Implementar un proceder para la obtención de los reactivos hemoclasificadores policlonales ABO en el banco de sangre provincial de Cienfuegos
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Fecha
2006-06-25
Autores
Torres González, Lilian
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Universidad Central "Marta Abreu" de las Villas
Resumen
Con el objetivo de elevar la calidad de los reactivos hemoclasificadores policlonales ABO, se realizó una amplia revisión bibliográfica para implementar un proceder que permitiera la manufactura del producto con el cumplimiento de las Buenas Prácticas de Laboratorio Clínico, y las Buenas Prácticas de Producción en el departamento de Producción del Banco de Sangre Provincial de Cienfuegos.
Se diseñaron y elaboraron los documentos que forman parte del sistema de documentación, entre ellos: el procedimiento normalizado de operaciones, los documentos para la recolección de los datos, así como los registros de trazabilidad, modelos de solicitud de ensayos microbiológico y funcional y el protocolo de liberación.
En el departamento de Aseguramiento de la Calidad se introdujeron los ensayos funcionales establecidos por el CEDMED para la evaluación de los reactivos hemoclasificadores policlonales y monoclonales del sistema de grupos sanguíneos humanos ABO1 , con el propósito de determinar de la calidad del lote del reactivo anti-AB policlonal . Se entrenó al personal responsable de esta actividad en el uso de estos métodos de evaluación del producto terminado.
Los resultados de los ensayos funcionales fueron satisfactorios debido a que cumple con los requisitos de potencia, avidez y especificidad. Además se evaluó en paralelo con el reactivo anti-AB de origen monoclonal producido por Centics Diagnóstico en cuanto a potencia, avidez e intensidad de la reacción en los cuales demostró ser eficaz como reactivo hemoclasificador.
With the objective of rising up the quality of the serums blood grouping reagent ABO, It was carried out a wide bibliographic checking, to put in practice a new procedure which permits the product is manufacturing , taking into consideration a good practice of clinic laboratory and a good manufacturing practice at the Production Department from the Blood Banks at Cienfuegos Province. There were designed and produced the documents which take part of the documentation system between them. The Normalized Procedure for Operation, the documents for the recollection of data, as well as the registers of trace ability ,the analysis request models, microbiological and functional. The were introduce, functional essays at the quality assurance department which were establish by CEDMED, for the evaluation of the Policlonal and Monoclonal human blood grouping reagent system ABO. Which the objective of determined the quality of the anti-AB policlonal reactive lot. The responsible persons for this activity has been well trained for using this evaluative methods of defined products. The functional essays results were satisfactory due to the potent, avid and specific requirement were not violated. Besided that it was evaluated parallel with the anti-AB reactive from monoclonal origin produced by Centics Diagnósticos taking into consideration. The potent, avid and intensity of the reaction in which it showed to be very efficient as an blood grouping reagent.
With the objective of rising up the quality of the serums blood grouping reagent ABO, It was carried out a wide bibliographic checking, to put in practice a new procedure which permits the product is manufacturing , taking into consideration a good practice of clinic laboratory and a good manufacturing practice at the Production Department from the Blood Banks at Cienfuegos Province. There were designed and produced the documents which take part of the documentation system between them. The Normalized Procedure for Operation, the documents for the recollection of data, as well as the registers of trace ability ,the analysis request models, microbiological and functional. The were introduce, functional essays at the quality assurance department which were establish by CEDMED, for the evaluation of the Policlonal and Monoclonal human blood grouping reagent system ABO. Which the objective of determined the quality of the anti-AB policlonal reactive lot. The responsible persons for this activity has been well trained for using this evaluative methods of defined products. The functional essays results were satisfactory due to the potent, avid and specific requirement were not violated. Besided that it was evaluated parallel with the anti-AB reactive from monoclonal origin produced by Centics Diagnósticos taking into consideration. The potent, avid and intensity of the reaction in which it showed to be very efficient as an blood grouping reagent.
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Palabras clave
Buenas Prácticas de Laboratorio Clínico, Banco de Sangre Provincial, Cienfuegos, CEDMED