Good Clinical, Laboratory, and Manufacturing Practices - GxP

GxP refers to the various regulations and guidelines governing "good practices" for organizations involved in the manufacturing of products for human or animal use, including medical, cosmetic, tobacco, and food products. The "x" in GxP represents a broad range of processes used in the development, production, and distribution of regulated products, such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Storage Practices (GSP), and more.

GxP regulations are defined by different industry-specific regulators. For example, the Food & Drug Administration (FDA) in the USA, the European Medicines Agency (EMA) in Europe, the UK Medicines & Healthcare Products Regulatory Agency, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Consequently, each country or region may have its own set of GxP regulations and guidelines. Specific GxP criteria can be found in government agency regulations and guidance, such as the Federal Food, Drug, and Cosmetic Act, as well as industry best-practice frameworks. Global life sciences organizations conducting business in the US typically find GxP requirements in the US FDA Code of Federal Regulations ("CFR"), in Europe, in the Eudralex EU Pharmaceutical Legislation, and in Japan, in the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

Atlassian's Cloud offers administrative, physical, and technical controls that assist life sciences customers in achieving their quality, documentation, and security objectives. In addition to managing the underlying infrastructure and operations, Atlassian Cloud products provide features that facilitate compliance with applicable GxP requirements.

As a Cloud Service Provider, Atlassian fulfils many of the regulatory requirements pertaining to the security and quality of electronic records and signatures (ERES) through independent, third-party compliance validation programs like ISO/IEC 27001 and ISO/IEC 27018.

Our GxP outsourcing guidance white paper offers specific mappings to each requirement and how Atlassian Cloud Enterprise assists you in meeting your obligations, including Atlassian’s compliance offerings, the right to issue instructions, data security, termination, and chain outsourcing. To learn more about our commitment to safeguard customer data, visit our Security Practices page.

For more information, contact us.