What objectives are achieved through Performance Qualification (PQ) of equipment and utilities? (Choose two) Response:

Question

Options

• AConfirming consistent performance according to the intended use under real-world conditions
• BProving that equipment can operate with zero noise levels
• CDemonstrating compliance with regulatory and user requirements over time
• DEnsuring equipment can be operated via remote control

• A
  81% (44)
• B
  7% (4)
• D
  11% (6)

Explanation

Performance Qualification (PQ) is the final phase of the equipment qualification lifecycle (IQ → OQ → PQ), and its core purpose is proving that equipment performs reliably under actual operating conditions over time - which is exactly what A and C capture. Option A is correct because PQ tests the system under real-world, production-like conditions (not just controlled lab settings), confirming it consistently meets its intended use. Option C is correct because PQ generates documented evidence that the equipment satisfies both regulatory requirements (e.g., FDA, GMP) and the user requirements specification (URS) across repeated runs.

Option B is wrong because noise levels are irrelevant to qualification objectives - PQ is about functional performance, not acoustics. Option D is wrong because remote control capability is a design or operational feature, not a qualification objective; PQ doesn't test control mechanisms unless they're critical to performance.

Memory tip: Think of PQ as the "prove it in practice" step - Real conditions (A) + Regulatory proof over time (C). The distractors (noise, remote control) are obvious red herrings because they're physical or engineering features, not qualification goals.

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