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Elevated temperatures can reduce the efficacy of pharmaceutical products. Transportation poses a chance of temperature fluctuations thanks to various factors, making it needed to validate all the transportation process.

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Air velocity measurement shall be executed as per The present Model of SOP furnished by an authorised exterior company.

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A well created Heating, Ventilation and Air-Conditioning (HVAC) system play a vital position in ensuring the manufacture of quality pharmaceutical and microelectronic solutions and can even provide at ease situations for operators or any staff that remaining in (or passing by means of) the realm equipped with air from HVAC system.

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Whilst executing Every single action, documentation of your required facts shall be completed in the suitable attachment of the protocol.

持续工艺验证涉及在商业产品生产过程中的持续验证，以确保在先前阶段设计和确认的工艺能够按照期待的那样继续提供一致的产品质量。这是一个生命周期管理（lifecycle administration）的范畴。

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A cleaning validation protocol cum report addressing the cleanliness of each bit of equipment shall be generated following the compilation of three batch validation.

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