Bioequivalence and Bioavailability Forum • reporting dates in qa declaration

krishnamurthy ca
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2007-05-17 13:40
(6187 d 19:46 ago)

Posting: # 732
Views: 4,694

reporting dates in qa declaration [GxP / QC / QA]

Dear all
In BA/BE studies, the QA check of different procedures such as review of raw data, chromatograms etc last over a period of a week or 10 days. In the QA Statement, the start and end dates of the review of each phase are reflected. During this period, more than one observation may be sent to the Doer department for a particular phase (Eg. Chromatogram checking). In that case, what would be the reporting date in the QA Statement for that particular phase?
rgs
Krishnamurthy

drdds ● 2007-06-04 12:30 (6169 d 20:56 ago) @ krishnamurthy ca Posting: # 776 Views: 3,567	reporting dates in qa declaration Post reply
	Dear Krishnamurthy, As far as i Know a good QA mentions dates specific for the perticular part of data review in the report. For eg- if they are reviewing raw data for the clinical study, they will menion from date x- to date Y, reviewed raw data of clinic. and for PK analysis, from date A to date B data reviewed. SO there no question of overlapping.. Regards DDS