Nowadays regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities. The aim of this review was to study regulatory science even in the nano-pharmaceutical early development. Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. A risk assessment was performed with various process and formulation parameters to determine their impact on particle size and encapsulation efficiency (CQAs) of nanomaterials. In the present review basic consideration of the QbD approach, its historical background and regulatory needs are discussed. In detail explanation of elements of QbD i.e. method intent and risk assessment is given. Application of QbD to pharmaceutical and biopharmaceutical processes, development and unit operation associated with it are briefly mentioned.
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