Retrospective examination of the manufacturing process of paracetamol tablets

ABSTRACT

Retrospective validation is a quality assurance tool which uses the historical data, esp. batch production records, of an existing product to provide the evidence that its process is under control. Retrospective validation does not deal with experiments but it requires systematic and comprehensive data analysis. In this work, the granule humidity content and the tablet thickness in the production process of paracetamol tablets including were validated by using Shewhart charts.