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UK Annual Meeting

“Quality by Design”
13th November 2008
Venue: Cairn Hotel, with the dinner afterwards at the Harrogate International Centre, Harrogate

Programme and registration form

Table Top Exhibitors

To download the list of the sponsors (with a direct link to their websites) please click here .

Agenda
08:00	Registration, Coffee & Exhibition Opens
09:15	Chairman's remarks Alan Halstead, Validation Manager, PM Project Services Ltd
09:30	Transfer of Best Practice in Manufacturing, Design & QA. Dr. Ali Afnan, Process Analytical Technologist, FDA/CDER/OPS

The business of developing, manufacturing and marketing pharmaceuticals has been thriving for many years. Yet it has remained largely unchanged in its practices, resulting in manufacturing lagging other industries.

The pharmaceuticals market, however, is different from other sectors as quality and market demands are managed by third parties and not the consumer. The regulatory bodies "assure through oversight" safety, efficacy and quality, and the medical professionals prescribe the products. Indeed the consumer has little control over quantity and quality of consumed products. This is unique, and is not comparable to other sectors, for example electronics.

Post discovery, the "business" of developing a new chemical or biological entity into its final dosage form is an engineering process. So why aren't 3 sigma manufacturing processes tolerated in other industries, and yet they are the norm in this industry?

Is it not time to look at the 21st century principles of design, manufacturing and quality assurance – as practiced in other industries – and embrace those practices into the pharmaceuticals industry?

Agenda
10:15	Delivering business benefit through QbD Lindsay Wylie, Director of Design for Manufacture, GSK

Application of QbD to drug development and manufacture can provide significant business benefit to Pharma companies. By applying tools and techniques such as Risk Assessment and Process Analytics, companies can focus development activities, ensure that robust and capable manufacturing processes are developed and enable lifecycle management. This presentation will exemplify the use of QbD to deliver a robust control strategy which will provide business benefit to the company.

Agenda
10:45	Break & Exhibition
11:15	Delivering business benefit through QbD Lindsay Wylie, Director of Design for Manufacture, GSK
11:45	Design Space of Drug Product: Empirical Modelling based on Multivariate Projection Methods Dr. Theodora Kourti, Senior Technical Director, GlaxoSmithKline In this approach, the definition of design space is taken literally and Quality is expressed (in one model) as a function of the multidimensional combination of raw material ( API and excipients), parameters of the process (Granulation, Drying, Blending, Compression, Coating) and IPC’s. A multivariate structure is also maintained for quality. Separate models provide support for control strategy in a feed forward mode. Multivariate projection methods are used for modelling, while scientific and other knowledge is incorporated to create hybrid models. The structure of the multi- factor DOE’s required to derive such a model is discussed, as well as ways to develop control strategy based on empirical data.
12:15	QbD/PAT Regulatory Submissions - Wyeth's experiences Graham Cook, Sr Director Process Knowledge/Quality By Design, Wyeth Pharmaceuticals This presentation will discuss some issues with global QbD/PAT regulatory submissions and Wyeth's experiences, including a case study.
12:45	Lunch & Exhibition
14:00	Product Quality Lifecycle Implementation (PQLI) and Control Strategy Case Study Dr. Line Lundsberg-Nielsen, PAT & QbD Senior Specialist, NNE Pharmaplan and Co-Chair of the ISPE PQLI Control Strategy Team PQLI is an initiative that ISPE is leading for practical and pragmatic implementation of ICH Guidances Q8, Q9 and Q10 (Pharmaceutical Development, Risk Management and Quality Systems). It is an industry lead initiative with regulatory input from the 3 ICH regions of US, EU and Japan. The initial work has concentrated on Criticality, Design Space, Control Strategy and Legacy Products. The presentation will cover the content of PQLI, the regulatory and industry interactions and will lead on to a case study that the Control Strategy team has initiated to illustrate the importance of Control Strategy from development through manufacturing to the patient.
14:45	Quality by Design and the Impact on Equipment Choice - Learning from the past Keith Plumb, Director, Integral Pharma Services Ltd ICH Q8 requires that the critical quality attributes (CQAs) are identified as part of the development of a pharmaceutical product, along with the selecting an appropriate manufacturing process. Also required is the determination of the material attributes and process parameters that can have an effect on the product CQAs. These CQAs can include product purity, potency, stability and drug release and possible aerodynamic properties (inhaled products), sterility and those properties such as particle size distribution and bulk density that affect downstream processing. The development work is required to identify and rank parameters such as operational aspects, equipment and input material that have potential to have an impact on product quality. The linkage between the input variables, process parameters and CQAs is called design space and this must be determined. As an example the initial moisture content, particle size and temperature could have an impact on the CQAs of a product during a drying step. It is also possible that the method of heating and the level of agitation will also have an impact on the CQAs. The first three parameters are largely driven by the process selection but the second two are more a function of the equipment. This means that the definition of the design space is not only a function of the process but also a function of the type of equipment. This presentation will discuss the possible parameters that could have had an impact the CQAs for an inhalation API that was dried at two stages during its formulation and the impact of equipment selection on the process parameters.
15:15	Break & Exhibition
15:45	QbD for Legacy Processes – Implementing QbD from API manufacturing to the tablet Dr. Hedinn Valthorsson, Novartis Pharma, Switzerland
16:15	Summary and Q&A with Panel
17:00	Close