INTRODUCTION 3
CHAPTER 1: FEATURES OF GMP STANDARDS IN THE MODERN PHARMACEUTICAL INDUSTRY 5
1-1 History and background of the implementation of good production practice standards in the pharmaceutical industry 5
1-2 Review of Russian GMP standards 9
CHAPTER 2: FEATURES OF THE IMPLEMENTATION OF GMP STANDARDS IN THE PHARMACEUTICAL INDUSTRY 12
2-1 Comparative analysis of GMP and ISO standards and their implementation 12
2-2 Methodological aspects of developing a quality review of medicinal products in accordance with GMP requirements 15
CHAPTER 3: FEATURES OF THE IMPLEMENTATION OF GMP STANDARDS IN THE PHARMACEUTICAL INDUSTRY 23
3.1 Some aspects of conducting GMP inspections in Russia 23
3.2 Analysis of the main violations detected during the inspection 26
CONCLUSION 29
REFERENCES 30
The purpose of this study is to analyze the GMP rules in pharmaceutical industry.
Tasks:
1. Research of history and background of the implementation of good production practice standards in the pharmaceutical industry;
2. Make review of Russian GMP standards;
3. Present the comparative analysis of GMP and ISO standards and their implementation;
4. Consider methodological aspects of developing a quality review of medicinal products in accordance with GMP requirements;
5. Research some aspects of conducting GMP inspections in Russia;
6. Make the analysis of the main violations detected during the inspection.
The objects of the study are GMP rules.
The research methodology is the collection of information through the study of scientific literature.
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GMP rules in pharmaceutical production #1509072
Артикул: 1509072
- Предмет: Pharm chemistry
- Уникальность: 85% (Антиплагиат.ВУЗ)
- Разместил(-а): 103 Егор в 2021 году
- Количество страниц: 33
- Формат файла: docx
1 990p.
1. The order of the Ministry of Industry and Trade of Russia from 14.06.2013 No. 916 «On approval of the Rules of Good Manufacturing Practice». Available at: http://docs.cntd.ru/document/499029882
2. Bioquell, “Good manufacturing practice is essential to any company in the pharmaceutical industry,” 2018. [Online]. Available: http://healthcare.bioquell.com/en-ie/life-sciences/life-science-resources/risk-mitigation/good-manufacturing-practice-essential-any-company-pharmaceutical-industry
3. Calabrese R., Trotter M. and Luc T. Fu, Looking for a Common Ground for ISO 9001 and Good Manufacturing Practices, URL: https://www.qualitydigest.com/mar08/articles/5_article.shtml
4. Carroll C. BG5107 – Quality Management Systems for Biotechnology:, Galway: NUI Galway, 2018.
5. Chaudhari, V. K., Yadav, V., Verma, P K., & Singh, A. K. (2014). A review on good manufacturing practice (GMP) for medicinal products. PharmaTutor, 2(9), 8-19.
6. Ershova E.V. Approaches to the implementation of an integrated management system in the pharmaceutical industry, International Journal for Quality Research, - № 9(3), - 2015, - p. 527-546.
7. Gurina, N. S., Mushkina, O. V., & Makarenko, S. V. (2015). Food and Drug Administration USA. Proceedings of BSU, 10(1), 22-42.
8. Jain, S. K., & Jain, R. K. (2017). Evolution of GMP in pharmaceutical industry. Research Journal of Pharmacy and Technology, 10(2), 601-606. https://doi.org/10.5958/0974-360X.2017.00118.4
9. Patel, K. T., & Chotai, N. P. (2008). Pharmaceutical GMP: past, present, and future - a review. Die Pharmazie - An International Journal of Pharmaceutical Sciences, 63(4), 251-255. https://doi.org/10.1691/ph.2008.7319
10. Poly M., Petroni D., Pardini S., Salvadori P.A. and Menichetti L, Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre, Accred Qual Assur, - №17, - 2012, - p. 341-348.
11. Prieto Y.O. Good Laboratory Practices and the ISO 9001:2000 standards, Biotecnologia Aplicada, - № 25, - 2018, - p. 258-261.
12. Safiullina R.A., Garmonov S.Yu., Goryunova S.M. Approaches to periodic quality reviewing of the drugs on GMP rules. Kazan Technological University’s bulletin. 2012, No. 9, V. 15. pp. 252-255.
