White Paper: Pressure Builds On QPs

The move to backward integrate GMP into Active Pharmaceutical Ingredient (API) suppliers in Europe has not been as straightforward as was supposed. The implementation in October 2005 of the EU Directive (2004/27/EC) setting European-wide GMP standards has placed QPs under pressure. Their workload has increased as the new regulations require better quality and more detailed evidence from QPs that their API suppliers have met GMP status under ICH rules. This in turn has led to a dramatic rise in demand for API supplier audits. Consequently, API suppliers both in the EU and further afield are hosting an ever greater number of audit inspections from formulator QPs trying to keep ahead of the regulators. To make matters worse, the regulatory authorities are under resourced and struggling to ensure that standards are met. With a shortage of qualified audit inspectors available to provide the necessary validation of GMP, QPs of finished dose manufacturers are feeling the pinch when it comes to meeting supply demands.