Issues and Suggestions of Pharmaceutical Contract Manufacturing Inspection in Guangdong Province under the New Situation of Regulation
Objective:To explore the strategy in improving the quality management level of holders of pharmaceutical contract manufacturing(B certificate)under the new regulatory requirements.Methods:By sorting out the found defects in the inspection of B certificate of pharmaceutical contract manufacturing in the previous year,the essential reasons for the defects in Bcertificate enterprises were analyzed,and feasible suggestions were put forward in combination with the new regulations.Results and Conclusion:After combing 136 defects,it was found that the problems of the holders mainly about three aspects(personnel and institution,quality assurance system,documents and records)were summarized into missing responsibility,communication loss and execution loss.It is suggested that the B-certificate holders should clarify the responsibilities of both parties,improve the communication system,link up the implementation procedures,and implement the main responsibility of the whole life cycle of drug.
drug regulationpharmaceutical contract manufacturingcore issuesinspectionanalytical suggestions
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