Question

Establishment of documented evidence providing high degree of assurance that a planned process will consistently perform according to the specified outcome is called as:

• A. Validation
• B. Quality assurance
• C. Accuracy
• D. Calibration

Hint:

Validation = Documented Proof + Consistency.

Answer 1

The Correct Option is A

Step 1: Concept
This definition refers to the systematic approach used in pharmaceutical manufacturing to prove that processes work as intended.

Step 2: Meaning
It involves collecting and evaluating data, from the process design stage through commercial production, which establishes scientific evidence.

Step 3: Analysis
While Quality Assurance is the broad umbrella of systems, and Calibration refers to equipment accuracy, "Validation" specifically refers to the "documented evidence" of "consistent performance".

Step 4: Conclusion
The provided definition matches the international regulatory definition of Validation.

Final Answer: (A)