Installation qualification
The Installation Qualification ( IQ ) documents the correct implementation of the previously defined requirements (e.g. in the Design Qualification , DQ) when setting up and installing the system supplied. By the IQ ensures that the plant according to the user's requirements and thus according to specification ( of burdens and specification has been set up) and a sufficient documentation as a record exists for it.
General activities
The activities during the installation qualification and the existing or to be created documents are, for example:
- Inventory and inventory of the delivered components as well as a check against the order documents
- Checking the assembly based on the piping and instrumentation schemes (R&L scheme, isometry) and other binding plans
- Compilation of the documentation and cataloging of the manuals
- Creation of a measuring, control and regulation technology point list (MSR point list) and determination of the quality-relevant measuring points. The measuring devices must be provided with measuring point numbers for clear identification
- Checking the calibration capability of the MSR points. It is checked whether the measuring elements are accessible and removable
- List of computerized system components
literature
- Qualification and process validation of the company "Muster" for pharmaceutical manufacturers, BAH Bonn (3rd edition 2006)