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.

Estudo comparativo da reação inflamatória renal entre álcool de polivinil - flocular e álcool de polivinil + acetato de polivinil - esférico: estudo experimental / Comparative study of renal inflammatory reaction between irregular - polyvinyl alcohol and spherical - polyvinyl alcohol + polyvinyl acetate: experimental study

OBJETIVO: Avaliar as características e os efeitos de um agente embólico, disponível comercialmente, consistindo de Polivinil Alcool (PVA) de morfologia flocular, e comparar com um agente esférico, de tecnologia nacional, consistindo de Polivinil Alcool e Polivinil Acetato (PVA + PVAc). MÉTODO: Foram utilizadas fêmeas de coelho albino "New Zealand", submetidas à embolização arterial renal. PVA-flocular foi usado em 24 animais, assim como PVA+PVAc-esférico. Seis animais foram utilizados como controle. Todos foram mantidos em cativeiro até a morte, por períodos pós-operatórios de 48 horas, cinco dias, 10 dias e 30 dias. RESULTADOS: Ambos os agentes promoveram oclusão do vaso e infarto do órgão. O estudo microscópico inicial das artérias embolizadas com PVA-flocular, mostra oclusão com trombo e PVA. Os vasos embolizados com PVA+PVAc-esférico, mostram os agentes ocupando praticamente todo o lúmen. No estudo de 30 dias, observa-se absorção do trombo e retração dos agentes de PVAflocular, criando espaços. E com PVA+PVAc-esférico, pode-se observar os agentes circundados por intensa fibrose. CONCLUSÕES: Ambas as partículas foram efetivas para causar isquemia tecidual. A reação inflamatória foi mais intensa com PVA+PVAc-esférico que também apresentou grau de penetração maior no sistema vascular.

BACKGROUND: To evaluate the characteristics and the effects of an embolic agent, available commercially, consisting of irregular - Polyvinyl Alcohol (PVA), and to compare with a spherical agent, of brazilian technology, consisting of Polyvinyl Alcohol and Polyvinyl Acetate (PVA + PVAc). METHODS: Renal arterial embolization was performed in females of New Zealand White rabbits. Irregular - PVA was used in 24 animals. Spherical - PVA+PVAc was used in 24 animals. Six animals were used as control. All animals were maintained in captivity until the euthanasia, after 48 hours, 5 days, 10 days and 30 days. RESULTS: Both agents resulted in vessel occlusion and organ infarction. The initial macroscopic study of the arteries embolized with irregular-PVA, the occluding plug consisted of thrombus and PVA. In vessels embolized with spherical-PVA+PVAc, the occluding plug consisted mostly of the embolic agent. After 30 days, there is absorption of the thrombus and retraction of the agents of PVA-irregular, creating spaces. With spherical-PVA+PVAc, it can be observed the agents surrounded by intense fibrosis. CONCLUSION: Both particles were effective to cause tissue ischemia. The inflammatory reaction was more intense with spherical-PVA+PVAc, besides presenting larger degree of penetration in the vascular system.