Step 1: What is validation?
In pharmaceutical manufacturing, validation is a key concept under GMP. It provides assurance that a process, equipment, or system actually does what it is supposed to do, consistently and reliably.
Step 2: The official definition.
Validation is defined as documented evidence that a process consistently produces expected results within predetermined specifications. The word documented is key. It means written proof, not just assumption.
Step 3: Types of validation.
Process validation, cleaning validation, analytical method validation, and computer system validation all share the same principle: documented, consistent, expected results.
Step 4: Eliminate wrong options.
Calibration of instruments is a separate activity. Verification of suppliers is vendor qualification. Training of personnel is an HR or GMP requirement, not the definition of validation itself.
Step 5: Confirm.
Validation is specifically defined as the documented evidence establishing that a process consistently produces a product meeting its predetermined specifications and quality attributes.
Answer: Option (3) — Documented evidence that a process consistently produces expected results