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
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
Complete thread:
- reporting dates in qa declarationkrishnamurthy ca 2007-05-17 11:40
- reporting dates in qa declaration drdds 2007-06-04 10:30