A company recently received this 483 observation:
….. Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
Specifically, during the walk through, I observed the laboratory logbook for pH, HPLC, GC, viscometer and micro testing data to be missing the second signature showing the original records have been reviewed. When I requested these documents for review, I observed all the logbooks had received a review and signature by a second individual dated after our discussion. It was explained by firm management that the majority of products documented on these logs had been distributed. For example, HPLC sample testing log data did not receive a second review until two months after the data entry.
For more observations pertaining to laboratory controls see Issue 1029 available today. It also has observations pertaining to manufacturing controls, packaging and labeling controls and medical device manufacturing controls.