Which of the following is a key element evaluated in the European Product Quality Review (PQR)? Response:

Question

Options

• AAnnual sales figures
• BCompliance with environmental standards
• CTrends in product quality data
• DCustomer feedback and satisfaction

• A
  8% (4)
• B
  4% (2)
• C
  71% (35)
• D
  16% (8)

Explanation

Trends in product quality data (C) is correct because the European Product Quality Review (PQR), mandated under EU GMP Annex 15 / Chapter 1, is a systematic annual review of manufacturing data - including batch analyses, deviations, out-of-specification results, and stability data - specifically to identify adverse trends and verify that manufacturing processes remain in a state of control.

• A (Annual sales figures) is wrong because PQR is a quality and regulatory tool, not a commercial one; revenue data belongs in business reporting, not GMP compliance reviews.
• B (Environmental standards compliance) is wrong because while environmental audits are important, they fall outside the scope of PQR, which focuses on product-specific manufacturing and quality data.
• D (Customer feedback and satisfaction) is wrong because PQR is internally driven by quality data from production and testing, not by customer satisfaction surveys (those belong in complaint handling or CAPA processes).

Memory tip: Think of PQR as a product's "health check-up" - just as a doctor tracks trends in your lab results over time, the PQR tracks trends in quality data to catch problems early, not to measure sales or customer opinions.

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