Good manufacturing practice - Wikipedia
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.
Current Good Manufacturing Practice (CGMP) Regulations
The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
What is GMP | Good Manufacturing Practices - SafetyCulture
2024年7月26日 · GMP, which stands for Good Manufacturing Practices, is a system that ensures that manufactured products—such as food, cosmetics, and pharmaceutical goods—are consistently produced and controlled according to set quality standards. Implementing GMP can help cut down on losses and waste, and avoid recalls, fines, and jail time.
Good Manufacturing Practices - World Health Organization …
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 practice - European Medicines Agency (EMA)
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.
良好生产规范 - 维基百科，自由的百科全书
《良好生产规范》（英語： Good Manufacturing Practice，GMP）是指 食物 、 药品 、 医疗器械 、 化妆品 等生产和质量管理的法规 [1]。 世界卫生组织 于1975年11月正式公布GMP标准，台灣亦將之納入管制規範 [1]。 国际上药品的概念包括兽药，只有 中華人民共和國 和 澳大利亚 等少数几个国家是将人用药GMP和兽药GMP分开的。 除去GMP，还有多种 GxP （英语：GxP） （“良好某某规范”）。 中国大陆. 目前，中国大陆血液製品、粉針劑、大容量注射劑、小容量注射劑生產 …
Facts About the Current Good Manufacturing Practice (CGMP)
The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. Consumers expect that each batch of...
Good Manufacturing Practice (GMP) Resources - ISPE
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 eliminated through testing the final product. GMP covers all aspects of production from the starting ...
Medicines: Good manufacturing practices - World Health Organization …
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 can damage health. GMP helps boost pharmaceutical export opportunities. What is GMP? Is GMP necessary if there is a quality control laboratory?
TRS 986 - Annex 2: WHO good manufacturing practices for …
2014年10月1日 · Overview. Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the ...