Formulation Design of the Oral Disintegrating Tablets Including Alfuzosin Hydrochloride with Risk Evaluation via Quality by Design
Today, it is generally accepted that quality cannot be tested or inspected into a finished product, but rather that quality, safety and effectiveness must be “designed” and built into a product and its manufacturing process. In the traditional approach, the production processes and process parameters are determined to be unchanged in order to avoid any variety in the quality of the product. Thus, required specifications are met and the product quality is measured by finished product tests1 . In order to design quality into a product, the requirements for the product design and performance must be well understood in the early design phase. In pharmaceuticals, these product requirements can be justified as Quality Target Product Profile (QTPP) which is also defined as “a prospective summary of
ACTA PHARMACEUTICA SCIENCIA Dergisi 52/2/7. Sayısı İçin Tıklayınız.