ORGANIZATION OF CORRECTIVE AND PREVENTIVE ACTIONS IN PHARMACEUTICAL QUALITY SYSTEM. PART I
In article requirements for corrective and preventive action shown by ISO 9001 and ICH Q10 are analyzed. Importance of such actions for continuous improvement of the pharmaceutical company is proved. The problems associated with the organization of corrective and preventive actions in domestic enterprises for the production of medicines are allocated. The basic approaches to the rational organization, regulation and documentation of corrective and preventive actions are shown.