ICH Q12 Examples – Pharmaceutical Product Lifecycle Management Examples – FDA Guidance
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Janet Woodcock is the new acting FDA Commissioner – why QbD scientists are hopeful
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COVID-19 Vaccines FDA Advisory Committee Meetings – Pfizer & Moderna
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QbD for Drug Device Combination Products – Part 2
This is the part 2 of the interview from Manfred on the drug device combination product. If you haven’t yet, please listen to the first part of QbD for Drug Device Combination Products. Today, we cover: Design Controls versus Quality by Design (QbD) – how is it different? When...
How To Apply QbD to Drug Device Combination Products
Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...
Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...
Pharmaceutical Quality by Design Book – Practical or Theoretical? [Interview]
A new book on Quality by Design was recently published. When I read such a book on QbD, I ask – “is it merely theoretical or actually practical?” As a scientist who deals with the reality of messy biologics and constraints of time and resources at the office, I...
Faster Drug Approvals with this underused QbD tool
“Does anyone not use QTPP?” was the original question asked to the ~21,500 scientists. Being a Quality-by-Design community, many claimed their organizations are using the essential element of QbD – the Quality Target Product Profile. Was it true? However, data tells us otherwise. Today, Adria Tyndall share her research...
Influenza vaccines – Quality module
Recently, EMA (European Medical Agency) published a Guideline on Influenza Vaccines – Quality Module. Though the main focus of this EMA guideline was not QbD or PAT, one section – 4.1.1.6. Characterisation – was relevant to QTPP, CQA, CPP and hints on the details of the design space (albeit...
QbD for Dry Powder Inhalation Formulation (Combination Product)
Dr. Edina Pallagi is the QbD pioneer of Hungary. The University of Szeged team recently published, “New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach” For a complimentary PDF access, download the QbD case study by Sept. 5 The one-sentence takeaway is: By...