Part 1 of Running a Marathon in Flip-Flops addressed the value of incorporating prerequisites into process validation using entering the Boston Marathon as an analogy.
For Part 2, the focus will shift to equipment qualification and the benefits of incorporating prerequisites into qualification
protocols. As was discussed in Part 1, entering the Boston Marathon involves a lot more than putting on a pair of running
shoes and showing up saying "I'm ready to run." There are predetermined qualifying standards that every applicant must meet
based on his or her age, sex, and disability status. In addition to having standards that must be met, the Boston Marathon
distinguishes itself by including a verification of an applicant's ability to meet their qualifying standard. For the marathon,
setting and verifying qualifying standards is important to evaluate the preparedness of the applicants for a safe and successful
race, which helps to ensure that the event will run smoothly.
The philosophy that is used to ensure a safe and smooth race also applies to a pharmaceutical or biopharmaceutical company
preparing for an equipment qualification. Qualifying standards, or prerequisites, can be used to evaluate the readiness of
a specific piece of equipment for qualification. Verifying prerequisites prior to the qualification ensures a safe and smooth
qualification process. For pharmaceutical or biopharmaceutical companies, this translates into less time and money spent on
avoidable delays. Because the requirements for a piece of equipment can vary widely from company to company, and even between
pieces of the same type of equipment, it is important to devise a universal set of prerequisites that will address all the
potential trouble areas. The following sections describe how prerequisites fit into an equipment qualification, discuss what
should be verified during prerequisite verifications in an equipment qualification, and outline a universal set of prerequisites
as well as address in detail the pertinent points for each category.
How prerequisites fit in an equipment qualification protocol
The process of setting up equipment in a pharmaceutical or biopharmaceutical facility includes ensuring that the equipment
will safely and consistently work as intended. To do this, it is necessary to verify that (1) the equipment is installed according
to the manufacturer's instructions, (2) the equipment is operated properly and consistently, and (3) the equipment performs
within the requirements determined by the facility. To cover all of the necessary criteria, equipment qualifications are typically
organized by separating the protocol into three sections, installation qualification (IQ), operational qualification (OQ),
and performance qualification (PQ).
Since the IQ, OQ, and PQ are performed separately, each should have its own set of prerequisite verifications. A prerequisite
in an equipment qualification is a documented verification that is intended to demonstrate that everything is in order prior
to initiating the execution of the qualification section. Because the equipment requirements at each of the qualification
stages are different, the prerequisite requirements at each of the qualification stages should be different as well. To explain
this concept, picture three different race applicants as the three sections of the qualification. If each applicant is in
a different age/sex category, then the qualifying standard that each would need to meet would vary depending upon which age/sex
category they belonged to. Because the race's start times are varied according to the age/sex category, the qualifying standards
for a 60-yearold woman do not require the same speed as the qualifying standard for a 20-year-old man. Likewise, it doesn't
make sense for a piece of equipment to be required to be at the same level of preparedness for the PQ as it is for the IQ.
What should be verified during prerequisite testing?
The general goal for prerequisite testing is to ensure that any items that commonly cause execution to be delayed or repeated
are in order prior to starting the qualification. Because of the variations between equipment and the differences between
how facilities operate, using the same prerequisite verifications may not always be the best approach. In order for prerequisites
to significantly help streamline the qualification process, they have to be tailored to fit the specifics of both the equipment
and the facility. Because it is easy to overlook potentially important prerequisites, it is often helpful to separate them
into categories and address them one at a time. With a good understanding of the categories, the process of tailoring the
verifications to suit a specific piece of equipment at a specific facility will be much smoother. Although it is nearly impossible
to cover all possible prerequisite verifications, some of the most common prerequisite categories are presented and explained
in the following paragraphs.