Study-based 和Process-based inspection 執行的頻率:
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.
過程檢查頻率與過程複雜性、持續時間、執行頻率有關。如果困難的試驗不經常開展，則應安排項目檢查。關於過程檢查的頻率應該在QAU的SOP中反映出來。
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--
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關鍵字: inspections 頻率 檢查
