Advances in Good Manufacturing Practice guidelines for sterile pharmaceutical products

Abstract

The microbiological contamination of medicines represents a significant risk to the patient. The control of microbial contamination must cover all stages of product development. Recently, the Annex 1 of the European Medicines Agency (EMA), which deals with Good Manufacturing Practices for sterile medicinal products, has been revised in collaboration with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and the World Health Organization (WHO). This study aimed to discuss the main aspects of the revision of Annex 1 of the EMA, comparing it to national normative acts,
focusing on aseptic processing and control of clean areas to manufacture sterile drugs. To this end, a comprehensive search was carried out in electronic health regulatory sites and scientific databases to retrieve material on the subject. With the publication of Annex 1 of the EMA, there is a great tendency to update Brazilian norms related to good practices in the manufacture of medicines. When comparing the current normative acts, such as RDC 658/2022 and IN 35/2019, given the publication of Annex I of the EMA, a high normative impact is observed, either due to the greater detailing of essential items or the introduction of new requirements. Following the assumptions of Good Manufacturing Practice, establishments are expected to improve their processes increasingly, in addition to regulations, aiming to mitigate the risks inherent in any manufacturing process, providing safe and effective medicines to the entire population.