Bioequivalence and Bioavailability Forum

Dear AKV,

According to the Site Master File template sent by the French GLP inspectors to French test facilities (sorry, I don't know if there is an international recommendation for this), the master schedule should list all studies done at the facility (GLP but also not GLP, in order to get a full evaluation of the workload). For each study it should include:

• the study reference number
  
• the type of study
  
• the identification of the test item
  
• the identification of the test system
  
• the study initiation and completion date
  
• the experimental starting and completion date
  
• the name of the study director
  
• whether it is a GLP study.

❝ Please also guide about who is primarily responsible for generation of

❝ master study schedule for GLP facilities.

GLP § 1.1.2.m: it is the responsibility of the test facility management. Whoever they want to delegate the task to is their decision. GLP § 2.2.1.a: QA should have access to it.

Regards
Ohlbe