•  The frequency of sampling and screening need to be minimized During this period immediately after effective completion of section I&II.

The cleanroom or cleanse zone shall meet the acceptance requirements for airborne particulate cleanliness.

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five. Prior to the stop of period I, system is initiated to function with some stress or tense disorders like commence of system immediately after failure of power or initiate just after emergency system shut down. System is simulated to function beneath typical scenario of routine maintenance like begin of system right after regeneration of resin, filter changing, ozone generator failure and so on. & in the final water system (Regular Running Technique )SOP’s made.

建立有据可循的 书面协议（prepared protocols）和 预期结果（expected outcomes）对于工艺确认非常重要。书面协议应包括 生产条件（production disorders）、 数据收集（data collections）、 测试（testings）和 取样计划（sampling strategies）。

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Shall overview the executed protocol to examine the compliance and corrective action for virtually any discrepancies located. Also shall prepare the summary and conclusion of the research

Reviewing and examining the HVAC qualification/requalification work is followed as per the normal operating procedure.

A PROMELA specification includes only three fundamental setting more info up blocks: information channels, processes and

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settle the main points of the implementation. We wish to defer choices on, As an illustration, concept format

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