药品检验报告书底稿及检验原始记录书写质量分析

Analysis of Writing Quality of Manuscript of Drug Control Report and Original Testing Record

目的探讨提高药品检验所检验报告书底稿及检验原始记录书写质量的措施,保证出具检验报告的准确性。方法对毕节地区药品检验所近7年的检验报告书底稿及检验原始记录进行复审,对发现的问题进行分类统计并分析讨论。结果在6128份检验报告书底稿及检验原始记录的复审中,有1471份不合格,不合格率为24.00%。结论应完善检验报告书底稿及检验原始记录书写规范细则,建立检验报告书底稿及检验原始记录书写质量监管体系和培训、学习、考评制度,以提高药品检验所检验报告书底稿及检验原始记录书写质量。

Objective This paper is to probe into the measure of improving the writing quality of the manuscript of drug control report and the original testing record of the institute for drug control, in order to guarantee the veracity of the drug control report. Methods A classified statistics shall be carried out on the manuscript of drug control report of the last 7 years and problems occurred in the review process of those manuscripts of drug control report, and a consequent analysis and discussion shall be followed. Results There were altogether 1471 unqualified reports among the 6128 manuscripts of drug control reports and reviews, up to 24.00% of the total. Conclusion A standard on improving the writing quality of manuscript of drug control report and the original testing record should be set up and a further training and examination system of the standard should be applied to improve the quality of drug control report manuscript and the original testing record.