Description
An out-of-specification result is not a failed batch, and it is not a nuisance to be retested away. It is a question the laboratory has to answer with evidence.
What you will be able to do
- Recognise and react. Tell OOS, OOT and atypical results apart, know what EU GMP requires, and act correctly in the first minutes.
- Investigate the laboratory. Carry out the supervisor’s checks, test hypotheses with evidence, and invalidate a result only when an error is shown.
- Take it into manufacturing. Review production when the laboratory is cleared, and use retesting and resampling correctly.
- Report every result. Use averages and outlier tests only where they belong, and keep the data complete and reviewed.
- Decide and learn. Reach a defensible batch decision, handle stability and trend results, and learn from the pattern of investigations.
Who it is for
QC analysts and laboratory supervisors, QA reviewers who approve laboratory investigations, and Qualified Persons who rely on them. It assumes you work in or with a GMP laboratory.
Basis
EudraLex Volume 4, Chapter 6 (2014), Chapter 1, Chapter 4; Annex 16, 1.7; Annex 11, 9.
