Anhui University of Finance and Economics, Bengbu, Anhui, China.
University of Waterloo, Waterloo, ON, Canada.
Front Public Health. 2023 Mar 8;11:1103555. doi: 10.3389/fpubh.2023.1103555. eCollection 2023.
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.
良好生产规范（GMP）是世界各国政府评判现代制药公司生产流程和产品安全标准的黄金标准之一。然而，在所有国家，都很难获得关于 GMP 检查结果的真实数据，因此相关研究无法开展。我们利用一次难得的机会获取了中国的现场 GMP 检查结果，从而能够对公司特征和风险管理如何影响某些制药公司的 GMP 检查结果展开实证分析。本研究采用了两阶段最小二乘法（2SLS）回归。我们的四项主要发现如下。第一，与中国国有企业相比，外资商业企业和私营企业的标准更高。第二，那些主要资金来源不依赖银行贷款的企业，其 GMP 检查结果往往更好。第三，固定资产较高的企业往往会获得更好的 GMP 检查结果。第四，质量授权人员在公司工作的时间越长，企业预期的 GMP 检查结果就越好。这些发现为中国和其他符合 GMP 标准的国家的检查和生产改进提供了参考。
