Application of HACCP for development of quality risk management in a water purification system

Abstract The present work reports the implementation of the Hazard Analysis Critical Control Point (HACCP) methodology to analyze the water purification system of a pharmaceutical site, in order to assure the system quality and prevent failures. As a matter of fact, the use of HACCP for development and implementation of Quality Risk Management (QRM) is not usual in pharmaceutical plants and it is applied here to improve the performance of the water purification system of a polymerization pilot plant used to manufacture pharmaceutical grade polymer microparticles. Critical Control Points (CCP) were determined with the aid of a decision tree and questions were made to characterize whether identified hazards constitute actual CCPs and should be monitored. When deviations were detected, corrective actions were performed and action plans were used for following-up and implementation of corrective actions. Finally, microbiological and physicochemical parameters were analyzed and the obtained results were regarded as appropriate. Therefore, it is shown that HACCP constitutes an effective tool for identification of hazards, establishment of corrective actions and monitoring of the critical control points that impact the process and the quality of the final pharmaceutical product most significantly.

Profile of blood donors who presented adverse reactions to the donation / Perfil de los donantes de sangre que presentaron reacciones adversas a la donación / Perfil dos doadores de sangue que apresentaram reações adversas à doação

ABSTRACT Objective: identify the adverse reactions presented by blood donors and outline their sociodemographic profile. Method: a quantitative, cross-sectional retrospective study of 780 records of blood donors from a public hemocenter in the southern region of Brazil, from December 2015 to January 2016. For the analysis the descriptive statistics was used. Results: it was identified that throughout 12 months, the total blood donors corresponded to 27,300 people, in which 780 developed at least one reaction. They were characterized by female and recurrent donors, single, with a complete average level of education, ranging from 16 to 30 years, who triggered between 1 and 3 reactions. Mild reactions were more frequent, followed by moderate and severe reactions. Conclusion: There is a high rate of adverse reactions from donors emphasizing the need for changes in hemotherapy care practices.

RESUMEN Objetivo: identificar las reacciones adversas presentadas por los donantes de sangre y trazar su perfil sociodemográfico. Método: una investigación cuantitativa, retrospectiva transversal, realizada en 780 registros de donantes de sangre de un hemocentro público de la región sur de Brasil, en el período de diciembre de 2015 a enero de 2016. Para el análisis se procedió a la estadística descriptiva. Resultados: se identificó que, en el período de 12 meses, el total de donantes de sangre correspondió a 27.300 personas, en el cual 780 desarrollaron al menos una adversidad. Se caracterizaron por donantes de repetición, del género femenino, solteros, con nivel de escolaridad promedio completo, en el grupo de edad de 16 a 30 años, que desencadenaron entre 1 y 3 adversidades. Las reacciones lleves fueron más recurrentes, seguidas de las reacciones moderadas y graves. Conclusión: se señala un alto índice de reacciones adversas por parte de los donantes enfatizando la necesidad de cambios en las prácticas de los cuidados en hemoterapia.

RESUMO Objetivo: identificar as reações adversas apresentadas pelos doadores de sangue e traçar o seu perfil sociodemográfico. Método: pesquisa quantitativa, retrospectiva transversal, realizada em 780 registros de doadores de sangue de um hemocentro público da região sul do Brasil, no período de dezembro de 2015 a janeiro de 2016. Para análise procedeu-se à estatística descritiva. Resultados: identificou-se que, no período de 12 meses, o total de doadores de sangue correspondeu a 27.300 pessoas, no qual 780 desenvolveram ao menos uma adversidade. Caracterizaram-se por doadores de repetição, do gênero feminino, solteiros, com nível de escolaridade médio completo, na faixa etária de 16 a 30 anos, que desencadearam entre 1 e 3 adversidades. As reações leves foram mais recorrentes, seguidas das reações moderadas e graves. Conclusão: Aponta-se um alto índice de reações adversas por parte dos doadores enfatizando a necessidade de mudanças nas práticas dos cuidados em hemoterapia.