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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989100%3A27510%2F23%3A10252782" target="_blank" >RIV/61989100:27510/23:10252782 - isvavai.cz</a>

Result on the web

<a href="https://www.frontiersin.org/articles/10.3389/fpubh.2023.1103555/full" target="_blank" >https://www.frontiersin.org/articles/10.3389/fpubh.2023.1103555/full</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3389/fpubh.2023.1103555" target="_blank" >10.3389/fpubh.2023.1103555</a>

Result language

angličtina

Original language name

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

Original language description

The Good Manufacturing Practice (GMP) is one of the gold standards by which governments worldwide judge modern pharmaceutical companies&apos; 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.

Czech name

—

Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

50200 - Economics and Business

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Frontiers in Public Health

ISSN

2296-2565

e-ISSN

2296-2565

Volume of the periodical

11

Issue of the periodical within the volume

March

Country of publishing house

CH - SWITZERLAND

Number of pages

14

Pages from-to

1103555

UT code for WoS article

000954246800001

EID of the result in the Scopus database

2-s2.0-85150495142