Out-of-specification investigations

Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.


Out of specification guidance

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This Medicines and Healthcare products Regulatory Agency guidance for those carrying out of specification investigations covers:

  • Laboratory analysis
  • Results
  • Phase Ia investigations
  • Phase Ib investigations
  • Phase II investigations
  • Phase III investigations
  • Batch disposition
Published 28 August 2013
Last updated 26 February 2018 + show all updates
  1. Check of information and is still accurate.
  2. First published.