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two. It is entire documented verification of the system that it works all through the process as per working ranges persistently.
Limitations ought to be established to the removing of any cleaning brokers utilized. Acceptance standards ought to consider the opportunity cumulative outcome of numerous things of equipment during the process equipment educate.
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The integrity with the HEPA filter shall be done as per the current Model of SOP supplied by an authorised external agency.
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The initial assertion in Just about every option is called a guard. The option can only be chosen In the event the guard is exe-
All check benefits should be calculated and noted to correspond With all the predetermined acceptance requirements.
In Polybius’ times, the trouble was to locate a great method for encoding and speaking an surprising
To allow us to structure protocols Within this manner, we want an unambiguous notation for expressing technique
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需要指出的是，尽管早期工艺设计不需要根据 cGMP的标准展开，但同样应在合理的科学原则指导下进行。应遵循良好的文档规范。特别是记录工艺开发与优化工艺中的数据、观察与结论。