13. Shukla, A., Vishnoi, G., & Das, D. R. (2016). Current good manufacturing guidelines for medicinal product. Journal of Drug Delivery and Therapeutics, 6(2), 57-61. https://doi.org/10.22270/jddt.v6i2.1201
1. The order of the Ministry of Industry and Trade of Russia from 14.06.2013 No. 916 «On approval of the Rules of Good Manufacturing Practice». Available at: http://docs.cntd.ru/document/499029882
2. Bioquell, “Good manufacturing practice is essential to any company in the pharmaceutical industry,” 2018. [Online]. Available: http://healthcare.bioquell.com/en-ie/life-sciences/life-science-resources/risk-mitigation/good-manufacturing-practice-essential-any-company-pharmaceutical-industry
3. Calabrese R., Trotter M. and Luc T. Fu, Looking for a Common Ground for ISO 9001 and Good Manufacturing Practices, URL: https://www.qualitydigest.com/mar08/articles/5_article.shtml
4. Carroll C. BG5107 – Quality Management Systems for Biotechnology:, Galway: NUI Galway, 2018.
5. Chaudhari, V. K., Yadav, V., Verma, P K., & Singh, A. K. (2014). A review on good manufacturing practice (GMP) for medicinal products. PharmaTutor, 2(9), 8-19.
6. Ershova E.V. Approaches to the implementation of an integrated management system in the pharmaceutical industry, International Journal for Quality Research, - № 9(3), - 2015, - p. 527-546.
7. Gurina, N. S., Mushkina, O. V., & Makarenko, S. V. (2015). Food and Drug Administration USA. Proceedings of BSU, 10(1), 22-42.
8. Jain, S. K., & Jain, R. K. (2017). Evolution of GMP in pharmaceutical industry. Research Journal of Pharmacy and Technology, 10(2), 601-606. https://doi.org/10.5958/0974-360X.2017.00118.4
9. Patel, K. T., & Chotai, N. P. (2008). Pharmaceutical GMP: past, present, and future - a review. Die Pharmazie - An International Journal of Pharmaceutical Sciences, 63(4), 251-255. https://doi.org/10.1691/ph.2008.7319
10. Poly M., Petroni D., Pardini S., Salvadori P.A. and Menichetti L, Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre, Accred Qual Assur, - №17, - 2012, - p. 341-348.
11. Prieto Y.O. Good Laboratory Practices and the ISO 9001:2000 standards, Biotecnologia Aplicada, - № 25, - 2018, - p. 258-261.
12. Safiullina R.A., Garmonov S.Yu., Goryunova S.M. Approaches to periodic quality reviewing of the drugs on GMP rules. Kazan Technological University’s bulletin. 2012, No. 9, V. 15. pp. 252-255.
13. Shukla, A., Vishnoi, G., & Das, D. R. (2016). Current good manufacturing guidelines for medicinal product. Journal of Drug Delivery and Therapeutics, 6(2), 57-61. https://doi.org/10.22270/jddt.v6i2.1201
2. Bioquell, “Good manufacturing practice is essential to any company in the pharmaceutical industry,” 2018. [Online]. Available: http://healthcare.bioquell.com/en-ie/life-sciences/life-science-resources/risk-mitigation/good-manufacturing-practice-essential-any-company-pharmaceutical-industry
3. Calabrese R., Trotter M. and Luc T. Fu, Looking for a Common Ground for ISO 9001 and Good Manufacturing Practices, URL: https://www.qualitydigest.com/mar08/articles/5_article.shtml
4. Carroll C. BG5107 – Quality Management Systems for Biotechnology:, Galway: NUI Galway, 2018.
5. Chaudhari, V. K., Yadav, V., Verma, P K., & Singh, A. K. (2014). A review on good manufacturing practice (GMP) for medicinal products. PharmaTutor, 2(9), 8-19.
6. Ershova E.V. Approaches to the implementation of an integrated management system in the pharmaceutical industry, International Journal for Quality Research, - № 9(3), - 2015, - p. 527-546.
7. Gurina, N. S., Mushkina, O. V., & Makarenko, S. V. (2015). Food and Drug Administration USA. Proceedings of BSU, 10(1), 22-42.
