由来自生物技术制造商的欧洲和北美专家、清洁化学品供应商、监管机构和咨询公司、PDA技术报告第49号撰写的专责小组撰写的，为生物技术清洁验证考虑清洁验证实践与生命周期方法验证的要点；由国际药物开发协调指南会议（Q8）、质量风险管理会议（Q9）和质量体系会议（Q10）启动。清洁验证在降低生物制药制造设备产品污染的可能性方面发挥着重要作用。 它表明，清洁过程能够充分且持续地去除清洁设备/系统中的产品残留物、工艺残留物和环境污染物，从而使该设备/系统能够安全地用于制造规定的后续产品（可能是相同的或不同的产品）。虽然生物技术制造业的清洁验证与其他制药制造业有许多相同的要素，但存在足够多的差异，因此，专门针对生物技术清洁验证的单独技术报告是合适的。 TR—49更新了以前的PDA清洁验证文件，包括1998 PDA技术报告第29号，清洁验证和1996个专著清洁和清洁验证的考虑点:生物技术的观点为生物技术制造商提供有价值的见解。

Written by an authoring task force comprised of European and North American experts from biotechnology manufacturers, cleaning chemical suppliers, regulatory agencies and consulting companies, PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation aligns cleaning validation practices with the life cycle approaches to validation, as enabled by the International Conference on Harmonisation guidelines on pharmaceutical development (Q8), quality risk management (Q9) and quality systems (Q10). Cleaning validation plays an important role in reducing the possibility of product contamination from biopharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the cleaned equipment/system, so that this equipment/system can be safely used for the manufacture of defined subsequent products (which may be the same or a different product). While cleaning validation for biotechnology manufacturing has many of the same elements as for other pharmaceutical manufacturing, there are enough differences such that a separate Technical Report focusing on biotechnology cleaning validation is appropriate. TR-49 updates previous PDA documents on cleaning validation, including the 1998 PDA Technical Report No. 29, Points to Consider for Cleaning Validation and the 1996 monograph Cleaning and Cleaning Validation: A Biotechnology Perspective provide valuable insights for biotechnology manufacturers.