2023年6月13日 · What is meant by CCS? The current Annex 1 (version of 22/08/2022) of the EU GMP Guide marks a paradigm shift in the rules and regulations of Good Manufacturing Practice (GMP). The focus is on a more risk-based and holistic approach. For the first time, a comprehensive and overarching contamination control strategy (CCS) is required.

2024年2月8日 · In this article I have described a path that can drastically enhance the likelihood of long-term sustainable cGMP compliance. It requires a focus on the 4Cs- Compliance, Culture, Competencies, and Capacity.

2022年12月9日 · EUの「GMPガイダンス アネックス1」 (PIC/Sのアネックス1も同じ内容)が改訂され、「汚染管理戦略 (CCS：Contamination Control Strategy)」と呼ばれる、汚染対策の包括的な戦略の策定が求められている。

简单来说，GMP 认证是 “良好作业规范” 或 “优良制造标准” 认证 ，英文是 “Good Manufacturing Practice”，是一套适用于制药、食品、化妆品、医疗器械等行业的强制性标准。 GMP 认证要求企业从原料、人员、设施设备、生产过程、包装运输、质量控制等方方面面，按国家有关法规达到卫生质量要求，形成一套可操作的作业规范。 它就像是一个严格的 “生产质量管家”，时刻监督着企业的生产流程，目的是确保最终产品质量符合法规要求，保障消费者的健康和安全。 比如制药 …

2023年8月4日 · 01 什么是污染控制策略（CCS）EU GMP附录1对于CCS进行了明确的定义：“A planned set of controls for microorganisms, endotoxin/pyrogen and particles, derived from current product and process understanding that assures process performance and product quality.” “污染控制策略是源于对当前产品和工艺的理解、用于确保工艺性能和产品质量的一系列有计划的措施，这些措施是针对微生物、内毒素/热原和微粒的控制。

GMP是英文 Good Manufacturing Practice 的缩写。直译为“优良的生产实践”，由于Manufacture一词包含生产和质量管理双重含意，加之，在国际上GMP已成为药品生产和质量管理的基本准则，是一套系统的、科学的管理制度，所以译成“药品生产和质量管理规范”更接近原文 ...

2025年2月10日 · In what is known as the 4 C's of food safety, the foundation of more technical food safety practices can be covered. The components of this concept can significantly protect every customer from foodborne illnesses and other risks of food hazards.

2024年7月27日 · In the food industry, ensuring the safety and quality of food products is paramount to protecting consumer health, upholding regulatory compliance, and safeguarding brand reputation. The four Cs are fundamental principles that form the backbone of safe food handling practices.

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.

2023年7月25日 · In this blog, we will explore the significance of the 4Ps and 4Cs in the pharmaceutical industry and how they contribute to building a successful marketing strategy. The 4Ps in Pharmaceutical...