Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency …

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 …

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 …

2003年10月8日 · Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing …

2022年10月31日 · This document is a revision of WHO good manufacturing practices for sterile pharmaceutical products, previously published in the WHO Technical Report Series, No. 961, …

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 …

Good Manufacturing Practices (GMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards …

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 …

nd introducing the concept of a “quality unit”. During 2012 the Secretariat was made aware that the current Good manufacturing practices (GMP) for pharmaceutical products: main principles, …

2014年1月1日 · 欧盟GMP中强调的要求与WHO GMP相似，而中国新版GMP于2011年正式生效，两者既有相似之处，也存在一定差异。 本文将介绍并对比这两版GMP法规，以向制药企业 …