Evaluation of the documentation for OPV production in the year of 2006

ABSTRACT

Background: Good Manufacturing Practice (GMP) is a important part of quality assurance (QA). Implementation of GMP request to establish the documentation system and should be reviewed as well as evaluated strictly. Documentation is important because it helps the competent person make decisions whether to finish the product or not and it is used as a base for inspection. In the year of 2006, 100% OPV production line in Center for research and production of vaccines and biologicals (POLYVAC) had established the document system. Objectives: To evaluate of the documentation for OPV production in the year of 2006 in POLYVAC. Subjects and method: Documentation for OPV production in 2006 were evaluated by standard operating procedure (SOP) (recommended by WHO). The standards included blank space; erase; code and unit of measurement; revision; no signage and others. Results and Conclusion: Documentation is different between departments. Onlymonkey ranch in Reu island applied 100% SOP. 776 errors were found. Among them blank space (32.2%), erase (27%), code and unit of measurement (21%), revision (5%), no signage (12%) and others (3.6%). The results were the basis of promoting implementation of GMP in vaccine manufacturing in POLYVAC.