Quality policy
The main goal of the National Institute of Pharmacy is to perform its responsibilities given by the Foundation Documents and by other laws, for the sake of patients and for prevention according to the regulations, continuously improving its activity. On the other hand in cooperation with our partners (other authorities, EMEA) we take special care on the follow up the satisfaction and wishes of our customers (applicants, patients, physicians and pharmacists and their professional and representation of interests organizations) and fulfill them. Our expectation toward our contracted suppliers is to contribute to our goals by the quality of their services.
Following the accession to the European Union we do consider as priority to meet the international expectations by our quality management system. We are seeking to introduce legally harmonized procedures on three professional priority fields and to implement and follow up them. The priority fields are The Good Manufacturing Practice, the Dossier assessment and the Pharmacovigilance. Our long term goal is to introduce and implement the legal harmonized procedures on all the professional fields.
The Integrated Quality Management System (IQMS) is operated on the basis of the related EMEA (European Medicine Evaluation Agency) Guides and according to the ISO 9000:2000 (9001 and 9004) standards in non certified form. Our Laboratory meets requirements of the ISO/IEC 17025 standard and the internal audit system uses the elements of the ISO 19011:2002 standard. On the proposal given by the Presidential Conference of the European Council (Lisbon, 23-24, March 2000), EMEA decided the use of benchmarking for the network of the NCAs, as the tool of the establishment and assessment of consistent quality management systems. The experiences gained from the use of the internal audits and the management reviews system are used as tools for the continuous correction and improvement. The guarantee for continuous improvement is to ensure the continuous professional upgrading of our colleagues by supporting their new professional education, language courses and participating professional/scientific meetings.
The management is comitted for keeping and full implementation of the updated quality policy of the National Institute of Pharmacy.
16th of June 2008, Budapest
