ramya
☆    

2010-03-03 11:07
(5547 d 11:20 ago)

Posting: # 4851
Views: 5,099
 

 review procedure for QA [GxP / QC / QA]

Post reply
Dear All,

I am ramya,working in QA.

i have few doubts about, qa reviewing the pre Method validation.

when the method is developed, should qa has to approve the development for method validation procedure to begin?

or its analyst discretion to decide?

regards,
ramya
 
bharat
☆    

India,
2010-03-17 08:44
(5533 d 13:42 ago)

@ ramya
Posting: # 4924
Views: 4,104
 

 review procedure for QA

Post reply
Dear ramya
Its depends on your Internal SOP.
I will suggest that it will be good if it will approved by QA as it will be authenticated.
There is not such guideline for this
Regards
Bharat

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
 
Dr_Dan
★★  

Germany,
2010-03-17 12:05
(5533 d 10:22 ago)

@ bharat
Posting: # 4927
Views: 4,052
 

 review procedure for QA

Post reply
Dear all
Bharat is right, it depends on your internal SOP. In my opinion the method development does not need to be QA'd. The method SOP has to be QA'd as well as the method validation.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
 
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,669 registered users;
118 visitors (0 registered, 118 guests [including 8 identified bots]).
Forum time: 23:27 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