What is 'validate' vs 'verify' in GMP context?

• A. Validate means checking documents; verify means checking equipment.
• B. Validate proves that a process consistently produces safe product; verify confirms ongoing performance.
• C. Validate is about testing product taste; verify is about packaging integrity.
• D. Validate is the same as verify.

Answer: (B)

In GMP, validation is about proving that a process will reliably produce a safe product under real operating conditions. It involves gathering evidence that, when the process is run as intended, it consistently meets predefined safety and quality criteria. This often covers the full development and qualification of a method, including the design, installation, and performance qualification—showing that the process is capable.

Verification, on the other hand, is about confirming that the process continues to perform as intended during routine operation. It’s ongoing monitoring and checks—such as calibration of instruments, in-process controls, batch record reviews, and trend analyses—that ensure the validated process remains in control over time.

So the best choice reflects this distinction: validation proves a process can consistently produce a safe product, while verification confirms that it continues to perform correctly on an ongoing basis.