抽象的

Quality by Design-A Trending Aspect for Pharmaceutical Product Development

Anwar Khan, Sabir Alam, Rupa Gupta, Rizwanul Hasan, Mohini Chaurasia, Mohsin Ali Khan

Regulatory bodies are now a days concerned with the safety, efficacy and quality of the pharmaceutical drug products. Quality is first priority of all regulatory bodies, it is at high priority for triple P factor (patient, pharmacist and physician). It serves as a linkage between pharmaceutical ind ustries and regulatory authorities for designing, manufacturing and consistently delivering safe and efficient product.

It mainly focuses on fabricating and designing formulations and manufacturing processes to ensure predefined product quality. It is base d on the ICH guidelines Q8 for pharmaceutical development, Q9 for quality risk management, Q10 for pharmaceutical quality systems. Some of the important effective elements of QbD are to define the target profile that what is the requirement of pharmacist, physician and patient (TPP -QTPP) and then measuring the criticality for achieving that target (CQA), and analyzing the risk assessment of variables associated with materials and cont rolling processes to produce consistent quality over time. The objective of this review is to discuss the concept of quality by design and describe its application in pharmaceutical product development.