Bioequivalence and Bioavailability Forum

AKV ☆ 2010-05-26 14:14 (5866 d 11:36 ago) Posting: # 5379 Views: 7,737	master study schedule [GxP / QC / QA] Post reply
	Dear All, Kindly requesting you all to guide on the procedure for preparation and maintaning of master study schedule which is a GLP requirement. Please also guide about who is primarily responsible for generation of master study schedule for GLP facilities. Inputs received are highly appreciated, Thanks in advance

Ohlbe
★★★

France,
2010-05-26 15:54
(5866 d 09:55 ago)

@ AKV
Posting: # 5380
Views: 6,275

Master schedule

Post reply

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

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Regards
Ohlbe

master study schedule [GxP / QC / QA]

Master schedule