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What is the simple meaning of process validation?

Answer and explanation

Correct answer: It is documented proof that a process consistently produces results of the intended quality.

Process validation provides documented evidence that, under defined conditions, a process can repeatedly produce a product or result of the intended quality. Therefore, option A is correct. Testing only the final product (option B) may be part of quality control, but it does not establish the consistent reliability of the whole process. Exam tip: remember validation as “documented evidence of consistent performance.”

Related tags

Process ValidationBioprocess EngineeringQuality AssuranceQuality ControlBiotechnology ManufacturingPrinciples Of BiotechnologyBiotechnologyClass 11 Mcq

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