M.Pharm Semester 1 · Pharmaceutical Quality Assurance: Quality Management System notes. Quality Management System studies how responsibilities, records and processes work together to support pharmaceutical quality. A system map helps connect apparently separate procedures.

What to revise

  • Framework: distinguish policy, procedure and evidence of implementation.
  • Control: connect stability and statistical process monitoring with decisions.
  • Review: organise inspections, responsibilities and improvement processes.

A quick self-check

Map a fictional quality issue through observation, investigation and follow-up. Identify the record linking each stage and the person responsible for review.

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