2025年1月21日 · CGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength,...

U.S. Food and Drug Administration

Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

Good manufacturing practices for drugs. Good manufacturing practices (GMP) are part of quality assurance. They ensure that drugs are consistently produced and controlled. Drugs must meet the quality standards for their intended use—as outlined in the marketing authorization, clinical trial authorization or product specification.

2024年12月5日 · Key requirements for drug manufacturing quality include relevant provisions of the FD&C Act and FDA’s current good manufacturing practice (CGMP) regulations.

(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals.

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.

gmp：药品生产质量管理规范，gmp全称（good manufacturing practices），中文含义是“生产质量管理规范”或“良好作业规范”、“优良制造标准”。 GMP要求制药、食品等生产企业应具备良好的生产设备，合理的生产过程，完善的质量管理和严格的检测系统，确保最终 ...

The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.

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 involved in any pharmaceutical production that cannot be …