Sample Retention Management and Evaluation in Drug Inspection Agencies Based on Process- oriented Adminis- tration Concept
- VernacularTitle:结合流程导向监管理念探讨药品检验机构留样的管理与评价
- Author:
Weimin ZHANG
1
;
Qingquan HUANG
1
;
Baobin HUANG
1
Author Information
1. National Institutes for Food and Drug Control，Beijing 102629，China
- Publication Type:Journal Article
- Keywords:
Process-oriented;
Drug inspection agency;
Sample retention;
Process;
Management
- From:
China Pharmacy
2021;32(3):257-261
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To combine with the concept of process-oriented administration ，and to provide reference for improving the process and measures of the sample retention management and evaluation in drug inspection agencies. METHODS ： From the aspects of organizational management and control measures ，the improvement measures for sample retention management system were investigated. From the aspects of warehouse-in check ，storage management and warehouse-out judgment ，warehouse management and informatization ，the improvement measures for procedures and measures about sample retention management were explored. From the aspects of evaluation content and quality control measures ，the evaluation and continuous improvement of sample retention management were investigated. RESULTS & CONCLUSIONS ：In the aspect of organizational management ，it is necessary to improve management procedures and processes ，determine sample retention objectives and plans ，improve post allocation and management ，and improve safety emergency plans. In the aspect of control measures ，it is necessary to improve the business management measures such as warehouse-in status inspection ，adjust the conditions such as warehouse space allocation ， and improve the intelligent prompt of remaining validity period of samples. The key to the three links of warehouse-in ，storage and warehouse-out are warehouse-in check ，storage space and condition control ，and warehouse-out judgement. The relevant processes and measures can be improved from these aspects. The contents of sample retention management evaluation includes management system，management measures and process ，improvement and evaluation. Plan-Do-Check-Action （PDCA）cycle is a measure to improve the efficiency and quality of sample retention management in drug inspection agencies .
