Validation of production processes in the pharmaceutical industry: brief history and current aspects

Abstract

The validation of production processes in the pharmaceutical industry is part of a set of standards and tools used to ensure the quality of pharmaceutical products, being an integral part of Good Manufacturing Practices (GMP). This work aims to contextualize the history and concepts involved in the production validation processes in Brazil, from the creation of the National Health Surveillance Agency (Anvisa) to the present day. Anvisa’s Resolutions published on the subject, guides from the International Council of Harmonization (ICH), and other references related to the matter, which are available in PubMed and Scielo databases, were evaluated. Through the analysis carried out, it is noticeable that the level of complexity involved in the validation of productive processes has increased since the first Resolution of the Collegiate Board (RDC) no. 134 of 2001 which addressed concurrent and prospective modes related to processes and products, as well as a retrospective format based on historical product data. With the updates, namely: RDC no. 210/2003, RDC no. 17/2010, RDC no. 301/2019, and RDC no. 658/2022, the use of quality management tools was improved, with the verification of processes, through analytical and statistical tools. In this way, it is necessary to maintain the constant improvement of both the production processes and their regulation and the research and dissemination of knowledge involved in the manufacture of medicines.