Installation Qualification (IQ)

The term Installation Qualification largely aligns in meaning and nature with the concept of an inventory or checklist. At this stage, the equipment/systems are inspected in an off (non-operational) state. In addition to the equipment/systems themselves, the completeness of the required technical documentation is also checked, including the presence of necessary passports, test reports, certificates, etc., including calibration certificates for measuring instruments installed in the equipment.

EU GMP Guidelines Annex 15: Qualification and Validation provides the following definition of Installation Qualification (IQ):

“Installation Qualification (IQ): The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer's recommendations.”

Annex 15 also defines the following requirements regarding Installation Qualification (IQ):

“…3.8. IQ should be performed on equipment, facilities, utilities, or systems.

3.9. IQ should include, but is not limited to the following:

i. Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications;

ii. Verification of the correct installation against pre-defined criteria;

iii. Collection and collation of supplier operating and working instructions and maintenance requirements;

iv. Calibration of instrumentation;

v. Verification of the materials of construction…”

Installation Qualification (IQ) can only be conducted after the successful completion of Design Qualification (DQ). The verification is carried out based on a pre-prepared qualification protocol with control points and predefined acceptance criteria, typically formatted in a table. Before the qualification is conducted, the protocol must be approved for use, and no changes to the wording of control points and acceptance criteria are allowed during the qualification process.

During the verification, the protocol is filled out, and after checking all control points, a qualification report is prepared, which may either be the completed qualification protocol or a report formatted as a separate document.

The specialists at Tarqvara Pharma Technologies have years of experience in conducting qualification, validation, and acceptance tests within the pharmaceutical industry, in full compliance with international, European, and national GMP/GxP regulations and standards.