AZAVAI GxP Academy
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School of GMP and Pharmaceutical Quality

GMP fundamentals and quality system

Connect requirements to quality decisions and expected evidence.

Decision to master

Identify the applicable GMP requirement and choose a proportionate response within the quality system.

Learning objectives

  • Explain the quality intent associated with "GMP".
  • Identify the risks, responsibilities and evidence expected in a professional situation.
  • Formulate a proportionate, traceable and defensible decision.

Indicative programme

  1. GMP regulatory framework and pharmaceutical quality system
  2. Documentation, records and traceability
  3. Self-inspection, deviations and continuous improvement
  4. Case study: proportionate response to non-conformity

Prerequisites

  • Basic knowledge of pharmaceutical sciences or equivalent