Utilização de técnica de análise de risco numa unidade de produção de proteínas recombinantes: estudo de caso da ferramenta de análise de risco - HAZOP

Abstract

In November 2005, with the guidance of the Quality Risk Management (Q9) the International Conference on Harmonization (ICH) in conjunction with regulatory agencies in the United States, Japan and Europe started recommending applying risk management for regulation of the pharmaceutical industry. Following this argument, the National Health Surveillance Agency (ANVISA) published the Board Resolution RDC 17/2010 which establish the Good Manufacturing Practices in Pharmaceutical Manufacturing, allowing the commercialization of pharmaceutical products. This resolution states to perform the production process validation on a risk analysis basis. Following the guidelines, this work intend to use the risk analysis tool Hazards and Operability Studies HAZOP in a bacterial bioreaction system for recombinant protein installed in Bio-Manguinhos/Fiocruz. This system consists of 100 (FE01) and 600 (FE02) liters fermenters, a harvest tank of 600 Liters (HT01) and a 600 Liters tank for culture media preparation (MT01). By applying, this tool was possible to classify the system risk identifying nodes, primary and secondary (deviations) guidewords, as well as, the severity and frequency of events. Thus, ones identified 82 risks within FE01 and FE02 fermenters, with 8.5% being irrelevant risks, 65.9% acceptable risks and 25.6% undesirable risks. In the harvest tank HT01 were identified 55 risks, which 14.5% are significant, 67.3% are acceptable and 18.2% undesirable. For media preparation tank, MT01 were identified 66 risks divided into 9% negligible risks,69.7% acceptable risks and 21.3% of unwanted risks. With these data, it is possible to ensure that there was not fatal risks that could harm the manufactured equipment, but only operation of this equipment during production routine and continual improvement cycle can validate this prospective study