Concurrent process validation: A case study for Artesunate and Amodiaquine tablets

Abstract

Process validation is a requirement of Current Good Manufacturing Practices (cGMP). The essence of process validation is to ascertain the quality of a product throughout its production life cycle. The various steps in manufacturing processes must be validated as it is essential for quality to be built into the manufacturing processes of drugs. In this study, we discuss the Process validation of Artesunate (Art) tablets and Amodiaquine (Amod) tablets. The following critical tests were performed on the blend; Assay, blend uniformity studies, blend characteristics and flowability properties (Bulk Density, Tap Density, Compressibility Index, Hausner Ratio), resistance to Segregation studies, Loss on Drying and Blend hold-time studies. The following analytical tests were performed on the compressed tablets; Identification, weight variation, Disintegration, Hardness, Average weight, Loss on Drying, Friability, Assay, Dissolution, Thickness and Uniformity of Dosage Unit. The following were performed on the packaged finished products; leak test, Print quality, carton seal integrity. Percentage yield was also determined. The following statistical tools were used in the data evaluation; F-test, Shapiro-Wilk test, Kurtosis, Skewness, T-test emanating from regression analysis, Tests for Normality and Tests for Significant differences. Results indicated an acceptable level of homogeneity within a batch and a high level of consistencies between batches. The manufacturing process was concluded to be capable and stable to assure quality and safe products.