允许清单外的物品进入A/B区域是生产过程中可能存在的，按照EU GMP ANNEX1 4.12章节 以及GMP指南-无菌制剂 5.8章节 均有表述：

EU GMP ANNEX1 4.12：

ii. Material airlocks: used for materials and equipment transfer
ii.物料气锁:用于物料和设备转移。
Only materials and equipment that have been included on an approved list and assessed duringvalidation ofthe transferprocess should be transferred into the grade A or grade B areas via anairlock or pass-through hatches. Equipment and materials (intended for use in the grade A area)should be protected when transiting through the grade B area. Any unapproved items thatrequire transfer should be pre-approved as an exception. Appropriate risk assessment andmitigation measures should be applied and recorded as per the manufacturer's CCS and shouldinclude a specific disinfection and monitoring programme approved by quality assurance.

应仅允许包含在已批准清单中、在转移验证中评估的物料和设备通过气锁或传递窗转移到A级或B级区。当通过B级区转移时,设备和物料(预计用于A级区)应受到保护。任何需要转移的未获批物品应作为例外预先批准。应按照生产商的CCS,应用和记录适当的风险评估和缓解措施，包括经质量保证批准的特定的消毒和监测程序。

GMP指南-无菌制剂 5.8章节

对于需转移至 B 级或 A 级洁净区的物料，应建立经批准的物料转移清单，物料转移过程应经过验证，仅允许清单内的物品通过气闸或传递仓进行转移。如有清单外的物品需要被转移，则需进行额外的评估和批准。

经过评估和风险降低措施，并经QA部门批准后（以上均应是事前）是可以传入B级区的。