Implementación documental de buenas prácticas de almacenamiento, distribución y transporte para la empresa ONCOMAX CIA LTDA en base a la norma ARCSA DE-002-2020-LDCL como sistema de gestión de calidad

Abstract

The processes of storage, distribution and transport of medicines have a direct impact on the health and safety of patients, which is why different government entities have been established in charge of monitoring compliance with Good Manufacturing, Storage and Distribution Practices (BPADT). In Ecuador, the National Agency for Regulation, Control and Sanitary Surveillance (ARCSA) is in charge of monitoring said compliance in order to grant certification and operating permits to pharmaceutical establishments that comply with this requirement. With the above, the purpose of this research is to implement the documentary part of the Quality System "Good practices for storage, distribution and transport of medicines" at the new address of the company ONCOMAX CIA LTDA according to regulatory requirements RESOLUTION ARCSA-DE-002 -2020-LDCL, which will benefit the planning, control and improvement of the activities carried out in the distributor with the purpose of guaranteeing quality, safe and effective medicines throughout the distribution chain. In the first instance, an initial diagnosis of the storage, distribution and transport processes was carried out in the company ONCOMAX CIA LTDA. through the verification guide (check list) of Resolution ARCSA-DE-002-2020-LDCL. Subsequently, based on the results obtained in the initial diagnosis, missing procedures were drafted and the existing ones were updated according to the requirements of Resolution ARCSA-DE-002-2020-LDCL, which will serve to obtain the BPADT Certification before the Authority. Sanitary (ARCSA), certification that