Golden rules for Sponsor: <em>Handling of Investigational Medicinal Products</em>


Golden rules contain GCP requirements, best practice and practical examples within:

  • Forecast and preparation
  • Input to protocol
  • Outsourcing
  • Labelling
  • Packaging
  • Release
  • Instruction to investigators and site staff
  • Distribution
  • Return and destruction
  • Handling of temperature deviations


Include examples of inspection findings when the rules were not followed.

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Success = Work + Play
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