THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE
The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the su...
| Main Authors: | , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/242 |
| _version_ | 1797875005525065728 |
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| author | S. A. Zaitsev A. V. Basevich A. O. Hrustaleva |
| author_facet | S. A. Zaitsev A. V. Basevich A. O. Hrustaleva |
| author_sort | S. A. Zaitsev |
| collection | DOAJ |
| description | The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the substance non-pharmacopoeia quality, to minimize the consumption of cost, time and manpower resources for qualifying manufacturers, to form a reasonable list of manufacturers to audit their production sites. |
| first_indexed | 2024-04-10T01:40:58Z |
| format | Article |
| id | doaj.art-0d4dc9b71e6448f485404b6b1a3a46b3 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2024-04-10T01:40:58Z |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-0d4dc9b71e6448f485404b6b1a3a46b32023-03-13T09:13:57ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0101208214242THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURES. A. Zaitsev0A. V. Basevich1A. O. Hrustaleva2ЗАО «БИОКАД»ГБОУ ВПО «Санкт-Петербургская государственная химико-фармацевтическая академия» Минздрава РоссииЗАО «БИОКАД»The paper demonstrates application of the newly developed procedure for pre-selection of suppliers of active pharmaceutical ingredient to manufacture of drugs using the tools of risk analysis. The procedure allows to organize the process of selecting suppliers, to reduce the risk of acquiring the substance non-pharmacopoeia quality, to minimize the consumption of cost, time and manpower resources for qualifying manufacturers, to form a reasonable list of manufacturers to audit their production sites.https://www.pharmjournal.ru/jour/article/view/242анализ поставщиковкритерий выборауровни критериев выборааудит производственных площадокпроцедура квалификации производителей субстанции |
| spellingShingle | S. A. Zaitsev A. V. Basevich A. O. Hrustaleva THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE Разработка и регистрация лекарственных средств анализ поставщиков критерий выбора уровни критериев выбора аудит производственных площадок процедура квалификации производителей субстанции |
| title | THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE |
| title_full | THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE |
| title_fullStr | THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE |
| title_full_unstemmed | THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE |
| title_short | THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE |
| title_sort | procedure of active pharmaceutical ingredient suppliers preliminary choice for medicine manufacture |
| topic | анализ поставщиков критерий выбора уровни критериев выбора аудит производственных площадок процедура квалификации производителей субстанции |
| url | https://www.pharmjournal.ru/jour/article/view/242 |
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