Abstract
Based on the survey data from questionnaire of Quality Management of Pharmaceutical Production Enterprises in Anhui Province, this research examines the relationship between the change frequency of production director and GMP inspection results of pharmaceutical manufacturers by adopting OLS model and Logit model. We find that director of manufacturing management plays a direct role in enterprise production management as senior administrator. If director of manufacturing management changes more times, the enterprise’s drug production management will lose persistent stability. As a result, the quality of drug production is affected. Without ability to produce high-quality drugs, the GMP inspection results of pharmaceutical enterprises are poor. Thus, this paper suggests that in daily drug quality supervision, enterprises that frequently change director of manufacturing management should be paid more attention to, and we should increase the frequency of examination, so as to reasonably allocate regulatory resources and carry out targeted supervision.
Highlights
Good Manufacturing Practice (GMP) [1] is an important means to ensure the quality and safety of drug production
The revised version of GMP in 2010. It stipulates that the important person of drug production at least shall include the director of the enterprise, director of manufacturing management, director of quality management and authorized person of quality, among which director of manufacturing management is one of the key personnels in GMP
Which shows that the more director of manufacturing management changes, the worse the GMP inspection results are, indicating that the level of drug quality management is poor
Summary
Good Manufacturing Practice (GMP) [1] is an important means to ensure the quality and safety of drug production. It stipulates that the important person of drug production at least shall include the director of the enterprise, director of manufacturing management, director of quality management and authorized person of quality, among which director of manufacturing management is one of the key personnels in GMP. Article 46 of the measures for supervision and administration of drug production stipulates that if the person in charge of quality or production administration of a drug manufacturer changes, the new one shall, within 15 days after the change, submit his/her resume, education certificate and other relevant information to the food and drug supervision and administration department of the province, autonomous region or municipality where he/she is located for the record [5] Through this measure, the random change of key personnel in drug manufacturing enterprises is restricted to a certain extent
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