For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing, and other services must comply with the products’ requirements throughout the chain of custody.
In this two part blog series I will convey the importance of qualifying the equipment and validating the processes through which your valuable biological material is managed.
It is commonly understood that freezers used for storing biological samples must be located, designed, constructed, adapted and maintained to suit the operation. Equipment qualification allows for testing and documentation of these expectations. The FDA requires that sufficient documentation be provided to show that the environment a product is exposed to will not affect the safety, quality, purity, identity, or strength of the product. Current good manufacturing practices (cGMP) regulations 21CFR parts 210, 211 and 820 detail this further. But compliance should not be the only reason why it is important to qualify freezers. The ability to test and document the evidence of equipment performance provides the operational confidence needed as the expected outcome is known.
Before we take a deeper dive it is important to understand the difference between validation and qualification, as these terms are used interchangeably and loosely at times.
Validation is best described as the process of “establishing documented evidence” which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use. Validation is carried out against a set of criteria that are defined in advance.
Qualification is described as the action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances. Qualification allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome.
Validation incorporates the concept of qualification!
Validation or qualification, the requirement for establishing documented evidence is imperative. The documented evidence is derived through testing. In our case, we achieve this through an equipment (freezer) qualification study. The qualification study details the process of testing, instrumentation used and recording the evidence against predetermined criteria, which shows that the freezer meets its intended quality attributes.
Stay tuned for Part Two of this blog series where we’ll expand on the four qualification stages and some common inquiries. In the meantime, download my eBook Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics to learn more about maintaining temperature throughout logistical activities.