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

Procedure verification

Procedure verification includes any procedure that is required for operation or maintenance of the equipment as well as any sampling or testing procedures required to obtain and analyze the protocol samples. For each of these procedures, the status of the procedure, the title and the document number are typical items that are verified. The specifications vary depending on the section of the protocol the verification is being written for (i.e., IQ, OQ, or PQ). For example, during the IQ, it might be acceptable for the procedures to be in draft form, but by the time the PQ section is going to be executed, it is necessary for the procedures to be approved documents.

An example of how performing a procedure verification could make a costly difference to a company is evident in the events during an HVAC qualification at a sterile drug facility. Additional personnel were brought in to perform the time-consuming task of collecting microbial samples for the qualification and when the samples arrived at the laboratory, they realized that the testing procedure for the samples was still in development. None of the samples taken were usable, and the entire collection process had to be repeated once the testing procedure was approved. The expense of the wasted man-hours and supplies and the delay to the qualification could have easily been avoided by implementing a procedure-verification prerequisite.

Training verification

The importance of verifying the training of operators and test personnel is a universal prerequisite throughout the various types of validations and qualifications. For equipment qualification, verifying training is like making sure a runner has the experience they need to successfully finish the marathon. With equipment, it's important to verify that the personnel who will be operating the equipment, in addition to the personnel executing the protocol, have the training required to successfully perform the necessary tasks according to the currently acceptable method.

Picture an operator executing a performance qualification of an autoclave if that person doesn't know how to control the equipment—the importance of verifying operator training becomes clear. What may not seem as clear is why it is important to verify the training of the qualification test personnel. A biopharmaceutical manufacturer learned the importance of test personnel training during the qualification of a freezer. The freezer qualification included a 72-hour temperature mapping, which required monitoring and recording the temperature in different quadrants of the freezer at specified time intervals for a 72-hour period. During an audit, it was discovered that the data was not collected for the full 72 hours. An investigation was conducted and the error was determined to be due to the fact that the test personnel who set up the mapping were trained on an earlier revision of the protocol and didn't realize the time interval had been changed. When compared to the time spent on tasks that have to be repeated due to avoidable mistakes, spending the time to perform prerequisite verifications becomes time well spent.

Utilities verification

Though not actually a part of the equipment, utilities are essential to their operation since the equipment cannot run without them (e.g., electricity, compressed air, gas, water, etc.). Utilities that should be verified include any utility that is required to execute the protocol and has the possibility of not being available or not being available at the required level.

An example of the benefit of performing utility verifications was seen during the qualification of a packaging line of a drug manufacturer. For the packaging line to operate as required, the air compressor needed to maintain a specific pressure. During one of the qualification runs, failures were observed in both the desiccant and the cotton insertion stations. Investigation led to the discovery that the capacity of the compressed air system was not adequate to operate all of the stations of the line simultaneously. Although the problem was identified, the time needed to correct the problem and re-run the test was costly and could have been avoided had the capacity of the compressed air system been verified using the utility qualification of the compressed air system prior to starting the testing.


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