In the pharmaceutical industry, term verification and validation are being often used, this article is furnished just for the understanding the difference between these two i.e. Verification V/s Validation.
How to Define Verification and Validation?
- Validation and verification these are two separate / individual processes, each of these have their own meaning. These terms are very closely related but different in terms of their objective and methods. In Pharmaceutical industry these are terms are vital for ensuring the Identity, Strength, Quality, safety and efficacy of pharmaceutical products i.e. Drug substances / Drug Products and medical devices. Although they are related, they have different objectives and are performed at different stages of the product lifecycle.
- Verification refers to the process of confirming that a system, process, or procedure meets the specified requirements i.e. intended use. It is essentially a check to ensure that a Process / product or system is designed according to the predetermined specifications. Verification activities involve conducting inspections, reviews, and tests to establish compliance with regulatory standards, industry guidelines, and internal procedures.
On the other hand, validation is the process of establishing documented evidence that a process / system consistently produce results that meet predetermined acceptance criteria i.e. fit for its intended purpose. Validation is being done specifically to demonstrate and to prove the consistency of the process. Process of Validation involves evaluation of the performance for reproducibility, reliability, and suitability of a process / product for its intended use and meeting the predefined quality standards.
Process Verification Vs Process Validation
Process verification is “confirmation by examination & provision of objective evidence that specified requirements have been fulfilled.” There is no specific definition of “process verification” in any guidance however general verification definition can be applied to processes as well as products or process.
FDA defines process validation as, establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
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At a glance, the definition of validation looks very similar to the definition for verification. However, process validation measures consistency of the process against established acceptance criteria, and verification is the process to verify the compliance of the test results against established specification.
Cleaning Verification Vs Cleaning Validation
Cleaning Verification is the term which is used for the activity performed to ensure that Cleaning Procedure is executed properly and equipment or facility is cleaned.
Cleaning Validation is the term used for the activity to prove that cleaning procedure is effective to clean the equipment’s / facility to remove all traces of contaminants from the surface or equipment.
Frequency of both the procedures is different like cleaning validation usually performed less frequently than the Cleaning verification activity. Cleaning verification procedures should be performed after each cleaning cycle to ensure that the cleaning process has been effective and performed appropriately. Cleaning validation should be performed at regular intervals to validate the effectiveness of cleaning processes and minimize the risk of contamination
System Verification Vs System Validation
If we talk about the system / Software these two terms are also have some difference like “mode of execution”; i.e. static and dynamic.
Verification is sort of static mode as in this process we verify the system / software with respect to out requirement with the review of documents, content of documents like codes and flow.
Verification of the system / software can be done by the process of Document Review / walkthrough / Inspection.
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On other hand Validation is sort of dynamic mode of execution, wherein we ensure that system / software is working as per the requirement with the execution of activity / process / codes in the system / software and check the obtained results.
Validation of the system / software can be done by the process of functionality check. Generally validation activity is being performed after execution of verification activity.
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In summary, Verification and validation are two distinct and critical words having some sort of similarity in their functionality in the pharmaceutical industry.
These terms are very critical to execute to ensure the product / process / system, for Identity, quality, safety and efficacy. They are often performed in accordance with regulatory guidelines, such as those provided by the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, to meet the stringent standards and regulations governing the industry.
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