药品质量抽验分析报告的撰写建议

目的:为药品质量抽验分析报告的撰写提供参考。方法:对我国药品质量分析报告的现状与问题进行分析和总结,对药品质量抽验分析报告的撰写原则、格式和应涵盖的内容提出思路和建议。结果与结论:药品质量抽验分析报告的撰写应以年度药品抽验工作计划为核心,以各级各类监督抽验数据为基础,按概述和分述两部分,分别对地区药品质量抽验工作开展情况、稽查打假工作情况、药品不合格检测项目分析等内容进行评述,方可促进药品质量抽验分析报告与监管工作的良性互动。

Discussion on the Writing of Quality Analysis Report of Drug Sampling and Testing

OBJECTIVE： To provide reference for the writing of quality＇analysis report of drug sampling and testing. METH- ODS： The problems and situation of drug quality analysis report were summarized and analyzed. The idea and suggestions were pro- posed for the principles of writing, format and content of drug quality analysis report. RESULTS ＆ CONCLUSIONS： The drafting of drug quality analysis report focus on annual drug sampling plan on the basis of supervising and sampling data at different levels. The development of drug sampling, inspecting and cracking down on fake products and items of unqualified drug test are comment- ed in fields of summary and described, which promote positive interaction between quality analysis report of drug sampling and test- ing and supervision.