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Potentially the most troublesome aspect of the EMA guideline [9] was the scope for inconsistent interpretation even in relation to the many apparently “well‐developed” concepts. Adding to this challenge of interpretation and consistent implementation are some further gaps that became evident the more one started to consider the kind of scenarios that would be encountered as the guideline was implemented. It is perhaps not surprising that regulators and industry alike struggled to fully understand how to interpret and apply it in its entirety.

To begin to resolve the difficulties described, further work and discussion took place after the final publication of the guidance in both regulatory circles (CHMP SWP and European Directorate for the Quality of Medicines) and in industry and industry trade associations (European Federation of Pharmaceutical Industry Associations – EFPIA) as all parties involved looked to examine these important topics, in depth, principally through a Question and Answer [10] process initiated by the EMA SWP.