验证与确认 培训.ppt

* For large and complex projects, planning takes on added importance and separate validation plans may enhance clarity 对于大型的复杂项目，增加计划重点和独立的验证计划将有助于明晰要做的工作。 * * * * * * 附录第十一条 企业应当对新的或改造的厂房、设施、设备按照预定用途和本规范及相关法律法规要求制定用户需求，并经审核、批准。 3.2The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level.The URS should be a point of reference throughout the validation life cycle. * 供应商提供方案，用户审批 * 供应商提供方案，用户审批 * 3.3The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification. * * * 3.4 Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery. 设备，特别是结合了创新或复杂技术的设备，适用时，可以在供应商发货前进行评估。 3.5 Prior to installation, equipment should be confirmed to comply with the URS/functional specification at the vendor site, if applicable. 在安装之前，适用时，应在供应商的场所内确认设备符合URS功能性要求。 3.6 Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation. 在适当并经过论证的情况下，在FAT阶段或其他阶段可以对文件记录进行审核，及进行一些测试，如果可以显示这些功能不会收到运输和安装的影响的话，那么这些测试可以不需要在安装确认和运行确认时重复 * 3.7 FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site. 工厂验收测试FAT可以在生产场所接受设备后有现场验收测试SAT进行补充。 * “直接影响”系统是预期会对产品质量有影响的系统 ? “间接影响”系统是预期不会对产品质量有影响的系统 上述两种系统均需试车；而“直接影响”系统还需进行另外的确认行为。 * 3.9. IQ should include, but is not limited to the following: 安装确认应包括，但不仅限于以下内容： i. Verification