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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For more relevant # What is Validation study- Basic overview |
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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For more relevant information, visit # Computer system validation (CSV) in Pharmaceutical Industry!! Introduction |
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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