Guidance_History of revision section in the SOP [Regulatives / Guidelines]

posted by manan  – Ahmedabad, 2011-02-03 07:25 (5623 d 10:06 ago) – Posting: # 6548
Views: 2,141

Dear Karupu

I think there is no need to capture all the version change history. You can include the last superseed in the revised version. But it is better to include a section specifing the reason or the changes you made in the current SOP. You can highlight the changes you had made in the first version, then in the second and so on. this will give a summary of all the changes you have made and the current SOP will reflect the changes made.

I am not sure of any literature specifying this changee.

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
368 visitors (0 registered, 368 guests [including 15 identified bots]).
Forum time: 18:32 CEST (Europe/Vienna)

Don’t compromise yourself.
You are all you’ve got.    Janis Joplin

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