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Quality Control and Quality Assurance, Code 115

Aim of the Course

The aim of this course is to provide the students with information on Q.A. and Q.C. submitting analytical procedures, validation data, and samples to support the documentation of identity, quality and purity of drug substance and drug products.

Course Contents

  • Good Analytical Practice and Sampling:
  • 1.Introduction
  • 2.Sampling of pharmaceuticals and related materials.
  • 3.Type of sampling tools
  • 4.Sampling plans
  • Documentation:
  • Validation of analytical methods:
  • 1.Compendial testing
  • 2.Validation of analytical methods
  • 3.Data elements required for assay validation
  • Drug stability, stability studies and stability indicating methods
  • 1.Drug stability
  • 2.Stability testing
  • 3.Forced degradation studies
  • 4.Stability indicating methods


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