i hope i'm in the right forum, if not please forgive me.
we are currently in the process of designing and constructing a class 7 clean room.
I am looking for reading material on validation of clean rooms, performing IQ,DQ,OQ,PQ etc.
anyone knows a good source, or might have some pointers?
At a high level, Environmental Qualification for clean rooms in a GMP facility consist of the following:
- In-situ Studies to assess disinfectant procedures following construction
- Environmental Risk Assessment, Site Selection, and Disinfection Rational
- Environmental Qualification Execution and Final Report
- Facility Certification Validation Protocol and Final Report
- Post EQ Environmental Monitoring Program Development
- Development of Routine Environmental Monitoring Program (SOP)
As always, your terminology and exact document clustering may differ.