Understanding operational qualification
Operational qualification (OQ) is the documented process of confirming that the installed equipment, facility or systems:
- consistently operate in accordance with design specifications
- perform as intended throughout the anticipated operating ranges and conditions
Defining the OQ protocol
The OQ protocol is usually written by the contractor or by a third-part validation specialist, but the user must approve it and be assured that the qualification meets their requirements as specified in the URS.
The OQ 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).
It will include details of:
- responsibilities and persons performing OQ
- introduction and scope
- how data is collected and documented
- acceptance criteria
- how non-conformances are managed
- responsibilities for approval
The OQ may take the form of a workbook. This defines the scope of the tests and the acceptance criteria It may include sampling plans, the details of testing, test equipment, space for the results, and any deviations and changes.
Pre-requisites before starting OQ
In addition to the OQ protocol, the following must all be in place before starting OQ.
OQ team
Personnel involved in the execution of OQ must be named in the protocol.
The team for OQ may include:
- Production manager
- Accountable Person
- Head of Quality Assurance
- Chief Pharmacist
- Production team leaders / operators
- Estates
- third party validation specialist
Refer to the article about assembling a clean room design and build team (SPS page).
Prerequisites
Define and document the perquisites within the protocol in advance.
Installation qualification (IQ)
Installation qualification must be completed.
Facility handover
Facility and HVAC have been handed over in normal operating conditions, with any outstanding snagging risk assessed and accepted, with remedial actions performed or planned.
No work or actions that would impact OQ are outstanding.
Cleaning
The unit has been cleaned as specified within the URS. This is typically referred to as a builders clean. It includes confirmation that no tools, excess materials or debris remain, to ensure the suite is safe for qualification personnel.
Standard operating procedures
Operational and support Standard Operating Procedures (SOPs) are working drafts as a minimum. Working drafts are provisionally approved SOPs used for testing processes during qualification.
Undertaking OQ
OQ 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.
OQ should be assessed to include worst-case scenarios, for example, testing should include recovery from a failure such as power interruption to equipment or plant.
Scope of OQ
OQ follows IQ and may repeat some elements. The key distinction is that IQ confirms correct installation whereas OQ confirms the system operates as intended across the defined ranges. OQ protocols may briefly recheck IQ elements including, but not limited to, the following.
HVAC system
Verification of the correct operation of the heating, ventilation and air conditioning (HVAC) system components, including air handling units (AHUs), ductwork and high efficiency particulate air (HEPA) filters.
This will include; HVAC system recovery and alarm check, room pressures, pressure differentials (gauges and micromanometer) and noise levels.
Electrical system
Verification that all electrical systems are functioning according to design and are functioning correctly. This includes lighting, wiring for IT access and electrical interlocking mechanisms functionality Back-up systems should be tested.
Plumbing and drainage
Verification of correct functionality of any plumbing systems, including water supplies, drains and piping.
HEPA filter
Confirming that the HEPA or ultra-low particulate air (ULPA) filters are operating correctly in the clean room ceiling or HVAC units, including filter integrity tests.
Control and monitoring system
Confirming that the HEPA or ultra-low particulate air (ULPA) filters are operating correctly in the clean room ceiling or HVAC units, including filter integrity tests.
Full system functionality
Verification that the full system delivers the specified functionality including:
- air change rates
- air flow pattern visualisation
- clean up rates (recovery test)
- particle counts
- temperature and humidity
- critical alarms and sensor functionality
Documenting OQ
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 OQ
Once OQ is complete all the reports and results must be reviewed and approved by the end user. Where a third-party validation specialist is used, the user is responsible for ensuring the third-party validator holds the proper accreditation, registrations and independence to perform an unbiased assessment. The user must still evaluate the reports and close out.
The personnel who can approve OQ must be defined in the VMP.
Closing out OQ will include review of:
- test results
- equipment manuals
- calibration certificates where required for installed equipment, for example pressure gauges
- test equipment calibration certificates
- changes, deviations and corrective actions
The OQ 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 Performance Qualification. In certain circumstances it may be possible to give interim approval and proceed to Performance Qualification when outstanding deviations are low risk. This should be risk assessed and the criteria defined as part of the VMP.