Scientific and Methodological Rationale for Developing a Standard Operating Procedure for In-Pharmacy Quality Control Using 0.02% Sterile Furacilin Solution as an Example

Background: The extempore preparation of medicinal products in pharmacy organizations, along with the implementation of in-pharmacy quality control, ensures compliance with the regulatory requirements of the Ministry of Health of the Russian Federation, particularly those related to drug quality assurance. This article describes the development process of a standard operating procedure for in-pharmacy quality control of 0.02% sterile furacilin solution in accordance with current legislative and regulatory acts governing the preparation and quality control of medicinal products.

AIM: to develop a standard operating procedure for the in-pharmacy quality control of a medicinal product—using 0.02% sterile furacilin solution as an example—prepared in pharmacy organizations authorized to manufacture aseptic medicinal products, including those under the jurisdiction of the Ministry of Health and the Ministry of Defense.

MATERIALS AND METHODS: The study applied a systems-based and problem-oriented methodological approach using content analysis, structural–functional analysis, logical analysis, and comparative and descriptive methods.

RESULTS: In accordance with current quality requirements for medicinal products, testing procedures based on physicochemical and chemical methods were proposed. A list of instruments, laboratory glassware, auxiliary materials, and reagents required for chemical quality control was also compiled. The proposed standard operating procedure may serve as a methodological guide for pharmacy organizations authorized to produce aseptic medicinal products within both civilian and military healthcare systems. It can be used for in-pharmacy quality control of 0.02% sterile furacilin solution and as a model for developing similar standard operating procedures.

CONCLUSION: The authors emphasize the necessity of implementing in-pharmacy quality control procedures in accordance with the updated requirements of the State Pharmacopoeia of the Russian Federation, 15th edition. Proper execution of control procedures is expected to enhance the production activities of civilian and military pharmacies, thereby contributing to improved effectiveness of medical care delivery.