Implementation of Quality by Design to the Process Validation with Risk-Based Approach for Quality Assurance of Salbutamol Sulphate Tablets

Author(s)

Bhitre, M. J., Ingale, A. V., Mene, R. A.

Author's Affiliation

Abstract

Quality by Design (QbD) refers to a holistic approach towards drug development. The purpose of research was to implement quality by design to study prospective process validation of 4 mg Salbutamol Sulphate Tablets with risk-based approach. Validation is one of the important steps in achieving and maintaining the quality of the final product. Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters, Design Space and control strategy are identified with the help of Quality Risk Management. Three initial batches of same size, method, equipment was taken for process validation. The critical parameters involved in sifting, dry mixing, preparation of granulating solution, wet mixing, drying, sizing, lubrication, compression were identified and evaluated. The formulation properties of three initial batches of process validated tablets are compared with the marketed products of Salbutamol Sulphate Tablets (Astahlin tab and Salbetol tab). Results obtained with this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes. The output of process validation can be used to increase productivity, its consistent quality and decreasing the need for processing and market complaints.

Keywords

QTPP, CQA, CPP, QRM, Design Space, Control Strategy

Cite This Article

Bhitre, M. J., Ingale, A. V., Mene, R. A. (2013). Implementation of Quality by Design to the Process Validation with Risk-Based Approach for Quality Assurance of Salbutamol Sulphate Tablets. International Journal of Pharmaceutical Research Scholars (IJPRS), 2(2), 175-187.