IJCRRI Journ Cur Res ReInternational Journal of Current Research and ReviewI Journ Cur Res Re2231-21960975-5241Radiance Research Academy4915https://doi.org/10.31782/IJCRR.2026.181501Healthcare Quality by Design (QbD)-Based Regulatory Dossier Preparation of Imiglucerase: A Review       KhadeHarshada R.PiseShilpa140820265)16This article is copyright of Popeye Publishing, 20092009This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.

The concept of Quality by Design (QbD) enables the incorporation of scientific knowledge and risk management during the development of drugs. Imiglucerase is a recombinant biological enzyme that serves in the treatment of Type 1 Gaucher disease and thus calls for a thorough analysis regarding quality. This paper provides an analysis of the use of QbD in preparing the regu latory dossier of this product. This involves an overview of several aspects including the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs), risk assessment and control strategy of Imiglucerase development. The relevance of the Common Technical Document (CTD) and electronic Com mon Technical Document (eCTD) in compiling quality, nonclinical and clinical information about the drug will also be addressed in the paper.

Quality by Design (QbD) Imiglucerase Regulatory Affairs Regulatory Dossier Common Technical Document (CTD) Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Critical Material Attributes (CMAs) Quality Risk Management (QRM) Biopharmaceuticals.