Guidance

Out-of-specification investigations

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 28 August 2013
• Last updated: 26 February 2018 — See all updates

Documents

Out of specification guidance

MS PowerPoint Presentation, 882 KB

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Details

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. 26 February 2018

   Check of information and is still accurate.

2. 28 August 2013

   First published.