Lebedynets V. Methodology of quality management systems formation at the enterprises for medicines producing

For the first time have been summarized and systemized the principles and methods of quality management systems formation in enterprises for producing of medicines and areas of improvement and development of such systems have been offered. A methodology has been offered for modeling process-oriented QMS focused on the implementation of modern regulatory requirements for the operation ofsuch systems at the enterprises for medicines producing (EMP), using the method of structural analysis and design (SADT) in IDEF0 notation. Scientifically substantiated the ways of implementing the PDCA ("Plan-Do-CheckAct") methodology to process execution algorithms at EMP QMS and relevant documented procedures governing them. The concept of EMP organizational structure adaptation to process structure of implemented EMP QMS has been developed and proposed, and offered the typical model of an EMP organizational structure in correlation with the QMS process architecture. The essence has been explained, specified the meaning of "process approach" concept regarding EMP QMS and also suggested scientific approach to the definition of inputs and outputs of QMS processes as initial and final objects of information and / or material transformation. Organizational principles, directions and priorities have been identified, on which it is reasonable develop and improve an EMP QMS.