Understanding installation qualification
The Installation Qualification (IQ) process verifies that the newly installed clean room and equipment meet the requirements of the User Requirement Specification (URS). IQ is important because installation errors can compromise the performance of the facility.
The IQ process consists of a step-by-step series of verification protocols to ensure that each component of the clean room has been installed correctly.
At the end of IQ, the aseptic suite is ready for Operational Qualification (OQ) to begin.
Defining the IQ protocol
The IQ protocol is usually written by the contractor, but the user must approve it and be assured that the qualification meets the requirements specified in the URS.
The IQ protocol forms part of the Validation Master Plan (VMP). Further information on the VMP can be found in the article on understanding clean room qualification (SPS page).
Support from your GMP advisor or a third-party validation expert is advised.
Pre-requisites before starting IQ
In addition to the IQ protocol, the following must all be in place before starting IQ.
IQ team
Personnel involved in the execution of IQ must be named in the protocol. The team may include:
- Production manager / Accountable Pharmacist (if Section 10 unit)
- Head of Quality Assurance
- Chief Pharmacist
- Estates Lead
- third party validation specialist
- GMP advisor
- contractor/builder
Refer to the article about assembling a clean room design and build team (SPS page) for further guidance.
Pre-requisites
Define and document the perquisites within the protocol in advance.
Design Qualification (DQ)
Design Qualification (DQ) must be completed and approved before IQ begins. Verify that all technical drawings, electrical wiring diagrams and schematics are approved and available. For further details refer to the article about design qualification (SPS page).
Factory Acceptance Testing (FAT)
Factory Acceptance Testing (FAT) may be required for some components and equipment. FAT comprises functional tests against the design specification and is performed on significant items of equipment at the supplier’s premises before they are shipped to the user’s site. This will require on-site visits or review of video images taken during FAT.
Contractor documentation
Ensure manuals, installation guides, and maintenance schedules from equipment suppliers are available.
Component delivery
Verify that all equipment, utilities, and materials have been received and inspected for damage.
Undertaking IQ
IQ should be performed by the contractor or by a third-party validation specialist working independently on behalf of the user. The user, or a GMP expert, working on their behalf should witness the testing.
Scope of IQ
IQ protocols cover all aspects of the build including, but not limited to, the following.
Structural installation
Confirmation that the clean room structure (walls, floors and ceilings) has been installed according to design. This includes layout, room sizes and fittings.
HVAC system installation
Verification of the correct installation of the heating, ventilation and air conditioning (HVAC) system components, including air handling units (AHUs), ductwork and high efficiency particulate air (HEPA) filters. This includes AHU balancing.
Electrical system
Verification that all electrical systems and lighting are installed according to design and are functioning correctly. Back-up systems should be tested.
Plumbing and drainage
Verification of correct installation of any plumbing systems, including water supplies, drains and piping.
HEPA filter installation
Confirming that the HEPA or ultra-low particulate air (ULPA) filters are installed correctly in the clean room ceiling or HVAC units.
Control and monitoring system
Verification of the correct installation of facilities maintenance systems, environmental monitoring and control systems such as the building management system (BMS).
A BMS monitors, controls and optimises mechanical and electronic systems, such as AHU, fire dampers, environmental temperature management systems and alarms. It collects and records real-time data on how the building is performing.
Material and personnel flow
Ensuring that material and personnel flow through the clean room is according to design and adheres to the contamination control strategy (CCS).
For more information about the CCS refer to the article on understanding contamination control in pharmacy aseptic services (SPS page).
Documenting IQ
All qualification activities should be documented contemporaneously including the outcome (for example ‘pass’, pass with comment’, or ‘fail’) and related deviations.
All test reports, raw data, test instrument calibration certification, deviations and changes should be read, accepted and appended to the protocol as evidence.
Closing out IQ
Once IQ is complete all of the reports and results must be reviewed and approved by the user. The personnel who can approve IQ must be defined in the VMP.
Where a third-party validation specialist is used, the user is responsible for ensuring that they hold the proper accreditation, registrations and independence to perform an unbiased assessment. The user must still evaluate the reports and close out.
Closing out IQ will include review of:
- installation records and certificates
- as-built drawings and schematics
- equipment manuals
- calibration certificates where required for installed equipment, for example. pressure gauges
- test equipment calibration certificates
- changes, deviations and corrective actions
The IQ file containing all the approved documents should be retained in the unit for reference during all subsequent validation stages and throughout the operational life of the clean room suite.
All deviations should be resolved before final approval and proceeding to Operational Qualification (OQ). In certain circumstances it may be possible to give interim approval and proceed to OQ when outstanding deviations are low risk. This should be risk assessed and the criteria defined as part of the VMP.
Handover
At the end of IQ a formal handover stage transfers responsibility for the aseptic clean room from the contractor to the user’s qualification and operational team. This moment marks the transition from ‘build and install’ to ‘verify and qualify’.
There will typically be a formal handover meeting where documentation is reviewed, a facility walkaround and confirmation of completion of snag lists is undertaken, keys and access control rights are transferred, and a formal handover certificate or sign-off is documented.