Quality

Quality

  • Review and approval of local artworks for printed packaging components
  • Handling local product complaints and ensuring appropriate treatment of quality issue which could have an impact on Public Health
  • Handling of batch recalls (if applicable)
  • Review of results of Annual Product Quality Review, in close collaboration with the MAH/ATU holder, and assessment made as to whether CAPA or any revalidation should be undertaken
  • Follow-up of quality of partners (manufacturers, distributors, …): audits, annual review of contract
  • Monitoring of stock with minimization measures for preventing drug shortage (for essential drugs)
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