Development of standard operating procedures and their introduction in compounding pharmacies

Abstract

In accordance with the requirements of good manufacturing practices a proper keeping of documentation in compounding pharmacies licensed to prepare medicines should be an integral part of the quality assurance system and be a key element at all stages of preparation and quality control of compounding preparations. One of the important elements of proper documentation is the practice of using standard operating procedures (SOPs). The aim of this article is to describe the methodology of the SOP developing for licensed compounding pharmacies. Standard procedures should be developed according to the current regulatory framework and research. SOPs are developed by the staff involved in introduction of this procedure. SOPs should be reviewed by responsible persons and approved by the head. The following SOP structural elements have been identified: the title page (the name of institution, the name of the SOP, the classification number, the SOP version, the date on which the SOP enters into force, the signature of the responsible person); the goal; the scope of application; responsibility; stages of the procedure; revision (the term when the SOPs should be reviewed). The organizational structure of the quality assurance system is proposed for the SOP systematization: quality assurance, personnel, facilities and equipment, documentation, technology of preparation, quality control, carrying out works under the contract, complaints and recall, self-inspection. For each of the sections it has been proposed to develop SOPs focused on ensuring compliance with the procedure and to provide the quality aspect, which is the subject in this section.