Test-instrument verification
Test-instrument verification is a simple way to eliminate costly delays and misunderstandings. The items that should be verified
in this section include any instrument or piece of equipment that is required during the execution of the protocol. Some examples
of instruments or equipment that are typically verified in a test-instrument verification include voltage meters, particle
counters, and scales. Because testing and sampling instruments and equipment are often used by many people and are often required
to be calibrated, typical items that are good to verify include the availability and/or location of the instrument and equipment
and the calibration status for the expected duration of the qualification execution. Just imagine the headache if, when it
came time to start a qualification, you realize that your scale is out of calibration or the particle counter you ordered
a month ago never arrived. Making arrangements for calibrations or tracking down an order often involves time-consuming activities
(i.e., getting approvals, contacting customer service representatives, and tedious paperwork). These tasks are time consuming
in general so why add to the burden by waiting to do them until it's too late to resolve the issue without holding up the
qualification? Performing prerequisites allows you to address the items before they start causing delays.
An incident during a qualification of an HPLC at a contract-testing laboratory shows how test instrument verification can
make a difference in a timeline. Arrangements were made for the manufacturer of the HPLC to come onsite to perform the qualification.
Due to the schedule limitations of the HPLC manufacturer, the first available time the qualification could be completed was
two weeks away. When the technician arrived, he quickly discovered that all of the scales in the laboratory that were suitable
for his requirements were due for calibration. The calibrations were scheduled and performed but the delay left the technician
with insufficient time to complete the qualification before his next assignment. A second visit had to be scheduled with the
technician for the qualification to be completed. The hassle of additional scheduling and the delays incurred could have been
eliminated had the contract-testing laboratory performed a test-instrument verification prior to the arrival of the technician.
Equipment status verification
The purpose of equipment-status verification is to ensure that the equipment being qualified is installed and ready for qualification.
Like with procedure verification, different requirements, or specifications, are typically desired for different sections
of the qualification. For example, while it might be necessary for the equipment to be set up, calibrated and ready to run
during a PQ, for the IQ, it's only necessary for the equipment to be installed. Another possible inclusion in equipment status
verification is the availability of the equipment for use. Unlike process validation, which cannot be started until a process
has been developed, equipment qualification protocols are sometimes written before the equipment is even received. As a result,
a protocol can be ready for execution long before the equipment has arrived and been installed.
Recently, the qualification of a building management system at a biopharmaceutical facility was scheduled to begin and consultants
were hired to execute the protocol. When the consultants arrived at the facility to begin the qualification, they found out
that an ancillary electrical panel had not been installed because it was on back order. If the equipment status had been verified
prior to the qualification, the cost and time of the additional onsite visit by the consultants in order to reassemble the
team could have been avoided.
Additional benefits to prerequisites
Now that some of the ways prerequisites can be beneficial during the execution of an equipment qualification have been identified,
it should be mentioned that prerequisites offer benefits to other areas as well. Documenting the prerequisites creates a system
that proactively assists in tracking future problem areas rather than tracking only problems that have already occurred. When
combined with the existing methods of identifying trouble areas of the quality system, prerequisites provide a little extra
help in meeting the overall goal of preventing problems rather than just reacting to them.
Last, but certainly not least, in the list of benefits to adding prerequisites to a validation/qualification program, is how
they will help before an audit. By performing these simultaneous "spot checks" or verifications of the quality system, it
will be possible to generate trends of where problems tend to arise in the quality system. The additional method of locating
these holes and inconsistencies will help a company know where they need to focus their efforts prior to an audit instead
of after an auditor has found the issues.
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