Elaboración de Procedimientos Operativos Estandarizados para la formulación de preparados oficinales semisólidos en el laboratorio de fórmulas magistrales y oficinales de la Facultad de Ciencias, ESPOCH.

Abstract

The objective of the research was to develop Standardized Operating Procedures (SOPs) for the formulation of semi-solid officinal preparations in the laboratory of magisterial and officinal formulas of the Faculty of Sciences-ESPOCH. SOPs were performed highlighting basic operations in the laboratory, ranging from validation of the medical prescription to dispensing the master preparation, considering the characteristics of each area and under the criteria of national and international standards for the preparation and quality control of the master preparations. It was systematically developed through the following phases: Initial evaluation of the laboratory, Preparation of the SOPs, Pilot application of the SOPs in the laboratory and Training for teachers, technicians and students. In the initial evaluation, the analyzed parameters showed that 56.6% presented non-conformities within the laboratory, the main problem being the lack of documentation and recording of the activities generated during the entire process of preparing the semi-solid preparations. The development and pilot application of SOPs evidenced compliance with activities in each area within the laboratory, reaching 87.75% compliance. The pilot application of SOPs allowed the activities to be carried out in a simple way, so the staff understood specifications in each process on time. The importance of SOPs within the laboratory guaranteed the maintenance of quality and service levels, demonstrating through records, the control of each process, minimizing errors and ensuring the traceability and quality of the formulations produced. It is recommended to continue developing SOPs for the development of new pharmaceutical forms that contribute to the needs of each patient.