Keywords
Health Surveillance
quality control
production consistency of biological
chart control
How to Cite
Abstract
This study aimed: (i) at evaluating the process of quality control related to yellow fever vaccines used by the National Immunization Program (NIP) of the Brazilian Ministry of Health during the period from 2000 to 2008, by using survey data from the Sample Management System (SMS) of the National Institute for Quality Control in Health (INCQS) - Oswaldo Cruz Foundation (Fiocruz); and (ii) to propose the use of control charts, as useful tools for improving the processes of consistency of production and detection of systematic biases. The analysis to check the quality control of vaccines against yellow fever was comprised of the following parameters: (i) potency testing, (ii.) thermo stability, (iii.) residual ovalbumin contents (iv.) bacterial and fungal sterility assay, (v.) residual humidity contents, (vi.) bacterial endotoxin, and (vii.) vaccine production and respective quality control protocols stated by manufacturers. During the analyzed period, 1,031 yellow fever vaccine batches were analyzed by INCQS, which were produced by two manufacturers (97% by manufacturer A and 3% by manufacturer B), representing a total of 285 million individual doses. The present study indicates that at INCQS the process is under statistical control, and the specific causes of variation, if they eventually occur, are reasonably managed.
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