AKV
☆    

2010-05-26 14:14
(5462 d 18:40 ago)

Posting: # 5379
Views: 6,429
 

 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
(5462 d 16:59 ago)

@ AKV
Posting: # 5380
Views: 5,230
 

 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
—
Regards
Ohlbe
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
107 visitors (0 registered, 107 guests [including 6 identified bots]).
Forum time: 08:54 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us.    Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5