Good manufacturing practices in the preparation of natural medicine in the Colmena

Abstract

The use of natural products for medicinal use has increased in recent years worldwide, Ecuador has followed this trend, many of these products are freely marketed, without a guarantee of safety since a large part of them do not have a certification of Good Manufacturing Practices (GMP), which is a mandatory parameter for any industry that produces natural products for medicinal use. The present article shows the steps to follow from the initial internal audit to verify the status of the company La Colmena based on the Check List which is granted by ARCSA, Ecuador (Agency for Regulation and Sanitary Control) where list the points to be met to obtain the BPM certification and its measures to correct the non-conformities found. The company La Colmena presented 25% of successful parameters in the initial internal audit, once the corrective actions were carried out, 83% compliance was presented, which guarantees that the company provides the market with quality and safe products for consumption. This work aims to develop a GMP protocol to be a guide for other companies in the same sector and qualification.