PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION

The article is devoted to the development of quality system documents for pharmacy organization. legislation Republic Belarus, as well Eurasian Economic Union, requires and maintenance assurance system, management pharmaceutical in a organization, distributor or manufacturer medicinal products. presents comparative analysis regulatory requirements approaches international standards ISO series construction systems processes documentation. Such Quality Manual its equivalent, Standard Operating Procedures (SOP) Process Instructions are most difficult develop. distribution responsibility within organization understand. On example RUE «BELPHARMATSIYA» it shown how can be documented their implementation stated. functioning depends on clarity documentation structure circulation It authorities maintain effective this system.