设备及设施管理是质量体系六大版块之一，每个cGMP药厂生产及运营的重要组成部分。涉及面非常广，在确认完成投入使用后，设施设备日常使用发生各种问题的维护和维修，需要建立一支符合cGMP及专业性强的团队才能完成。如果某一环节出现问题，则无法确保药品的质量，甚至会影响到企业的经营。
为了提高设备日常应用效率，排除实际工作中种种困惑与难题，降低企业的运行和合规风险。针对相关问题进行深入解析。从法规（cgmp、fda、eu、who）基础信息，再从风险分级角度如何开展整个设施设备维护维修，再重点从5个实际案例为主线，讨论前期管理（选型、采购、安装）严重影响着产品质量；生产过程中强调全员参与设备管理(TPM)，选择合适的生产线硬件、增强操作工、维修工的实际应用技术水平，提高设备综合效率、节能减排，使设备处于最优状态，生产质量均一的产品。在确认与验证过程中出现的偏差进行调查、评估，采取相应的纠正措施和预防措施（CAPA)，设备技术指标得到提升，符合产品和工艺需求的参数要求，降低风险（异常跑料、环境污染等）。
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希望这篇文章能起到个抛砖引玉的作用（有玉的尽管砸过来），如果有什么问题请留言。希望生产工程设备的数据完整性（DI）符合注册工艺参数及运行条件。
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