It has been quite apparent to some of us in the pharmaceutical and medical-device industries that there appears to have been
a directed effort over the past number of years to eliminate the concept of and need for the installation qualification (IQ)
and the operational qualification (OQ). These two techniques were developed by the industry in answer to the validation requirement
mandated by the US Food and Drug Administration (1). The purpose of IQ and OQ was to verify that equipment and systems were
able to perform as intended.
Over the years, with the need to compress the timeline for products to be marketed and to decrease the cost associated with
the build-out of a new facility or process, IQ and OQ documents have been massaged and varied in complexity and content. The
IQ and OQ were also combined into a single-document format to save on paperwork as well as review and approval time. This
new combination became known as the IOQ.
Industry over the years has been pushing FDA for acceptance regarding a cutback on the apparent redundancy associated with
the validation process. It was argued that those validating were conducting tests that had already been performed during equipment
design and installation. Quality assurance (QA) was also to blame since they were reviewing aspects of the installation and
qualification that were not necessary. They were a bottleneck due to the time required for review, intrusive question and
answer sessions, minuscule document oversights, and unessential general approval.
Today many companies still follow the premise of IQ and OQ, but the introduction of other terms has downsized the importance
of these activities. In particular, the term commissioning was introduced into the vernacular of the industry. The purpose of commissioning was actually threefold:
- Commissioning was used to capture the pre-installation Factory Acceptance Test (FAT) and installation testing that was being
performed on the equipment and systems being installed.
- Commissioning was viewed as taking the place of the need to qualify those systems and equipment that were not deemed critical
but supportive in nature. Systems such as plant steam, vacuum, and heat transfer no longer required qualification. Commissioning
allowed them to stand on their own documentation merits and any associated verification would reside in the associated commissioning
documentation. New terms such as good engineering practices (GEP) would ensure that these documents were correct and usable.
- The third purpose of commissioning was to bridge the gap between design and installation, which was start-up. Using the information
afforded through a commissioning program would reduce the apparent redundant information gathering and testing that validation
was being accused of performing.
Over the same period of time, practitioners of commissioning were including more and more of the then-understood IQ and OQ
tests as part of the commissioning exercise. This practice has been altered to such an extent that the IQ and OQ have been
reduced to lists indicating that prior commissioning test had been properly completed. In essence, documents (IQ and OQ) that
were quite large in size in the past now are the smallest in volume. This occurred to such an extent that the IQ and OQ are
now understood by some in the industry as useless documents because they had been reduced to simple lists of prior test results.
These same criticisms did not mention other qualification test requirements such as the handshaking between equipment, the
testing of narrowed specificity of operational parameters associated with the particular process in mind, or the added computer-related
programming or interfacing that may be necessary. It has also become acceptable to have the pretreatment aspects of critical
utilities commissioned only and the final purification or critical process steps considered for qualification.
Role of QA
QA was always to be the independent reviewer and approver. QA personnel had no direct role in the design or manufacturing
processes. Their reporting structure also was to be independent and separate from engineering and manufacturing. They were
mandated with maintaining quality and an independent status through the regulations.
During the same timeframe, we have seen the erosion of QA in the qualification effort. Validation, which originally resided
in QA, was moved to either engineering or technical services. The reason for this was that only those disciplines could properly
test the equipment and systems because they had the necessary experience and education. Logically this may be justified, and
many companies today have already made the move. In some cases, even the performance qualification (PQ) and process validation
(PV) aspects of validation have also been removed from the QA umbrella.
With the original IQ and OQ, QA personnel reviewed and approved each document. They also reviewed the summary reports that
followed regarding these activities. With the onset of commissioning, the role of QA in the overall qualification scheme came
into question. Nowhere in industry guidelines was it stated that QA should review commissioning tests and commissioning-related
documentation. Again, the commissioned systems and equipment would stand on the merit of their respective commissioning documentation.
Some firms introduced the term commissioning closeout reports as an effort to include QA review and involvement. Other firms included QA as a team player in the overall process, but the
approval status was removed. QA was only to substantiate that critical systems were properly tested, qualified, and approved.
The concern with all of this shifting of responsibilities as well as approvals was that QA personnel were still the ones defending
the company activities to the FDA and other regulatory bodies. QA is typically the group defending the company's practices
and applications during an FDA inspection and not those who commissioned or reduced the involvement of QA in the overall facility-qualification
effort.
