Lyophilizer Performance Qualification Protocol

The purpose is to describe the format and contents of the lyophilizer performance qualihcation protocol. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

The objective is to ensure that the freeze drying unit will operate and produce product quality results under load conditions. This will give a representation of long-term performance, verification of vendor guarantees for availability and failure rates, and a better debugged and more reliable system. 

Equipment name freeze drying unit — model All concerned equipment (list)  

Drying chamber with product shelf assembly 

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