Quality Review

  • A Quality Review involves a periodic assessment of pharmaceutical products and processes to ensure consistency, quality, and compliance.

Annual Product Quality Review (APQR)

  • An APQR is conducted annually to:
  • Evaluate trends in manufacturing, stability, and quality control.
  • Identify any deviations or quality defects.
  • Suggest improvements in processes.
  • Ensure compliance with regulatory standards.
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Key Aspects

  • Review of batch records, test results, and stability studies.
  • Assessment of deviations, complaints, and recalls.
  • Audit findings and corrective actions taken.
  • Review of changes in raw materials, equipment, or SOPs.

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