Which of the following is an example of a document that would be reviewed to confirm compliance with GMP requirements? Response:

Question

Options

• AAn employee's personal diary.
• BA list of potential company names for a rebranding initiative.
• CThe company's annual holiday schedule.
• DA batch manufacturing record.

• A
  8% (4)
• B
  4% (2)
• C
  14% (7)
• D
  75% (38)

Explanation

A batch manufacturing record (BMR) is the primary document audited during GMP inspections because it captures every step of a product's production - materials used, quantities, equipment, in-process checks, and operator sign-offs - providing a complete, traceable account that regulators use to verify a batch was made exactly as specified in approved procedures.

Options A, B, and C are all unrelated to manufacturing operations: a personal diary is a private document with no regulatory relevance; a rebranding name list is a marketing/business activity; and a holiday schedule is an HR administrative document - none of these touch the manufacturing process or quality system that GMP governs.

Memory tip: Think of GMP as governing everything that touches the product - if a document doesn't directly record, control, or verify how a product is made, tested, or handled, it falls outside GMP scope. BMRs are the paper trail that proves every batch was built to spec.

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