H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, Fax: (1) 8869-460

Mail: 1372 P.O. Box: 450.

MAGYAR

Inspection

Good Manufacturing Practice (GMP) is part of the quality assurance system to enable the medicinal products to be manufactured and controlled according to the requirements prescribed, the facts stated in the Manufacturing Authorisation and to be appropriate for the purpose they have been granted.

Good Laboratory Practice (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.

Good Clinical Practice (GCP) is the system of internationally accepted ethical and scientific requirements which have to be taken into consideration during planning, executing, certifying and reporting any human clinical trial – it includes bioavailability and bioequivalence investigations as well. The human rights, safety and protection of state of health of the participants are provided by meeting the requirements of GCP. It also ensures that the trials are well-established and valid.

Good Distribution Practice (GDP) is part of the pharmaceutical quality assurance which enables the medicinal products having been released by the manufacturer before putting on the market to be handled by detailed certification (to be controlled, transported and stored). The medicinal products should also keep their original quality until the date of expiry and hereby meet the requirements included in the Marketing Authorisation and be appropriate for use.

Pharmacovigilance Inspection is a system of quality issues which ensures the Marketing Authorisation Holder meeting the requirements stated in laws and directives about following the safety of authorised medicinal products with attention.
Last updated: 2012.10.04 14:28