8. Jain, S. K., & Jain, R. K. (2017). Evolution of GMP in pharmaceutical industry. Research Journal of Pharmacy and Technology, 10(2), 601-606. https://doi.org/10.5958/0974-360X.2017.00118.4
9. Patel, K. T., & Chotai, N. P. (2008). Pharmaceutical GMP: past, present, and future - a review. Die Pharmazie - An International Journal of Pharmaceutical Sciences, 63(4), 251-255. https://doi.org/10.1691/ph.2008.7319
10. Poly M., Petroni D., Pardini S., Salvadori P.A. and Menichetti L, Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre, Accred Qual Assur, - №17, - 2012, - p. 341-348.
11. Prieto Y.O. Good Laboratory Practices and the ISO 9001:2000 standards, Biotecnologia Aplicada, - № 25, - 2018, - p. 258-261.
12. Safiullina R.A., Garmonov S.Yu., Goryunova S.M. Approaches to periodic quality reviewing of the drugs on GMP rules. Kazan Technological University’s bulletin. 2012, No. 9, V. 15. pp. 252-255.
13. Shukla, A., Vishnoi, G., & Das, D. R. (2016). Current good manufacturing guidelines for medicinal product. Journal of Drug Delivery and Therapeutics, 6(2), 57-61. https://doi.org/10.22270/jddt.v6i2.1201
1. The order of the Ministry of Industry and Trade of Russia from 14.06.2013 No. 916 «On approval of the Rules of Good Manufacturing Practice». Available at: http://docs.cntd.ru/document/499029882
2. Bioquell, “Good manufacturing practice is essential to any company in the pharmaceutical industry,” 2018. [Online]. Available: http://healthcare.bioquell.com/en-ie/life-sciences/life-science-resources/risk-mitigation/good-manufacturing-practice-essential-any-company-pharmaceutical-industry
3. Calabrese R., Trotter M. and Luc T. Fu, Looking for a Common Ground for ISO 9001 and Good Manufacturing Practices, URL: https://www.qualitydigest.com/mar08/articles/5_article.shtml
4. Carroll C. BG5107 – Quality Management Systems for Biotechnology:, Galway: NUI Galway, 2018.
5. Chaudhari, V. K., Yadav, V., Verma, P K., & Singh, A. K. (2014). A review on good manufacturing practice (GMP) for medicinal products. PharmaTutor, 2(9), 8-19.
6. Ershova E.V. Approaches to the implementation of an integrated management system in the pharmaceutical industry, International Journal for Quality Research, - № 9(3), - 2015, - p. 527-546.
7. Gurina, N. S., Mushkina, O. V., & Makarenko, S. V. (2015). Food and Drug Administration USA. Proceedings of BSU, 10(1), 22-42.
8. Jain, S. K., & Jain, R. K. (2017). Evolution of GMP in pharmaceutical industry. Research Journal of Pharmacy and Technology, 10(2), 601-606. https://doi.org/10.5958/0974-360X.2017.00118.4
9. Patel, K. T., & Chotai, N. P. (2008). Pharmaceutical GMP: past, present, and future - a review. Die Pharmazie - An International Journal of Pharmaceutical Sciences, 63(4), 251-255. https://doi.org/10.1691/ph.2008.7319
10. Poly M., Petroni D., Pardini S., Salvadori P.A. and Menichetti L, Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre, Accred Qual Assur, - №17, - 2012, - p. 341-348.
11. Prieto Y.O. Good Laboratory Practices and the ISO 9001:2000 standards, Biotecnologia Aplicada, - № 25, - 2018, - p. 258-261.
12. Safiullina R.A., Garmonov S.Yu., Goryunova S.M. Approaches to periodic quality reviewing of the drugs on GMP rules. Kazan Technological University’s bulletin. 2012, No. 9, V. 15. pp. 252-255.
13. Shukla, A., Vishnoi, G., & Das, D. R. (2016). Current good manufacturing guidelines for medicinal product. Journal of Drug Delivery and Therapeutics, 6(2), 57-61. https://doi.org/10.22270/jddt.v6i2.1201
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| Тема: | GMP rules in pharmaceutical production |
| Артикул: | 1509072 |
| Дата написания: | 26.12.2021 |
| Тип работы: | Курсовая работа |
| Предмет: | Pharm chemistry |
| Оригинальность: | Антиплагиат.ВУЗ — 85% |
| Количество страниц: | 33 |
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