The European Medicines Agency (EMA) issued a report to highlight the agency's work, including inspections of good manufacturing practices (GMPs), for the first half of 2015. The report, issued this month, shows a nearly 50% increase in GMP inspections thus far in 2015. So what is behind the jump in GMP inspections? DCAT Value Chain Insights (VCI) takes an inside look.
For the full year of 2015, the EMA expects to conduct 425 GMP inspections, a 9% increase in its original estimate for 2015. The agency also provided updates to its efforts to increase risk-based inspections, improve overall pharmaceutical supply chain integrity, and mitigate drug shortages.
Looking at the report
The EMA report showed that in the first half of 2015, the agency conducted 350 GMP inspections, which is up from the number of inspections year-over-year (i.e., first half) in 2014, 2013, and 2012. In the first half of 2014, the EMA conducted 235 GMP inspections, 259 in the first half of 2013, and 196 in 2012. For the full-year of 2015, the EMA expects that it will conduct 425 GMP inspections, which is up from its initial estimate of 390 inspections.
In highlighting its progress in GMP inspection in its mid-year report, the EMA noted the launch implementation of its risk-based inspection program for third country manufacturing plants of centrally authorized products, which focus European Union (EU) inspectional resources to sites of highest risk. The agency noted that its risk-based approach to inspections has been fully implemented since the third quarter 2014 with the inspections programs for each year prepared considering the risk-based aspects.
In its report, the EMA noted a key activity of facilitating cooperation among regulatory agencies as it relates to inspections. It said its plans to develop a plan for further cooperating with EU member states in coordinating third-country inspections in 2015 and to implement that plan in 2016. To that end, the EMA noted in its report that the re-inspection program is planned to be re-framed to encompass inspection plans from the European Directorate for the Quality of Medicines, which is responsible for the European Pharmacopoeia and the European biological standardization program, and from the third-country inspection planning module from national competent authorities.
In its report, the EMA also noted that it seeking to establish a mutual reliance framework with the US Food and Drug Administration (FDA) based on the existing mutual recognition agreements to increase the scope of EU international inspections activities. The EMA said that the US FDA reaffirmed its support to support the initiative in the first half of 2015. EMA’s response to FDA queries was finalized in the first quarter while the EU assessment of the FDA system continues. The EMA also noted that it is seeking to establish a mutual reliance network with international partners performing inspections of active pharmaceutical ingredients and human and veterinary products.
As part of its goal of maintaining quality and continuity of medicines’ drug supply chain and to prevent circulation of falsified medicines, the EMA has established a goal to develop procedures to link the parallel distribution process with GMP procedures and allow use of parallel distribution information in the detection of falsified medicines in the supply chain. To that end, the EMA said in its report that internal discussions took place during the first half of 2015 to discuss the linkage between parallel distribution and market surveillance activities.
An additional activity noted by the EMA in its goal of supply-chain integrity and security is to conduct lessons learned from problems relating to stolen medicines in 2014 to further reflect how networks can address similar future threats to the supply chain. To that end, the EMA noted that the so-called “Operation Volcano” report on stolen medicines was adopted by the heads of medicines agencies in May 2015.
Another goal cited by the EMA in its report is to improve mitigation of shortages of human medicines caused by GMP non-compliance and quality defects. EMA said its activities to address that were to first identify process improvements on the handling of quality defects and non-compliance issues in 2015 and then implement them in 2016. To that end, the EMA said the recording steps and tracking tool for quality defects were redesigned in the second quarter of 2015. Updating the report form and related standard operating procedures will start toward the end of the year.
A final key activity noted by the EMA in its report was research on the root causes of quality defects and GMP non-compliance leading to shortages of human medicinal products. The agency said that a spreadsheet template was redesigned in the second quarter to facilitate reporting and analysis of root causes of quality defects. Work on a catalog of root causes also started in the second quarter of 2015.