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.

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.

The first WHO draft text on good manufacturing practices (GMP) was prepared in 1967 by a group of consultants at the request of the Twentieth World Health Assembly (resolution WHA20.34).

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.

The Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of the typical requirements for various validation studies. Validation of computerized

GMP guidelines published by WHO in 1992–2006 constitute in the first instalment an ongoing series of applications of the principles of GMP to various specialized areas. The series of the “main” GMP texts on the manufacture of pharmaceutical active substances and excipients, were approved by the WHO

good manufacturing practices (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1). This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14). The content of this

Quality assurance of pharmaceuticals: a compendium of guidelines and related materials: vol. 2: Good manufacturing practices and inspection, 2nd ed. World Health Organization. https://iris.who.int/handle/10665/43532. iv, 409 p.

2022年10月31日 · Good manufacturing practice (GMP) is that part of a quality management system to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.