Further to OQ – Operational Qualification
Importance of the Installation Qualification
- Documented proof that the installations, systems and plants in the installed or modified version correspond to the approved design and the manufacturer’s recommendations. (Aide Memoire GMP, inspection of qualification and validation in pharmaceutical production and quality control).
- Documented verification that installations, plants and equipment correspond to the approved design and the manufacturer’s recommendations in the form that they were installed or modified. (EC-GMP Guidelines, Annex 15)
- The basis of the IQ inspection is the status of the “Installations of the System” and their completeness.
- On the basis of the DQ - Design, the technical documents – diagrams – plans – parts lists, as well as the requirements specifications and the performance specifications, a completeness test is carried out and compared with the approved system. .
- Documentation of compliance with the DQ documents.
SEEFRIED Verfahrenstechnik GmbH supports you with the compiling of documentation and verification of the IQ – Installation Qualification.