[Assessment of consistency of technological process using control cards on the example of analysis of information on immunogenic activity of pertussis component of DTP vaccine].
OBJECTIVE
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.


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 componentwas 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.


CONCLUSIONS
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.
Alekseeva
I A
IA
Chuprina
R P
RP
Davydov
D S
DS
D000818:Animals; D001886:Bordetella pertussis / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology* / Q000592:standards*; D051379:Mice; D012426:Russia; D013673:Technology Assessment, Biomedical / Q000379:methods*
D015721:Diphtheria-Tetanus-Pertussis Vaccine