CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY
The scope of certification of the quality management system is extended to research activities at the St. Petersburg Chemical and Pharmaceutical Academy. This allowed to to create more universal and effective system of organizing educational and research activities at the Academy when the integratio...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/568 |
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| _version_ | 1849395900248489984 |
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| author | I. A. Narkevich E. V. Flisyuk A. V. Moskvin L. V. Shigarova D. Y. Ivkin A. S. Ivkina |
| author_facet | I. A. Narkevich E. V. Flisyuk A. V. Moskvin L. V. Shigarova D. Y. Ivkin A. S. Ivkina |
| author_sort | I. A. Narkevich |
| collection | DOAJ |
| description | The scope of certification of the quality management system is extended to research activities at the St. Petersburg Chemical and Pharmaceutical Academy. This allowed to to create more universal and effective system of organizing educational and research activities at the Academy when the integration of the process model mentioned and existing in the academy occurred. Based on this experience, management plans to confirm the compliance of activities of one of the structural units with GLP requirements. The authors demonstrated the feasibility of implementing a quality management system in accordance with the ISO 9001 standards as a strategic platform for preparing for the certification of preclinical research for compliance with the requirements of good laboratory practice (GLP). |
| format | Article |
| id | doaj-art-ebea6ff2a44e4a38848dad6663329365 |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-ebea6ff2a44e4a38848dad66633293652025-08-20T03:39:28ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0101226230568CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGYI. A. Narkevich0E. V. Flisyuk1A. V. Moskvin2L. V. Shigarova3D. Y. Ivkin4A. S. Ivkina5St. Petersburg Chemical and Pharmaceutical AcademySt. Petersburg Chemical and Pharmaceutical AcademySt. Petersburg Chemical and Pharmaceutical AcademySt. Petersburg Chemical and Pharmaceutical AcademySt. Petersburg Chemical and Pharmaceutical AcademySt. Petersburg Chemical and Pharmaceutical AcademyThe scope of certification of the quality management system is extended to research activities at the St. Petersburg Chemical and Pharmaceutical Academy. This allowed to to create more universal and effective system of organizing educational and research activities at the Academy when the integration of the process model mentioned and existing in the academy occurred. Based on this experience, management plans to confirm the compliance of activities of one of the structural units with GLP requirements. The authors demonstrated the feasibility of implementing a quality management system in accordance with the ISO 9001 standards as a strategic platform for preparing for the certification of preclinical research for compliance with the requirements of good laboratory practice (GLP).https://www.pharmjournal.ru/jour/article/view/568quality management systemprocess modelgood laboratory practiceaudit |
| spellingShingle | I. A. Narkevich E. V. Flisyuk A. V. Moskvin L. V. Shigarova D. Y. Ivkin A. S. Ivkina CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY Разработка и регистрация лекарственных средств quality management system process model good laboratory practice audit |
| title | CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY |
| title_full | CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY |
| title_fullStr | CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY |
| title_full_unstemmed | CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY |
| title_short | CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY |
| title_sort | certification for the conformity of iso 9001 equirements as a first phase of implementation of good laboratory practice in the center of experimental pharmacology |
| topic | quality management system process model good laboratory practice audit |
| url | https://www.pharmjournal.ru/jour/article/view/568 |
| work_keys_str_mv | AT ianarkevich certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology AT evflisyuk certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology AT avmoskvin certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology AT lvshigarova certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology AT dyivkin certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology AT asivkina certificationfortheconformityofiso9001equirementsasafirstphaseofimplementationofgoodlaboratorypracticeinthecenterofexperimentalpharmacology |