sambasivarao
☆    

2010-10-12 12:14
(5732 d 01:53 ago)

Posting: # 6036
Views: 4,701
 

 Usage of method SOP [Bioanalytics]

Can I use Mass parameters otherthan mentioned in the SOP to get sufficient intensity without revising the existing SOP by filling Memo to file.
Jaime_R
★★  

Barcelona,
2010-10-12 15:42
(5731 d 22:25 ago)

@ sambasivarao
Posting: # 6037
Views: 3,875
 

 Revalidation for lower LLOQ

Hi Sambasiva!

First see here.

❝ Can I use Mass parameters other than mentioned in the SOP to get sufficient intensity without revising the existing SOP by filling Memo to file.


Do I get you right - you have a validated method (given LLOQ covered by an SOP) and found out that you need better sensitivity for 'real world' samples? Even if you could achieve this by tuning the instrument, you would need partial revalidation for the lower LLOQ.

Regards, Jaime
sambasivarao
☆    

2010-10-12 16:05
(5731 d 22:02 ago)

@ Jaime_R
Posting: # 6040
Views: 3,747
 

 Revalidation for lower LLOQ

Hi Jaime
Thanks for your reply but my question is not that

I have a validated method for a molecule for the range 10 to 1000 ng/mL. Initiated study analysis based on the existing Method SOP, found less response (not sufficient to continue study) so we have tuned the molecule again and found that there are some changes in the MRM parameters.
now in this case, can i proceed with existing Method SOP without revising by making memo to file for changes in the project.


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! [Jaime]
chidambarajoshi
★    

Hyderabad-INDIA,
2010-10-16 10:55
(5728 d 03:12 ago)

@ sambasivarao
Posting: # 6055
Views: 3,680
 

 Revalidation for lower LLOQ

Dear Samsiva,
IMHO no...! As the method SOP is alrady approved and one can't deviate the approved SOP. Better you revise the method SOP capture the change and use
Rgds
Joshi

Best Regards
Joshi
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