Pharmaceutical Engineering & Drug Delivery

To facilitate the implementation of Quality by Design (QbD) for abbreviated new drug application (ANDA), Office of Generic Drugs (OGD) has developed mock QbD examples for immediate release (IR) and modified release (MR) dosage forms. This presentation will provide insight into OGD’s current...

One of the contributing factors in determining targets for the particle size of an API can be the content uniformity of the dosage forms. This work presents a framework established with a model-based specification for particle size of the API that can be used in a bi-directional mode to: a)...

Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, over 40 Quality by Design (QbD) containing applications have been submitted, reviewed, and approved by ONDQA, both within and outside of the pilot. Although challenges still remain, many approaches...

Abstract Science-Based Stability and Packaging Development Under The Umbrella of QbD Rey T Chern Global Pharmaceutical Commercialization Merck Sharp & Dohme A systematic approach for characterization of product stability risks, selection of primary packages and utilization of first-principle...

The manufacture of pharmaceutical drug products has benefited significantly from a QbD approach, including the enabling of continuous production over batch processing. Developing and improving processes for continuous manufacture requires the combined use of process data with process and...

Quality by Design (QbD) is a science and risk based approach for pharmaceutical manufacturing and development. Enhanced product understanding gained from following a QbD based approach, is increasingly being used to select packaging design parameters and to determine optimum storage conditions. The...

We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry. Much has been accomplished and demonstrated, particularly with regard to enhanced understanding of processes and better definition of processing parameters such as CPPs. Design space has become...

Out of all the pharmaceutical dosage forms, the Quality Target Product Profile (QTPP) for the sterile dosage form is the strictest for obvious reasons. One has to pay attention to the critical quality attributes (CQA) to a great extent. This presentation is focused only on the packaging of sterile...

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After the implementation of initiatives such as PAT and QbD, there has been a drive towards efficient manufacturing in the pharmaceutical industry. The concept of "mini-manufacturing" of drugs, as opposed to mass production of drugs, has shown promise in this area. We describe one such "mini-...