Use of Product Quality Review to Evaluate Quality and Process Capability: A Case Study of Ibuprofen in a Model Tablet Manufacture

Abstract

Product quality review in the pharmaceutical industry is a regulatory requirement comprising periodic evaluation of licensed pharmaceutical products to verify consistency of the manufacturing process and appropriateness of specifications. In this study, product quality and process capability in the manufacture of ibuprofen tablets were evaluated. A quality review of 39 batches produced in the year 2019 was conducted. Components for review included starting materials, critical in-process controls, finished product results, non-conformances, deviations and quality relevant product complaints. Control charts and statistical analysis were used to trend results and compute process capability indices. Starting materials, in-process controls and finished product results complied with quality specifications. Process capability indices for tablet weight, size, dissolution and assay were greater than 1.0. The study showed that the established quality attributes of ibuprofen tablets were consistently produced and it was concluded that the manufacturing process was controlled and sufficient to assure reproducible outcomes.