Page 35 - Introduction QC
P. 35
GMP Training – Introduction to Quality Control (QC) by www.gmpsop.com
Validation protocols and reports
Lab notebooks
Raw data
Chromatograms
Electronic files
Testing summaries and reports
Maintenance and calibration records
Training records
Job descriptions
Employment records
Completing notebooks and sheets
The following list shows some common rules for filling out notebooks and
laboratory worksheets.
Date and sequentially number each page.
Record the standard reference or lot number, and the strength/activity.
Record the sample lot number.
Reference the test method document (e.g. TM-1204 Ver D).
Reference the instrument the test was performed on (e.g. HPLC #24).
Record all observations and measurements and/or references to
chromatograms.
Record calculations neatly.
The person conducting the second check of the calculations should be identified
as well.
Copyright©www.gmpsop.com. All rights reserved
Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic means are strictly prohibited.
Page 35 of 52
