Protocol

HVAC Operation Qualification Protocol

This protocol will be executed in compliance as per the requirements in 21CFR 210 & 211, ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001.

Upon final approval of this Protocol and Summary Report the system will be placed under formal change control in accordance with Company X Change Control Program summarized in Standard Operating Procedure DNAP/QM/012 entitled “Change Control System”.

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