Study-based 和Process-based inspection 执行的频率:
The type of inspection(study-based or process-based) does not only depend on the number of studiesper week / month / year but also from complexity and duration of individualstudies. Once complexity of a study (even lasting for a few hours only) is highand frequency for this type of studies is low (but not justifying routineactivity), study-based inspections should be applied. In order to harmonizeinspection procedure, the GLP Compliance Monitoring Units (Swiss?)consider the following frequencies as a minimal requirement:
- 01 – 10 studies / year =100% study-based inspections
- 11 – 50 studies / year =minimum 20% study-based inspections
- >50 studies / year =minimum 10% study-based inspections
The criteria for use of aprocess-based inspection program should be reflected in the QA program.
过程检查频率与过程复杂性、持续时间、执行频率有关。如果困难的试验不经常开展，则应安排项目检查。关于过程检查的频率应该在QAU的SOP中反映出来。
以上摘自：Swiss Interpretation of theGLP Principles 2013 State: July 18, 2013
http://www.bag.admin.ch/anmeldestelle/12828/12831/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCFfX99g2ym162epYbg2c_JjKbNoKSn6A--
閱讀更多 一點GLP 的文章
關鍵字: inspections 频率 检查
