| Author | Message | ||
     Fred Long |
The FDA has no specific guidance on NIR. There is general guidance on PAT (process analytical technology) There is a very good USP chapter on NIR. This covers both equipment qualification and method validation. It is # 1119. I would be happy to discuss this offline with you. Fred | ||
| Steve Blake |
Hi there. I'm working on implementing NIR for moisture analysis for a pharmaceutical and have come across a document by the EMEA, entitiled 'Note for Guidance on the Use of NIRS by the Pharmaceutical Industry and the Data Requirements for New Submissions and Variations' (phew!), dated February, 20 2003. It is very useful and describes what the EMEA considers is necessary for Method Development, Validation and Change Control for Qualitative and Quantitative NIR methods. Does anyone know if the FDA have produced any similar guidance? I've had a look at their website but without much success. Many thanks |