Journal of Developing Drugs
Open Access
ISSN: 2329-6631
ISSN: 2329-6631
M V Narendra Kumar Talluri
National Institute of Pharmaceutical Education & Research, India
Posters-Accepted Abstracts: J Develop Drugs
FDA has approved a few New Drug Applications (NDAs) with regulatory flexibility for Quality by Design (QbD) based analytical development approach. Quality by design is defined in ICH Q8 (R1) guidelines as ��?a systematic approach to pharmaceutical development starting with pre-defined objectives with an emphasis on product and process understanding control��?. Within the pharmaceutical industry there is increasing discussion about the principles of QbD analytical methods. For many years, analysts used to develop methods based on trial and error approach. With this traditional approach, many unexpected results are observed during the stage of validation in analytical methods including the disappearance of peaks or appearance of new peaks creating a need to go back from starting of the method development steps. This approach is very tedious and time consuming and it cannot give robust results. This can be avoided by applying quality by design approach. It allows the analytical method for movement within method operable Design Space (DS). This approach reduces the number of Out-Of-Specification (OOS) results due to the robustness of the method within the DS. It is a current trend among pharmaceutical industry to implement quality by design in analytical method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q8, 9, 10).