Quality Management

The HPRA is committed to the implementation and maintenance of a documented quality management system which is continually improved. The system is based on the requirements of the legislation, the regulatory system and ISO 9001; it also takes into account guidelines, standards and best practices from Irish and international organisations. The HPRA has adopted a quality policy:

To help us to achieve the goals set out in our mission statement, we will ensure that quality is central to all aspects of our work by:

  • Establishing, implementing and maintaining a documented, effective quality management system in line with best international practice
  • Incorporating HPRA corporate quality objectives, essential to the implementation of strategy and based upon our customers’ needs and expectations, into functional targets and work plans
  • Monitoring our performance against these quality objectives, and reviewing and revising them as necessary to ensure that we achieve our aims for continuous improvement
  • Ensuring that a trained and experienced team of HPRA personnel, committed to achieving our quality objectives, is available and that these staff members are provided with appropriate resources, in terms of infrastructure, to achieve these objectives
  • Complying with the requirements of all relevant financial reporting standards, legislation, and Board and government policies
  • Aiming to maximise the reuse and recycling of materials and minimise the production of waste material

The quality system is implemented and operated by all HPRA staff, with a dedicated section within the Quality, Scientific Affairs and Communications Department, to oversee and co-ordinate the work. Internal audits help to provide quality assurance to management that the system is operating effectively, and contributes to the improvement of systems and processes. According to Article 101(2) of Directive 2001/83/EU, each Member State must submit a summary of the results of internal audits of its pharmacovigilance system to the European Commission. The first report was submitted in September 2013 and is published below as a transparency initiative. 

Summary of pharmacovigilance system audit report results 2013