AC 2005 Vol-1.pdf - Cecmed - Infomed
AC 2005 Vol-1.pdf - Cecmed - Infomed
AC 2005 Vol-1.pdf - Cecmed - Infomed
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123 Trabajo experimental<br />
Table 4. Evaluation of the impact of training and data review. The in vivo evaluation of Hepatitis B vaccine<br />
started in 2001.<br />
Vaccine tests<br />
Non - valid<br />
tests<br />
Number of tests by year<br />
2000 2001 2002 2003<br />
In vitro potency tests for Hepatitis B vaccine 1 5 25 10 8<br />
In vivo potency tests for Hepatitis B vaccine 1 - 2 4 5<br />
Potency, identity and thermostability test for Polio vaccine 0 10 22 5 15<br />
Table 5. Development of self-inspections.<br />
Quality System activities Routine inspection Follow up inspection Compliance of corrective actions<br />
Equipment x x 40 %<br />
Documentation x x 70 %<br />
Reference materials x x 100 %<br />
Personnel x - -<br />
Test items x x 98%<br />
Viral tests x x 100 %<br />
Animal tests x x 70 %<br />
Bacterial tests x x 98%<br />
Table 6. Results from the HbsAg collaborative study. The cut - off value was 0.135.<br />
Preparation<br />
Result/Response<br />
Replicate 1 Replicate 2 Recommended value<br />
Panel 1 30.5 UI/ml<br />
29.7 UI/ml<br />
30 UI/ml<br />
(28.1-33.1)<br />
(27.1-32.6)<br />
Panel 2 6.17 UI/ml<br />
6.65 UI/ml<br />
6.7 UI/ml<br />
(5.35-6.99)<br />
(5.79-7.52)<br />
Panel 3 1.73 UI/ml<br />
1.60 UI/ml<br />
2.3 UI/ml<br />
(1.24-2.31)<br />
(1.13-2.17)<br />
Panel 4 0.47 UI/ml<br />
0.42 UI/ml<br />
0.5 UI/ml<br />
(0.17-1.23)<br />
(0.13-1.26)<br />
Panel 5 NR (non reactive) NR 0.13 UI/ml<br />
Panel 6 NR NR Negative control
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