective regulatory authorities are: the European Medicines Agency (EMA) for Europe, the FDA for the USA, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

It is nevertheless important to note that national guidelines can have a major impact on companies beyond borders. Regulators running GxP inspections in other jurisdictions expect that their own standards are followed. The proliferation of mutual recognition agreements, such as that between the U.S. and the EU, means that what appear to be local GMP issues can quickly become international. Local breaches of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) can mean that the results of non-clinical and clinical studies become ineligible for submission to regulators in any jurisdiction. Therefore, companies need to comply with differing standards of Good Pharmacovigilance Practice (GVP) from another jurisdiction.