News about GMP/cGMP


MHRA: Out of Specification Guidance

The MHRA has updated its interesting guidance on how to handle OOS results. The issue faced when dealing with “Out of Specification” results is always a challenge. Many customer requests we receive address this issue.

Lesley Graham, MHRA, who wrote a blog post on the guidance states “When a laboratory embarks on an investigation their biggest challenge is to move from a position of “I think this is the cause” to “I know this is the cause”. It was this challenge that gave rise to the idea for the presentations delivered in the GMP stream at the recent MHRA Labs Symposium.” The guidance – which is in form of a PowerPoint presentation offers a stepwise approach on what should be considered at each stage of an investigation. The guidance has recently been reviewed and updated and is well worth reading.
Click here for direct access to the comprehensive OOS-guidance.


MHRA: Blog – MHRA Inspectorate