| Summary: | Validation managers identified problems with validation sampling as one of their most troubling problems in process qualification (PQ) execution. Missing samples may have very significant consequences. When sampling requirements are complex and there is heightened potential for errors, designated sampling pages are recommended. These pages clearly describe the samples to be withdrawn, list requested samples, and require signature and date of the person performing the sampling. Diagrams or digital photos may be included. The sampling pages provide a definite focus on the sampling process for personnel obtaining samples. Pre-printed labels, sampling containers, and other measures to facilitate sampling are discussed.
|
|---|