How to ensure Quality by Design

Schedule

1200 – An introduction to the principles of QbD – Walkiria Schlindwein

The term ‘Quality by Design’ (QbD) is not an invention by the pharmaceutical industry, however with respect to pharmaceutical development it is defined in the International Conference on Harmonisation (ICH) guideline Q8(R2) as ‘a systematic approach to development that begins with predefined objectives, emphasises product, process understanding and process control, based on sound science and quality risk management’.

A practical case study will be used to show how QbD, supported by design of experiments and risk assessment, are powerful tools to understand what/why to control plus selecting appropriate ranges to ensure control. 

1230 – QbD in analytical method development: The analytical method lifecycle – Robert Shaw and Steph Turnbull

Advances in analytical technology and automation have facilitated new ways of developing robust analytical methods under challenging timelines, allowing incorporation of Quality by Design (QbD) concepts into the Analytical Method Lifecycle (AML). This joint analytical and statistical framework provides the overarching principles to facilitate the development and ongoing control of methods throughout the full lifetime. The pharmaceutical industry is seeing an increased regulatory expectation to understand method performance through an analytical method control strategy to underpin confidence that the methods will continue to be fit for purpose throughout the changing operations landscape. A key tool in this framework is the use of Design of Experiments (DoE).

Presented here are a series of case studies which will illustrate the practical processes and impact of DoEs and quality monitoring within AML during development and beyond.

1300 – A QbD approach to specifications – Julia O’Neill

Specifications play a central role in QbD. A QbD approach to specifications removes barriers to reducing manufacturing costs and driving continuous improvement. This is true regardless of industry.

In the QbD paradigm, specifications should be established to ensure the final product is acceptable for its intended purpose. Specifications are the key to which all other process controls should be linked and play a critical role in planning for reliable supply using process capability metrics.

However, knowledge of true product requirements may be difficult to obtain. Understanding true product requirements becomes even more challenging for today’s novel breakthrough and orphan drugs, when the amount of data available is often extremely limited during control strategy development.

This presentation will explore alternative approaches for specification setting and recommend specific strategies for both traditional and accelerated product development.

1330 – Panel Q&A and discussion – Walkiria Schlindwein, Steph Turnbull, Robert Shaw, Julia O’Neill and Phil Kay

The panel will discuss:

• Questions from the audience
• The value of increased adoption of QbD methodologies in process and chemical industries
• How more people in more organisations can benefit from QbD approaches

Speaker: Walkiria Schlindwein, Associate Professor at De Montfort University

Walkiria has over 25 years of experience in academia and is currently associate professor in pharmaceutics at the Leicester School of Pharmacy, De Montfort University. She has led the creation of the first MSc in Pharmaceutical Quality by Design, in collaboration with partners from the pharmaceutical industry.

Speaker: Robert Shaw, Principal Scientist in Statistics at AstraZeneca

Robert works within pharmaceutical development and manufacturing. He has worked with AstraZeneca (formerly Zeneca, ICI) for nearly 30 years covering a variety of leadership and technical roles in research, development and production. His main technical interests include DoE, statistical tool development, statistical quality monitoring and control, and in vivo models.

Speaker: Steph Turnbull, Senior Scientist in Statistics at AstraZeneca

Steph’s career started as an analytical chemist, before specialising in process analytics and chemometrics for industrial processes. Statistician, chemometrician, multivariate analyst, designer of experiments, process analytical chemist, she has worked in a wide variety of data-driven areas from data mining through to multivariate statistical analysis, supporting investigations from lab-scale through to global multi-site.

Speaker: Julia O’Neill, Founder & Principal Consultant, Direxa Consulting LLC

Julia has over 30 years of experience bridging statistics and chemical engineering in the pharmaceutical and chemical industries. Her current focus includes statistical, validation and regulatory strategy support for a broad range of both traditional and novel biopharmaceutical products.

Speaker: Phil Kay, Senior Systems Engineer at JMP

Phil was a key scientist in the development of numerous processes for the manufacture of colorants for digital printing at FujiFilm Imaging Colorants. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is also a Royal Society of Chemistry Chartered Chemist and Fellow of the Royal Statistical Society.

Moderator: Benjamin Valsler, Digital editor, Chemistry World magazine

Ben is the digital editor of Chemistry World magazine, producing video and podcasts to accompany the magazine and website. Prior to joining the Royal Society of Chemistry, he was the producer of the award-winning Naked Scientists, making local and national radio programmes for the BBC, the Australian Broadcasting Corporation and Primedia in South Africa.