PDA TR86-药品包装完整性测试的行业挑战和当前技术（中英对照）-202105.pdfVIP

PDA 86 技术报告第 号 药品包装完整性测试的行业挑战和当前技术 1.0Introduction 1.0 引言 For more than a decade, PDA Technical Report No. 27: Pharmaceutical Package Integrity served as an influentialreference document, representing the best practices in sterile product package integrity testing. At the time it was published, the information it presented was instrumental in shaping therevision of USP General Chapter 1207PackageIntegrity and TestMethod Selection (1, 2).As a result, the content of USP 1207 was expanded in 2016 and currently serves as the primary reference chapter focusing on the basics of package integrity andbestpracticesin sterileproductpackageintegrity evaluation andintegritytesting. The intent of USP 1207 isto guide package integrity development away from testing each sample at the smallest possible defect level, because quality cannot be tested into a product. Rather,using a risk-based approach and leveraging testing to better understand, analyze, and eliminate the risks during development phases is encouraged. Use of the appropriate testing during each manufacturing phase can help in evaluating and mitigating residual risks (i.e., in production/stability to proactively address risks/failure modes). Where feasible, regulations and quality risk management principles identified in ICH Quality Guideline Q9:Quality Risk Management shouldbeused(3). 十多年来，《PDA技术报告第27号：药品包装完整性》一直是有影响的参考文件，代表无菌 产品包装完整性测试的最佳实践。在出版时，它提供的信息有助于形成USP通则1207 《包 装完整性和测试方法选择》 （1,2）的修订。因此，USP1207的内容在2016年得到了扩展， 目前作为主要参考章节，重点介绍包装完整性的基础知识以及无菌产品包装完整性评估和完 整性测试的最佳实践。USP1207的目的是指导包装完整性开发，避免在尽可能小的缺陷水 平上测试每个样品，因为无法到产品中测试质量。相反，鼓励在开发阶段使用基于风险的方 法和利用测试来更好地理解、分析和消除风险。在每个制造阶段使用适当的测试有助于评估 和降低残余风险 （即，在生产/稳定性中主动应对风险/故障模式）。在可行的情况下，应使 用ICH质量指南Q9：质量风险管理中确定的法规和质量风险管理原则 （3）。 Subsequently, the PDA Package Integrity Technical Report Team reexamined the role of TR-27 and determined that a new technical report shouldbewritten,buildin