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 |
| Summary: | 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. |
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| ISSN: | 2305-2066 2658-5049 |