AC 2005 Vol-1.pdf - Cecmed - Infomed

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119 Trabajo experimental Collaborative studies We have been involved in two collaborative studies. We developed a collaborative study concerning of the in vitro potency test for Hepatitis B vaccine in order to demonstrate that our test could monitor the manufacturer’s results. We sent to the Cuban manufacturer (CIGB) blinded samples of 10 batches and evaluated whether there was a significant correlation between both methods. For in vitro potency test CIGB and our lab used a method based on the same principle (a previous neutralization step and a subsequent ELISA for determining anti- HbsAg antibodies), but CIGB used their own reagents [7] meanwhile we used anti- HbsAg Hepanostika kit from Organon Teknika [5]. The other collaborative study was a part of the study (Phase 2) for the characterization of the candidate WHO reference panel for Hepatitis B surface antigen (HbsAg). The Phase 1was performed by the Working Group on Hepatitis and HIV Diagnostic Kits by calibration of the most concentrated panel member against for the First International Standard for HbsAg (NIBSC Code 80/549). The aim of this study was to characterize the reference panel in a wide range of HbsAg detection kits, which are in use around the world. The panel members sent by NIBSC were reconstituted in 1 mL distilled water as described in the study Protocol. These members were treated as typical test samples and assayed in duplicate as recommended by the manufacturer [7]. The testing was repeated on three separated days. Raw data were returned to NIBSC for processing. Control Charts We established a Control Chart for the Hepatitis B vaccine standard (a Regional Standard) used for in vitro potency test. We selected ED 50 of the standard as a parameter for monitoring the performance of the potency. The Control Chart was built using Microsoft Excel and we analysed the results following the Finney’s method [8]. Results and Discussion The implementation of a Quality Assurance Program is a vital step to ensure the reliability of test results. As shown in Tables 1, 2 and 3, the evaluations performed were successful because all the criteria of competence were fulfilled. For Polio test, the difference between replicates for each vaccine component (including thermostability) was no longer than 0.5log10 whereas for Hepatitis B test the variability between analysts was lower than 20% (CV=11.05%). In both cases, the results were within the expected range. The impact of training and data review on the quality control testing is shown in Table 4. For Polio and Hepatitis B vaccines, we have performed 111 potency tests so far, and only the 1.8 % have resulted non-valid tests. According to these results, it’s evident training and data review is a powerful method for monitoring the operator performances and assuring the lab results. As shown in Table 5 we have performed 15 self-inspections, including routine and follow up inspections. Analysis of Table 5 shows successful compliance of corrective actions for the majority of Quality System activities. In the case of equipment, the lower percent of compliance is due to the lack of resources to deal with the deviations detected. In general, this result is evidence of the capacity of selfinspections to identify deviations and take corrective actions. Self - inspections has
120 Trabajo experimental enabled our laboratory to deal swiftly and effectively with deviations revealed by internal audits undertaken by the Quality Assurance Department. Fig. 1 and Tables 6 and 7 illustrate the results derived from the collaborative studies. As shown in Fig. 1, there was a significant correlation between the in vitro method performed by CIGB and by our laboratory (r=0.96, p
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ANUARIO CIENTÍFICO 2005 Volumen 1
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Consejo Editorial Presidente Dr.C.
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DESARROLLO E IMPLEMENTACIÓN DEL SI
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Editorial Presentamos a continuaci
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Base científica del desarrollo...
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Revisión sobre el factor... 19 des
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trombocitopenia asociada con su uso
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Revisión sobre el factor... 23 sti
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Mecanismos de acción... 25 MECANIS
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Mecanismos de acción... 27 Kroning
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Mecanismos de acción... 29 intraci
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Métodos para la evaluación... 31
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Consideraciones para la... 41 crite
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Consideraciones para la... 43 Un mo
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Evaluación económica de... 45 EVA
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Evaluación económica de... 47 exi
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Evaluación económica de... 49 eva
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Evaluación económica de... 51 Dis
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Evaluación económica de... 53 ven
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Prevalencia de pseudomonas... 55 Es
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Prevalencia de pseudomonas... 57 Ta
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Prevalencia de pseudomonas... 59 en
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Prevalencia de pseudomonas... 61 GE
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Prevalencia de pseudomonas... 63 ho
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Prevalencia de pseudomonas... 65 Ta
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Delimitación entre medicamentos...
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Page 77 and 78: Desarrollo e implementación... 77
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Page 93 and 94: 3 HEBER BIOTEC S. A. Caracterizaci
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Page 147 and 148: 138 Trabajo experimental % seroconv
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Page 167 and 168: 158 Trabajo experimental DISEÑO Y
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171 Trabajo experimental integraci
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Control de la documentación... 169
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Recibido: 10 de septiembre de 2004
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Actividad Académica 179 Informativ
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Actividad Académica 181 SIDA. Prog
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Actividad Académica 183 Docencia N
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Actividad Académica 185 con 25 par
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¿Còmo publicar?... 187 objetivos.
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