QbD and RTRT - New Question and Answers published by EMA

In June 2013, the European Medicines Agency (EMA) added, among others, three new questions regarding cooperation between assessors and inspectors when processing Quality by Design (QbD) applications involving RTRT (Real Time Release Testing).

In cases of RTRT applications, the assessor should contact the relevant supervisory authority at the earliest opportunity to discuss the potential implications and clarify whether or not a GMP inspection is needed.

The level of cooperation depends on the complexity. A discussion between assessor and inspector is important to achieve a common understanding of the applicant's proposal and its potential impact on the marketing authorisation dossier and on-site situation. If a manufacturer uses complex technology (such as NIR or Raman spectroscopy) for RTRT for the first time, a product-specific inspection may be requested.

A further question addresses the data generated during parallel testing. Results of parallel testing should normally be included in the MA or variation submission, but can also be submitted later.

For more detailed information please also see the EMA "Quality of medicines questions and answers: Part 2"