U.S. Food and Drug Administration

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.

Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use. Many countries have legislated that manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

2024年7月26日 · Learn about GMP guidelines, how to uphold GMP standards, and technology for commercial and industrial good manufacturing practices (GMPs).

2003年10月8日 · Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (all language versions are available here).

World Health Organization Geneva 1997 GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION. VACCINE SUPPLY AND QUALITY. GLOBAL TRAINING NETWORK. A WHO guide to good manufacturing practice (GMP) requirements. Part 1: Standard operating procedures and master formulae. Written by:

2014年10月1日 · This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities.

2015年11月20日 · Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. Why is GMP important? Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.