[Documentation of good distribution practice of medicines and its implementation in Lithuanian drug distribution companies].
Good Distribution Practice of medicinal products for human use is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended human consumption. A drug is a specific product and its mishandling is dangerous to human health and life. Therefore it is necessary to strictly control the movement of the drug from the producer to the consumer so that poor quality drugs do not have access to the market. Good Distribution Practice rules set the general requirements for good wholesale distribution practice of drugs, intended for human consumption. In order for company to meet the specified requirements, the drug distribution company must have all suitable and necessary premises, machinery, equipment, the required number of employees and specified documentation. The preparation of the Good Distribution Practice documentation is one of the most important and complex aspects when implementing the Good Distribution Practice in the companies. The article deals with the analysis of results obtained during the research of drug distribution companies in Lithuania. The research revealed that drug distribution companies put emphasis on the equipment of storage premises. Less attention is being paid to the preparation of the documents of Good Distribution Practice. The article thus presents the analysis of Good Distribution Practice documents prepared by the drug distribution companies.
Draksiene
Gailute
G
Department of Drug Technology and Pharmaceutical Management, Kaunas University of Medicine, Kaunas, Lithuania. gailute.draksiene@mail.lt
Petkevicius
Henrikas
H
Radziūnas
Raimondas
R
D004282:Documentation / Q000592:standards; D004356:Drug Storage / Q000592:standards; D005062:European Union; D006801:Humans; D008097:Lithuania; D004364:Pharmaceutical Preparations / Q000592:standards*; D010594:Pharmacies / Q000592:standards*; D017410:Practice Guidelines as Topic; D012106:Research; D011795:Surveys and Questionnaires
D004364:Pharmaceutical Preparations