Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts
WHO experts attribute the resurgence of whooping cough to the wide use of acellular pertussis vaccines (aPs) as components of combination products. In this regard, WHO encourages countries that have not yet switched to the use of aPs to continue to use whole-cell pertussis vaccines (wPs) for primary...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-12-01
|
| Series: | Биопрепараты: Профилактика, диагностика, лечение |
| Subjects: | |
| Online Access: | https://www.biopreparations.ru/jour/article/view/196 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849242927268626432 |
|---|---|
| author | I. A. Alekseeva O. V. Perelygina E. D. Kolyshkina |
| author_facet | I. A. Alekseeva O. V. Perelygina E. D. Kolyshkina |
| author_sort | I. A. Alekseeva |
| collection | DOAJ |
| description | WHO experts attribute the resurgence of whooping cough to the wide use of acellular pertussis vaccines (aPs) as components of combination products. In this regard, WHO encourages countries that have not yet switched to the use of aPs to continue to use whole-cell pertussis vaccines (wPs) for primary vaccination. The experience of using pertussis vaccines has shown that companies do not always produce highly efficacious products. The use of statistical methods of samples quality control helps to ensure consistency of the technological process, which results in the production of more homogeneous products, and rules out the possibility of producing low-quality products. This paper presents the results of retrospective evaluation of the consistency of the wP (as a pertussis component of the DTP vaccine) production using Shewhart control charts. It was shown that at some points in time during the analyzed period from January 2017 until March 2018 the technological process of the company lacked proper statistical control. This increased the risk of producing non-uniform and defective products. In order to improve the quality and consistency of pertussis component batches, the company’s quality control and quality assurance services should make extensive use of Shewhart charts on a real-time basis. |
| format | Article |
| id | doaj-art-72e92e18d4414355ae2d13e3d4b94bdf |
| institution | Kabale University |
| issn | 2221-996X 2619-1156 |
| language | Russian |
| publishDate | 2018-12-01 |
| publisher | Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Биопрепараты: Профилактика, диагностика, лечение |
| spelling | doaj-art-72e92e18d4414355ae2d13e3d4b94bdf2025-08-20T03:59:39ZrusMinistry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Биопрепараты: Профилактика, диагностика, лечение2221-996X2619-11562018-12-0118424324810.30895/2221-996X-2018-18-4-243-248148Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart ChartsI. A. Alekseeva0O. V. Perelygina1E. D. Kolyshkina2Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsWHO experts attribute the resurgence of whooping cough to the wide use of acellular pertussis vaccines (aPs) as components of combination products. In this regard, WHO encourages countries that have not yet switched to the use of aPs to continue to use whole-cell pertussis vaccines (wPs) for primary vaccination. The experience of using pertussis vaccines has shown that companies do not always produce highly efficacious products. The use of statistical methods of samples quality control helps to ensure consistency of the technological process, which results in the production of more homogeneous products, and rules out the possibility of producing low-quality products. This paper presents the results of retrospective evaluation of the consistency of the wP (as a pertussis component of the DTP vaccine) production using Shewhart control charts. It was shown that at some points in time during the analyzed period from January 2017 until March 2018 the technological process of the company lacked proper statistical control. This increased the risk of producing non-uniform and defective products. In order to improve the quality and consistency of pertussis component batches, the company’s quality control and quality assurance services should make extensive use of Shewhart charts on a real-time basis.https://www.biopreparations.ru/jour/article/view/196whole-cell pertussis vaccineacellular pertussis vaccineassessment of consistency of dtp pertussis component productionshewhart control charts |
| spellingShingle | I. A. Alekseeva O. V. Perelygina E. D. Kolyshkina Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts Биопрепараты: Профилактика, диагностика, лечение whole-cell pertussis vaccine acellular pertussis vaccine assessment of consistency of dtp pertussis component production shewhart control charts |
| title | Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts |
| title_full | Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts |
| title_fullStr | Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts |
| title_full_unstemmed | Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts |
| title_short | Estimation of Consistency of Production of the Pertussis Component of DTP Vaccine in Terms of Immunogenic Activity and Specific Safety Using Shewhart Charts |
| title_sort | estimation of consistency of production of the pertussis component of dtp vaccine in terms of immunogenic activity and specific safety using shewhart charts |
| topic | whole-cell pertussis vaccine acellular pertussis vaccine assessment of consistency of dtp pertussis component production shewhart control charts |
| url | https://www.biopreparations.ru/jour/article/view/196 |
| work_keys_str_mv | AT iaalekseeva estimationofconsistencyofproductionofthepertussiscomponentofdtpvaccineintermsofimmunogenicactivityandspecificsafetyusingshewhartcharts AT ovperelygina estimationofconsistencyofproductionofthepertussiscomponentofdtpvaccineintermsofimmunogenicactivityandspecificsafetyusingshewhartcharts AT edkolyshkina estimationofconsistencyofproductionofthepertussiscomponentofdtpvaccineintermsofimmunogenicactivityandspecificsafetyusingshewhartcharts |