本技术报告的目的是概述控制和评估使用全部或部分手动程序的药品/医药产品无菌加工操作的方法和途径。本技术报告对可能进行手动无菌处理的医院和配方药房有价值。本报告中提供的指导可能适用于以下操作:疫苗制备、细胞培养、基因治疗、研究性新药/IMP制造、临床和商业制造，以及药物配方和配药。 本报告的目的并不是为了解决在自动灌装过程中进行的简短、相对罕见的人工干预。例如，从灌装线上取下倾倒的小瓶或获取用于灌装重量检查的容器，在安装过程中进行无菌连接，在生产线停止时进行纠正活动，等等。

The purpose of this technical report is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. This technical report has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, Investigational New Drug/IMP manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing. This report is not intended to address the brief, relatively infrequent, human interventions into an otherwise automated filling process. Examples include reach-ins to remove a toppled vial from the filling line or to obtain a container for a fill-weight check, aseptic connections made during set-up, corrective activities during line stoppages, and so on.