Tarasevich State Institute for Standardization and Control of Medicinal Immunobiologic Preparations, Moscow, Russia
Aim. To assess the consistency of technological process of manufacture of DTP vaccine’s pertussis component on the basis of its immunogenicity using Shewhart’s cards. Materials and methods. Published data of domestic plants belonging to public corporation Mechnikov «Biomed» and Ufa branch of scientific-production organization «Immunopreparat» ingressed in «Microgen» enterprise were used. Immunogenicity of DTP vaccine pertussis component was studied. Results. It was revealed that technological process of manufacturing of DTP vaccine’s pertussis component on production plants was not always in statistically controlled state. Conclusion. Obtained data showed that it is reasonable for quality control departments of manufacturing plants to use Shewhart’s cards and methods of statistical management of technological processes for assessment of state of the latter.
Zh. Mikrobiol. (Moscow), 2009, No. 6, P. 70—75