Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment Qualification - Pharmaceutical Technology

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Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment Qualification
Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.


Pharmaceutical Technology
Volume 9, Issue 32

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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