Qualification & Validation
Qualification is a process of assurance that the specific system, premises or equipment are able to achieve the predetermined acceptance criteria to confirm the attributes what it purports to do.
Validation is establishing a documented evidence to provide a high degree of assurance that a specific system, process or facility will consistently produce a product meeting its predetermined specifications and quality attributes.
Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use.
Validation is documenting that the way equipment, facility or system used will result in product meeting its predetermined specifications and quality attributes.
Things are qualified: equipments, systems etc. Process/Procedures (the way we use things) are validated.
Before you do validation on a process, you have to be sure that the equipment has passed qualification.
Qualification
Qualification of analytical instrumentation is essential for accurate and precise measurement of analytical data. If the instrumentation is not qualified, ensuring that the results indicated are trustworthy, all other work based upon the use of that instrumentation is suspect. For the purposes of this article, the assumption will be made that the foundation of validation and verification work to follow is based solidly upon well-qualified instrumentation.
Validation
Numerous documents provide definitions of validation. A dictionary definition of validation includes “…the process of determining the degree of validity of a measuring device,” and for validate: “to make legally valid,” with synonyms “verify, substantiate.” Clearly, the synonyms do not distinguish between validation and verification, so let us now turn to definitions provided by other sources. USP chapter ‹1225› “Validation of Compendial Procedures” provides the following:
“Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.”
From the ICH document Validation of Analytical Procedures: Text and Methodology:
However, it is important to remember that the main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose (4).
Qualification & Validation
Qualification and Validation are integral steps in building quality into any facility. Spectrum with an experience of over two decades provides an efficient and effective documentation system that meets the requirements of International Regulatory authorities.
Our team of experts can manage development and implementation of entire Validation program for its Customers.
