- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Good practice, inspections and enforcement
- First published:
- 28 August 2013
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
PDF, 283KB, 39 pages
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This Medicines and Healthcare products Regulatory Agency guidance for those carrying out of specification investigations covers:
- laboratory analysis
- phase Ia investigations
- phase IB investigations
- phase II investigations
- phase III investigations
- batch disposition
Published: 28 August 2013