Academic Journal

Characteristics, risk management and GMP standards of pharmaceutical companies in China

التفاصيل البيبلوغرافية
العنوان: Characteristics, risk management and GMP standards of pharmaceutical companies in China
المؤلفون: Hong Chen, Lijian Qin, Cong Jiang, Mingshuai Qin, Yanming Sun, Jingjing Luo
المصدر: Frontiers in Public Health, Vol 11 (2023)
بيانات النشر: Frontiers Media S.A., 2023.
سنة النشر: 2023
المجموعة: LCC:Public aspects of medicine
مصطلحات موضوعية: pharmaceutical company characteristics, risk management, GMP, pharmaceutical company supervision, China, Public aspects of medicine, RA1-1270
الوصف: The Good Manufacturing Practice (GMP) is one of the gold standards by which governments worldwide judge modern pharmaceutical companies' production processes and product-safety standards. However, in all the nations, it is difficult to obtain real data about GMP inspection results, so conducting the related research is impossible. Taking advantage of a rare chance to obtain the on-site GMP inspection results in China, we have been able to initiate an empirical analysis of how company characteristics and risk management affect the GMP inspection results of certain pharmaceutical companies. The 2SLS method regression was employed in this study. Our four main findings are as follows. First, compared with Chinese state-owned companies, foreign commercial and private enterprises are held to higher standards. Second, the GMP inspection results tend to be better for those enterprises whose main sources of capital are not dependent on bank loans. Third, enterprises with higher fixed assets tend to receive the better GMP inspection results. Fourth, the longer the quality authorized staff has worked in a company, the better the GMP inspection results expected of that enterprise. These findings offer insights into inspections and production improvements in China and other GMP-compliant countries.
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 2296-2565
Relation: https://www.frontiersin.org/articles/10.3389/fpubh.2023.1103555/full; https://doaj.org/toc/2296-2565
DOI: 10.3389/fpubh.2023.1103555
URL الوصول: https://doaj.org/article/56ae3d82867841fdae5e57e8b283ca26
رقم الانضمام: edsdoj.56ae3d82867841fdae5e57e8b283ca26
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:22962565
DOI:10.3389/fpubh.2023.1103555