Based on a survey, the EFPIA has published a highly interesting position paper. It describes the problem represented by the continually increasing number of international authority inspections of globally acting pharmaceutical enterprises. Up till now, mainly the contract and active API manufacturers felt patronised by the rising number of customer audits, which has been increasing especially in the last few years. But not only auditors from other firms, inspectors from authorities all over the world, too, contribute more and more to the constant coming and going. Here, the pharmaceutical industry sees an urgent need for further harmonisation.
Of course, the pharmaceutical industry acknowledges the right to and the benefit of supervision by the competent authorities. Still, the increasing number of foreign inspections requires a lot of resources on the part of the industry, but also on the part of the authorities. According to the conducted survey, the number of inspections by foreign authorities has doubled since 2003. With an average of 130 man days per inspection on the part of the industry, thus an annualised sum of 121,047 man days had to be raised in 2008 alone.
In its position paper, EFPIA points out several possibilities for improving the situation:
"Improved use of resources focused on risk control
Refocus industry and regulatory resources from duplicated GMP inspection activities to preventive measures, such as product quality improvement and supply chain risk management (e.g. anti-counterfeiting, adulteration, wholesalers, export activities, harmonised interpretation of GMPs, faster approval of changes)"
"Inspection programmes aligned with higher risk entities
Apply risk-based approaches to the scheduling and conducting of GMP inspections."
"Intelligence and communication between regulatory agencies
Use appropriate tools and methodologies to evaluate and communicate foreign GMP inspection activities (including planning), intelligence and performance throughout the pharmaceutical industry sector. Develop work processes that allow sharing of GMP inspectional performance measures with other regulators globally without legal or regulatory restrictions."
"Work towards a global regulatory inspection framework with the aim of achieving a reduction in:
- the frequency and/or duration of GMP inspections, both on-site and paper-based,
- the amount of documents to be submitted prior to or instead of a GMP inspection through:
- mutual acceptance of GMP inspection results (e.g. amongst inspectorates which are PIC/S members and the pilot project on international GMP inspections FDA/EMEA/TGA),
- expanding the scope of existing MRAs to cover a wider range of products including e.g. sterile and API (e.g. MRA EU-Japan, EU-Switzerland),
- establishing formal collaborations where there is no MRA between countries e.g. MoU
- utilising existing GMP certification approaches, e.g. in analogy to the WHO Certificate of Pharmaceutical Product form."
Source: EFPIA Position Paper
In the ECA Education Course Efficient Supplier Qualification (Prague, Czech Republic, 18-19 March 2010) you will learn how to use a risk based approach while planning your audits. You will get to know possibilities and tools to increase efficiency and decrease costs in your company.
On behalf of the European Compliance Academy (ECA)