Bioequivalence and Bioavailability Forum

VP ☆ 2010-01-06 12:38 (6019 d 12:40 ago) Posting: # 4564 Views: 3,128	Validation and Subject sample analysis [Bioanalytics] Post reply
	Dear all We have completed method validation for one drug. QA has done inprocess audit of validation but we did not submit the data after completion of validation to to QA for retrospective audit. Can we start subject sample analysis (for same drug) before QA audit. if yes/no any referance is there for same? Is it necessary to file any note to file or SOP deviation for same? Thanks & regards VP

Debbie
★

India,
2010-01-06 18:01
(6019 d 07:17 ago)

@ VP
Posting: # 4566
Views: 2,415

Validation and Subject sample analysis

Post reply

Dear VP,

i think its better practice to start the subject sample analysis after the QA review of the method validation.

If the study is for european region, i may caution you, as we had an experience of getting the observation for the same issue from an european regulatory authority.

regarding the reference, it may be a better GLP practice of having full confidence and certification (from your independent QA) of your method performance before starting the subject sample analysis.

for the documentation, all depends on what your SOP says about your procedures/practices.

Regards,

Debbie

Validation and Subject sample analysis [Bioanalytics]

Validation and Subject sample analysis