The guts in the protocol design and style challenge is the look of the constant set of treatment procedures. We wish
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根据 cGMP 的要求，需要对制造设施进行适当的设计。确保它们遵守当地法规以及药品制造法规。
Temperature and relative humidity shall fulfill the necessity as laid out in the system specification.
The integrity in the HEPA filter shall be done According to The existing Model of SOP furnished by an authorized external agency.
The standard of the particulate count calculated at Just about every spot shall drop in or under The category limit.
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In the current methodology (by TOC or By HPLC) of analysis of residue written content, there will almost always be some residue attained in final result.
The commissioning system should really get started at the early levels of the task making sure that it could be built-in with system qualification treatments. We can offer Expert impartial total HVAC commissioning supported with commissioning protocol and execution of all actions, such as documented measurements of main HVAC system capacities, such as: Air duct leakage take a look at
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