Which of the following are included in the validation and qualification process for new equipment in a pharmaceutical facility? (Choose two) Response:

Question

Options

• ADesign Qualification (DQ)
• BOperational Qualification (OQ)
• CAesthetic Qualification (AQ)
• DSocial Media Qualification (SMQ)

• A
  82% (42)
• C
  14% (7)
• D
  4% (2)

Explanation

Design Qualification (DQ) and Operational Qualification (OQ) are two of the four established stages in pharmaceutical equipment validation, alongside Installation Qualification (IQ) and Performance Qualification (PQ). DQ verifies that the equipment design meets the intended purpose and regulatory requirements before it's built or purchased. OQ confirms that the equipment operates correctly within defined parameters once installed.

C (Aesthetic Qualification) and D (Social Media Qualification) are fabricated terms with no basis in pharmaceutical regulatory frameworks such as FDA 21 CFR or ICH Q7/Q8 guidelines - they exist only as distractors.

Memory tip: Use the acronym DIOPQ - "Did I Order Proper Qualification?" - to recall the four real stages in sequence: DQ → IQ → OQ → PQ. Any qualification term that doesn't fit this chain isn't real.

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