GMP生产专用设备清洁验证规范要求
Generally speaking, when one thinks of cleaning validation, the first thing that comes to mind is “prevention of cross-contamination”, which obviously applies only when equipment is used for manufacturing more than one product. So why is cleaning validation talked about with regard to dedicated equipment? Section 12.70 of the guideline ICH Q7, states that, “Cleaning procedures should normally be validated. In general, cleaning validation should be directed to situations or process steps where contamination or carryover of materials poses the greatest risk to API quality…”
(2). Table I highlights the differences between the approach to clean shared and dedicated equipment.
一般来说，当想到清洁验证时，第一个念头就是“防止交叉污染”，这显然只适用于多产品生产所用的设备。那为什么还要对专用设备进行清洁验证呢？ICH指南Q7第12.70章说道：“一般需要对清洁程序进行验证。通常，在物料的污染或携带对原料药质量有最大风险的情况或工序应进行清洁验
证......”。表1给出了共用设备和专用设备清洁方法的不同。
For dedicated plants/equipment, there is no risk of cross-contamination among different active substances; nevertheless, a wide range of possible contaminants must be evaluated on a case-by-case basis (3), taking into consideration the type of process (i.e., chemical synthesis, extraction from natural sources, fermentation, physical steps, etc.), the final product, and the materials used during the manufacturing process (i.e., starting and raw materials, solvents, and reagents). As for cleaning validation of shared manufacturing plants, even for dedicated plants/equipment, it is necessary to identify all possible sources of contamination. Some key points to be considered are summarized in Table II.validation verification
对于专用厂区/设备，虽然没有不同原料药之间的交叉污染风险，但需要根据工艺类型（如，化学合成、自然来源提取、发酵、物理步骤等）、最终产品、生产工艺中所用到物料（如，起始原料、原料、溶剂和试剂）具体分析可能的污染物。对于共用生产厂区的清洁验证，即使是专用设备，也需要识别出所有的可能污染源。表II总结了一些关键考虑点。

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