Development of sterile dosage forms according to quality by design (QbD) principles
Mehtap Saydam
Sanovel Pharmaceuticals GMBH, Turkey
: J Pharm Drug Deliv Res
Abstract
From the current reported numbers, FDA warning letters and drug recalls show a big increase in year, and sterile dosage forms are covering more than half of all the dosage forms, relate to manufacturing and quality issues. On the other hand, due to patent expirations on generic manufacturing, it is estimated that parenteral dosage forms will be the blockbuster drugs in ten years. Thus pharmaceutical industry needs to change marketing approaches from volume to value. With Quality by Design (QbD) approach to drug development could increase efficiencies, decrease quality related failures and shortages, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD is a systematic approach to development, which begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management. The holistic approach to QbD starts with the definition of a quality target product profile (QTPP) and Critical quality attributes (CQAs). Risk assessment is the next step and should be performed at each step of the implementation pathway. The next step involves development of design spaceand setting control strategy for product quality lifecycle management, which means management of all phases in the life of a product from the initialdevelopment through marketing until the product’s discontinuation. PAT is one of the other important tools of QbD for control strategy development at manufacturing area, which allows real time release. Therefore, quality is generated during process development rather than established in the end product.
Biography
