GLP is the system of quality issues which deals with organizing and making non-clinical and environmental assurance investigations; it includes planning, execution, control, certification, archives and issuing final report.
To control the appropriate work of the research places whether they follow the GLP requirements, to determine the GLP levels of particular investigations, and to keep the requirements met are duties of the National Institute of Pharmacy –as the competent and responsible authority.
Arrangement of GLP inspections
A local inspection is carried out by the GLP inspectors of the competent authority at the research place in the course of which the level of meeting the GLP requirements is supervised and controlled on the basis of the investigation reports and all the available data. The research place and the GLP level of a particular investigation is then assessed according to the results of the supervision.
The competent authority gives their decision about the GLP assessment of the research place – it is issued in Hungarian and in English as well. If the research place is considered not to meet the requirements of the GLP criteria the competent authority will withdraw the granted GLP assessment in a decision. The identifying data of the research place, the type of the investigation, and the data concerning GLP correspondence are included in the GLP assessment report which are published annually by the Ministry of Health and the Ministry of Agriculture and Rural Development.
The data coming to the GLP inspectors’ and the competent authority’s knowledge during their work are handled confidentially according to the relevant laws.
The research places owning GLP assessment are controlled at least once in every 3 years by the GLP inspectors.
According to the decision on the GLP assessment and withdrawal the competent authority issues an annual compilation in English about the research places falling within the competence of the GLP inspection programme. This compilation is to be sent to the concerned international organizations and to the GLP authorities operating in the OECD (Organization for Economic Cooperation and Development) member states. Upon request of these organizations the competent national authority gives further information about the details of the programme stated in the supplement documents, about the construction of the competent authority, the number of GLP inspectors and their practice.