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Right documentation of commissioning is an essential Component of the productive validation of pharmaceutical water system. Commissioning involves the startup with the water system with documenting the general performance of all system parameters.
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Air velocity measurement shall be carried out According to The existing version of SOP supplied by an approved exterior company.
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工艺验证是一个循序渐进的过程，旨在确保制造工艺能够始终如一地生产出优质产品。它由制药行业制造商的质量保证负责人领导的验证团队执行。尽管严格意义上的工艺验证包括工艺设计的阶段，但在实际操作中，工艺验证通常是在发布新产品之前进行的。在开始时建立的工艺验证协议（validation protocol）应明确规定如何执行验证过程，包括要监控的参数、要采集的样本和接受的结果标准。需要注意的是，在商业化生产之前，制造商应该确认产品能够满足所需的质量标准，并且设计的生产工艺满足安全性和有效性相关的要求。
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Our validation specialists assistance you to definitely determine validation demands and the suitable testing scope for all filters and SUS.
The commissioning program should really start within the early levels of the project to make sure that it might be integrated with system qualification processes. We can offer Expert impartial comprehensive HVAC commissioning supported with commissioning protocol and execution of all routines, together with documented measurements of primary HVAC system capacities, for example: Air duct leakage exam
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tackle these details, let us 1st try to answer a far more basic concern: what specifically ought to a protocol
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