Trending is a regulatory requirement mandated by the FDA. A warning letter, or FDA483, could be issued for not having a trending procedure. Out-of-specification (OOS) result investigations continue to be one of the most commonly observed cGMP deficiencies during the inspection of quality control laboratories.
Data trending / tracking is intended to be a proactive approach and therefore trends should be defined, identified timely, and actions implemented quickly. Maintaining a tracking log of OOS results, and having established procedures for investigating OOS results, and providing user training on data tracking are all critical procedures due to potential public safety issues following the release of a non-conforming product. OOS related data resulting from analysis should be reported periodically and reviewed by the management to determine appropriate corrective actions.
We can help you manage OOS results which include assessment of each individual case and the analysis of data for trends in order to detect potential problems and implement appropriate corrective and/or preventive actions.
We also offer SOP documentation services for:
- Out-of-Specification Data Trending
- Handling Out-of-Trend Results
- Handling OOS results (updated according to FDA’s final OOS guidance)
- Laboratory Failure Investigation
- Corrective and Preventive Actions
- Investigating Manufacturing Incidents
If you would like more information, get in contact with us directly here.