FDAs guidance on Out-of-specifications (OOS) is well known. Now 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.
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."
These FAQs and interactive presentation provide guidance on what to do if an out of specification result is identified during laboratory analysis.
Click here to read and download the guidance.
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."
These FAQs and interactive presentation provide guidance on what to do if an out of specification result is identified during laboratory analysis.
Click here to read and download the guidance.
