One of the services provided by PQE's Quality Engineering (QE) team is the GMP review.
The first step is to define and identify references to cGMP regulations within the facility that will be reviewed and assessed.
Whether at the design stage or in facilities that are already in operation, the GMP Review is essential to highlight and assess any critical issues that a layout and/or facility may have in terms of compliance with the relevant regulations.
The approach is to examine documents and drawings of the facility being reviewed and evaluated with particular attention to all GMP aspects.