PDA发布第29号原始技术报告已经14年了，清洁验证在降低制药设备产品污染的可能性方面继续发挥着重要作用。清洁验证表明，清洁过程充分且持续地从制造设备/系统中去除产品残留物、工艺残留物和环境污染物，以便该设备/系统可安全用于制造指定的后续产品（可能是相同的或不同的产品）。2012年修订的《29号技术报告》以1998年的报告为基础，采用了2010年PDA号技术报告中的原则和具体措辞。 49点，考虑生物技术清洗验证。它提供了与验证的生命周期方法和国际协调会议（ICH）指南Q8（R2）-药物开发，Q9-质量风险管理和Q10-药物质量体系一致的最新信息。此外，本报告旨在帮助希望为其设备和设施创建或基准清洁验证计划的读者。该报告由一个由来自制药制造商、清洁化学品供应商和咨询公司的欧洲和北美专业人士组成的工作组撰写，并经过了全球技术同行审查，以确保提出的概念、术语和实践反映了可靠的科学，并可在全球范围内使用。

It has been 14 years since PDA published the original Technical Report No. 29, and cleaning validation continues to play an important role in reducing the possibility of product contamination from pharmaceutical manufacturing equipment. Cleaning validation demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the manufacturing equipment/system, so that this equipment/system can be safely used for the manufacture of specified subsequent products (which may be the same or a different product). The 2012 revision of Technical Report 29 builds on the 1998 report and utilizes principles and specific wording from the 2010 PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation. It presents updated information that is aligned with lifecycle approaches to validation and the International Conference on Harmonisation (ICH) guidelines Q8 (R2) - Pharamaceutical Development, Q9 - Quality Risk Management and Q10 - Pharmaceutical Quality System. Also, this report aims to assist readers who want to create or benchmark a cleaning validation program for their equipment and facilities. Written by a Task Force composed of European and North American professionals from pharmaceutical manufacturers, cleaning chemical suppliers, and consulting companies, the report has undergone a global, technical peer review to ensure concepts, terminology, and practices presented are reflective of sound science and can be used globally.