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.
Good information. Although the all the OOS investigation guidances provide the same requirements that is, first you need to ensure that there is no lab error, secondly what went wrong during manufacturing. Then there comes a question about batch disposition and preventive action to save other batches and it can also become a tool for continuous process improvement. The main point is, people need to report what actually happened, otherwise all the efforts in investigation go waste and you end up with completing the formalities for sack of compliance.
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