湖北原料药GMP认证中发明的主要缺点及建议-中国

2020-04-06 05:04:02 - admin

  1264

  ·质量办理·

  湖北省原料药GMP认证中发明的主要缺点及建议

  *

  孙煜,吕思伊 ,魏曼 (湖北省食品药品监督办理局技巧审评查对中间,武汉 430071)

  摘要 目标:

  为单方面了解原料药GMP认证相干规范,提高花费企业对原料药花费规范的看法和检查员的

  检查水平。方法:对2016年至2017年湖北省原料药现场检查中主要缺点停止统计剖析,对GMP认证中主

  要缺点项目停止分类总结。结果与结论:经过特点后果,联合原料药产品的自身特色,建议增强各岗亭

  操作人员培训,落实培训后果;公道设计厂房,增强硬件系统的改革;严厉把关物料,做好溶剂收受接管工

  作;重视细节,有针对性做好确认与验证任务;文件办理系统化,记录填写规范化;引入风险办理,贯

  彻履行花费全过程办理;重视变卦和偏向办理,提高质量看法;建立职业化检查员部队。

  关键词: 原料药;GMP认证;主要缺点项目

  R95 A 1002-7777(2018)09-1264-07

  中图分类号: 文献标识码: 文章编号:

  doi:10.16153/j.1002-7777.2018.09.018

  Main Defects and Suggestions on GMP Certification of Active Pharmaceutical

  Ingredients in Hubei Province

  *

  Sun Yu, Lv Siyi , Wei Man (Center for Evaluation and Inspection, Hubei Food and Drug Administration, Wuhan

  430071, China)

  Abstract Objective: To fully understand the relevant standards for good manufacturing practice (GMP)

  certification of active pharmaceutical ingredients (API) in order to improve the understanding of the production

  standards of API of enterprises and the level of inspectors. Methods: The main defects of on-site inspection of

  API of Hubei Province from 2016 to 2017 were statistically analyzed, and the main defects in GMP certification

  were classified and summarized. Results and Conclusion: According to the common problems combined with the

  characteristics of API, it is recommended to strengthen the training of operators in each position and to implement

  the training results; to rationally design the workshop and to strengthen the transformation of the hardware

  system; to strictly control the materials and do a good job of solvent recovery; to pay attention to details and to do

  a good job of targeted confirmation and verification; to systemize the document management and to standardize

  the record; to introduce risk management and to implement the whole production process management; to pay

  attention to change and deviation management

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