Articulación del sistema de gestión de calidad (SGC) de SUGOI PACKING SAS respecto a su servicio de acondicionamiento secundario de medicamentos, apoyados en las Buenas Prácticas de Manufactura (BPM), integradas a las directrices de la norma ISO 9001:2015

Abstract

Sugoi Packing SAS, was born as a company for secondary packaging of pharmaceutical products in the city of Bogotá 15 years ago, to carry out this work, from the beginning it had to have the BPM certificate. This certification is valid for 5 years according to Article 7 of Decree 549 of 2001 of the Ministry of Health. The secondary packaging of medicines is established and regulated in Colombia by the Good Manufacturing Practices (GMP). Bearing in mind that this process is part of the marketing of the product and that the containers, signs, labels and packaging are an integral part of the medicine, since they guarantee its quality, stability and proper use (INVIMA 2021). Taking into account the growth and new needs of the market, Sugoi Packing expanded the scope of its packaging services for other products, such as medical devices, which are regulated by INVIMA Decree 4725 of 2005, which established the Certificate of Storage and Conditioning Capacity (CCAA) and for cosmetic products regulated by INVIMA Resolution 3773 of 2004, which established the Cosmetics Production Capacity Certificate (CCPC). These last two services have been the company's main source of income in recent years. Taking into account the above, Sugoi Packing did not see the need to renew the BPM certification, obtained in its beginnings as a company once its term ended and dedicated its services in recent years to the secondary packaging of medical devices and cosmetic products. Currently, the difficulty of access to clients that require the secondary packaging of medicines is presented, limiting the growth of the organization, due to this the need arises to re-implement a system based on Good Manufacturing Practices (GMP), taking into account that this certificate is required as a legal requirement by the Ministry of Health and Social Protection, to operate as a company that provides the service of secondary packaging of medicines in Colombia.