A company recently received this 483 observation:
…. Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Specifically, Laboratory notebooks intended to record raw data such as weights, instruments, method, and calculations are not filled out as performed with data obtained from titration or HPLC tests of finished drug products as per your procedure SOP…, “Laboratory Notebook Issuance, Page Format, Review and Reconciliation”. According to the QC Laboratory Manager, raw data is initially written on a piece of paper and then transcribed into the laboratory notebook. The original paperwork is then discarded. During our walk-through, we observed raw data discarded in your HPLC room trash can.
For more observations pertaining to lab controls, see Issue 1049 available today. It also has observations pertaining to manufacturing controls, packaging and labeling and medical device manufacturers.