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

Quality by Design (QbD) refers to a holistic approach towards drug development. The purpose ofresearch was to implement quality by design to study prospective process validation of 4 mg SalbutamolSulphate Tablets with risk-based approach. Validation is one of the important steps in achieving andmaintaining 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 QualityRisk Management. Three initial batches of same size, method, equipment was taken for processvalidation. The critical parameters involved in sifting, dry mixing, preparation of granulating solution,wet mixing, drying, sizing, lubrication, compression were identified and evaluated. The formulationproperties of three initial batches of process validated tablets are compared with the marketed productsof Salbutamol Sulphate Tablets (Astahlin tab and Salbetol tab). Results obtained with this processvalidation data provides high degree of assurance that manufacturing process produces product meetingits predetermined specifications and quality attributes. The output of process validation can be used toincrease productivity, its consistent quality and decreasing the need for processing and marketcomplaints.