PDA TR29_清洁验证要求_Cleaning Validation_1998.pdfVIP

1. Introduction 简介 1.1Background 背景 In recent years, cleaning has achieved a position of increasing importance in the pharmaceutical industry. The current good manufacturing practices (CGMP) regulations recognize that cleaning is a critical issue to ensure product quality. Virtually every aspect of manufacturing involves cleaning, from the initialstages of bulk productiontothefinaldosageform. 近年来，清洗步骤在制药行业逐渐发挥着重 CGMP 要作用。现行良好生产规范 （ ）认为清洗是确保产品质量的关键步骤。事实上，生产的每方面，从 原料药生产的最初阶段到最终剂型都涉及清洗。 The CGMPs in the United States, Europe and other parts of the world have provided the pharmaceutical industry with general guidance for cleaning requirements. For example, in the U.S., section211.67 of part 21of the Code of Federal Regulations (CFR) states that Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contaminationthat would alter the safety, identity,strength,quality,or purity of the drug product beyond the official or other established requirements. Section 211.182 of part 21 of the CFR identifies that cleaning procedures must be documented appropriately, and that a cleaning and use log should be established. In addition to CGMPs, various inspectional guideline documents published by the FDA contain expectations regarding cleaning in the pharmaceutical industry. Cleaning is also addressed in the PIC recommendations on cleaning validation and in the SFSTP Commission report Validation des procedesde nettoyage. 美国、欧洲和其他CGMP已提供了制药行业清洗要求的通用指南。例如在美国， CFR 21 211.67 联邦法规 （ ）的第 部分第 节说明“设备和器皿应在合适的时间段进行清洗、维护和灭菌，防 CFR 21 止故障或污染导致药品安全性、均一性、效价、质量或纯度超过官方或其他规定的要求”。 第 部分 211.182 CGMP FDA 的第 节规定清洗程序必须合适记录，应建立清洗和使用记录。除了 ，