A Critical Discussion of EMA's 2014 NIR Guideline and Addendum: The foreseen impact on NIRS use by the Pharmaceutical Industry

EMA’s NIR Guidelines span more than 10 years: 2003 Guideline, 2009 Note, 2012 Draft Guideline, 2014 Guideline and Addendum. After a long period of consultation and feedback from industry, the long awaited final version of the 2012 Draft was known in June 2014. EMA’s finalized document (dated January 2014 and internally approved by March 2014) was stamped for adoption from September 2014 onwards. However, in June 2014 an Addendum to the 2009 Note was also released that in practice should be considered together with the 2014 Guideline.

Many points for improvement were sent in due time to EMA by different stakeholders and analyzed almost over a two-year long period. Several made its way into the Guideline and helped improve this very important document. Many others, however, did not. This talk is about what still needs to be improved and why, both in the Guideline and its Addendum, to avoid the foreseeable impact on the role of NIR as a ‘de facto’ PAT tool and as QbD enabler in pharmaceutical drug substance and drug product manufacturing. Aspects like scope definition, procedure development and change management over lifecycle will be discussed.