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

Sarah Vugigi; Christian Mshila; Ikoni Ogaji

Sarah Vugigi Department of Pharmaceutical Chemistry & Pharmaceutics, School of Pharmacy, Kabarak University, P.O. Private Bag Kabarak-20157, Kenya.
Christian Mshila Elys Chemical Industries Ltd., P.O. Box 40411-00100, Nairobi, Kenya.
Ikoni Ogaji Department of Pharmaceutics and Pharmaceutical Technology, University of Jos, P M B 2084-930001, Jos, Plateau State, Nigeria.

Keywords: Capability, pharmaceutical, process, product, quality, review

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.