PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET
Background. The relevance of the proposed methodology for recalling substandard products from the pharmaceutical market is determined by the requirements of GOST R ISO 9001-2015 and GOST R ISO 10393-2014. The aim of the work is to choose methods for identifying poor-quality products in the pharmaceu...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Penza State University Publishing House
2023-09-01
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| Series: | Измерение, мониторинг, управление, контроль |
| Subjects: |
| _version_ | 1797733594043514880 |
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| author | Elena V. Kiryushkina Inna A. Kostrikina |
| author_facet | Elena V. Kiryushkina Inna A. Kostrikina |
| author_sort | Elena V. Kiryushkina |
| collection | DOAJ |
| description | Background. The relevance of the proposed methodology for recalling substandard products from the pharmaceutical market is determined by the requirements of GOST R ISO 9001-2015 and GOST R ISO 10393-2014. The aim of the work is to choose methods for identifying poor-quality products in the pharmaceutical market and develop a procedure for recalling them. Materials and methods. To solve this problem, the method of the matrix of consequences and probabilities was used according to the indicators "risk probability" and "risk impact level". Results. In the course of the work, a methodology was proposed for recalling poor-quality products from the pharmaceutical market, which is an integral part of the quality management system for pharmaceutical products. Conclusions. The positive results of the work open up the prospect of effective application of the methodology as a basis for organizing the recall management process in any pharmaceutical industry or for improving an existing process. |
| first_indexed | 2024-03-12T12:31:19Z |
| format | Article |
| id | doaj.art-182a4fb12a3e46849bb8774d1123144b |
| institution | Directory Open Access Journal |
| issn | 2307-5538 |
| language | English |
| last_indexed | 2024-03-12T12:31:19Z |
| publishDate | 2023-09-01 |
| publisher | Penza State University Publishing House |
| record_format | Article |
| series | Измерение, мониторинг, управление, контроль |
| spelling | doaj.art-182a4fb12a3e46849bb8774d1123144b2023-08-29T08:07:15ZengPenza State University Publishing HouseИзмерение, мониторинг, управление, контроль2307-55382023-09-01210.21685/2307-5538-2023-2-9PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET Elena V. Kiryushkina0Inna A. Kostrikina1Penza State UniversityScientific Research Institute of Electronic and Mechanical DevicesBackground. The relevance of the proposed methodology for recalling substandard products from the pharmaceutical market is determined by the requirements of GOST R ISO 9001-2015 and GOST R ISO 10393-2014. The aim of the work is to choose methods for identifying poor-quality products in the pharmaceutical market and develop a procedure for recalling them. Materials and methods. To solve this problem, the method of the matrix of consequences and probabilities was used according to the indicators "risk probability" and "risk impact level". Results. In the course of the work, a methodology was proposed for recalling poor-quality products from the pharmaceutical market, which is an integral part of the quality management system for pharmaceutical products. Conclusions. The positive results of the work open up the prospect of effective application of the methodology as a basis for organizing the recall management process in any pharmaceutical industry or for improving an existing process. recallpharmaceutical marketsubstandard productsrecall effectivenessrecall coordinatorrecall strategyrecall category |
| spellingShingle | Elena V. Kiryushkina Inna A. Kostrikina PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET Измерение, мониторинг, управление, контроль recall pharmaceutical market substandard products recall effectiveness recall coordinator recall strategy recall category |
| title | PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET |
| title_full | PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET |
| title_fullStr | PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET |
| title_full_unstemmed | PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET |
| title_short | PRODUCT REVIEW METHODOLOGY FROM THE PHARMACEUTICAL MARKET |
| title_sort | product review methodology from the pharmaceutical market |
| topic | recall pharmaceutical market substandard products recall effectiveness recall coordinator recall strategy recall category |
| work_keys_str_mv | AT elenavkiryushkina productreviewmethodologyfromthepharmaceuticalmarket AT innaakostrikina productreviewmethodologyfromthepharmaceuticalmarket |