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Golden rules for Sponsor: Handling of Investigational Medicinal Products

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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.

Category:
Albert Einstein:
Success = Work + Play
PharmaGCP:
Successful business = Knowledge + Quality
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