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


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Abstract

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.

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ОЦЕНКА СТАБИЛЬНОСТИ ТЕХНОЛОГИЧЕСКОГО ПРОЦЕССА С ПОМОЩЬЮ КОНТРОЛЬНЫХ КАРТ НА ПРИМЕРЕ АНАЛИЗА ИНФОРМАЦИИ ОБ ИММУНОГЕННОЙ АКТИВНОСТИ КОКЛЮШНОГО КОМПОНЕНТА АКДС-ВАКЦИНЫ
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About the authors

I. A Alekseeva

Tarasevich State Institute for Standardization and Control of Medicinal Immunobiologic Preparations, Moscow, Russia

R. P Chuprinina

Tarasevich State Institute for Standardization and Control of Medicinal Immunobiologic Preparations, Moscow, Russia

D. S Davydov

Tarasevich State Institute for Standardization and Control of Medicinal Immunobiologic Preparations, Moscow, Russia

References

  1. ГОСТ Р 50779.42-99 (ИСО 8258-91). Статистические методы. Контрольные карты Shewhart W. Госстандарт России. М., 1999.
  2. Комитет экспертов ВОЗ по стандартизации биологических препаратов. Серия техниче- ских докладов 800 (40 доклад). ВОЗ, Женева, 1992.
  3. Shewhart W. Statistical Method from the viewpoint of quality control. N.Y., Dover Publ. Inc., 1939.

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Copyright (c) 2009 Alekseeva I.A., Chuprinina R.P., Davydov D.S.

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