NIPTE on GMP inspections: The benefits & challenges of mutual recognition

Ajaz Hussain is the president of the National Institute for Pharmaceutical Technology and Education (NIPTE), principal of consulting firm Insight Advice & Solutions, and former deputy director the of US Food and Drug Administration’s (FDA) Office for Pharmaceutical Studies.

Hussain (AH) is the regulatory keynote speaker at CPhI Worldwide’s Pre-connect Congress held today in Frankfurt, Germany, but in-PharmaTechnologist (IPT) spoke with him ahead of his keynote to discuss the future of manufacturing facility inspections. 

IPT: ​What is the current state of manufacturing inspection regulations in the US and Europe?​

AH: A long-standing agreement, signed in 1998, between the US and the EU – the Agreement on Mutual Recognition (MRA) – to recognize each other’s GMP (good manufacturing practice) inspections was never fully implemented until the 2017 amended MRA, which moves this effort forward, finally. Now, by utilizing each other’s inspection reports, a lot of duplication can be eliminated and resources reallocated to “high risk” facilities.

IPT: How do you predict this will change in the future?​

AH: The 2017 MRA implementation is a very promising step forward. Beyond resource saving and reallocation, it will contribute to opportunities to reduce variability in interpretation of diverse observational finding and facility a move towards more objective risk-based approaches. 

IPT: How will drug makers benefit from regulatory uniformity in the GMP inspection process?​

AH: In the short run, reducing the number of inspections should save time and make work more predictable. In the long run, reduced heterogeneity can pay a dividend. However, for this to be fully realized, certain hurdles need to be considered.

IPT: What hurdles need to be overcome?​

AH: Companies with facilities in both the US and EU regions should have an opportunity to gauge how the FDA will use (e.g., for enforcement actions) EU observations, and vice versa.

Reducing heterogeneity of facility risk classification and pharmaceutical quality system assessment would be another area that industry should seek to achieve.  

Despite the International Conference on Harmonisation’s (ICH) efforts, significant differences remain between the US and EU in how product specifications are set and how the compendia are utilized in the two regions.  This can impact the rate of out-of-specification (OOS) investigations, and invalidated OOS rate (these are subject to GMP inspections).  It will be useful to seek more harmonized approaches for all aspect so OOS.

IPT: How do you envisage ‘Brexit’ will affect regulatory relations?​

AH: There is concern from a logistics and resource perspective, but I don’t expect stance and approach – at a professional level – to change.