OOS Results - Very helpful Q&As published on the MHRA Website

The FDA Guidance on OOS Results from 2006 is well known among the pharmaceutical industry. Guidance from the MHRA on how to handle out-of-specification results during laboratory analysis is - on the contrary - pretty unknown although an own webpage on the MHRA website is dedicated to the OOS topic.

This webpage lists 20 questions. Here are some of the topics dealt with:

  • When is it acceptable to declare test results invalid?
  • How many repeat tests should be conducted?
  • Can OOS results and pass results be combined? 
  • How the certifying QP should handle unclear results
  • Averaging of separate test results
  • Retesting
  • Re-sampling
  • Outlier tests

To read all the 20 questions and answers please see "Out of specification (OOS) FAQs".

On the MHRA website, you can find a complete presentation on Out Of Specification Investigations. The presentation ends with the following statement: "Microbiological expectations will be provided at a later date."

At ECA's OOS Forum on 19/20 June 2012 in Prague, Di Morris, GMP Inspector for Medicines and Healthcare products, MHRA, UK, will give a presentation about "OOS in Microbiology". For the first time ever, she will present the requirements of a European authority regarding the GMP-compliant handling of OOS results in the microbiological laboratory.

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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