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Summary

该协议总结了在洁净室环境中最大限度地减少微生物生物负荷的最佳实践,并包括环境监测、过程监控和产品无菌测试等策略。它与需要满足当前良好组织规范标准和当前良好生产规范标准的制造和测试设施相关。

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