 The
QbD / PAT Conference 2010
29 September - 1 October 2010,
Heidelberg, Germany
Regulatory Background and Objectives
In many minds it was only at the
turn of the century that both industry and regulatory agencies began to
fully comprehend that the ability to meet society’s ever increasing
healthcare expectations would require a significant step change in the
industry’s performance.
Over the last 50 years clinical science, engineering science
underpinning good manufacturing practice and the analytical science
pivotal to the concept of validation are a few examples of complimentary
scientific disciplines which deployed collectively have delivered
significantly greater healthcare benefits currently enjoyed by society
than they would have if used individually.
Convergence is not new. It has provided the multidisciplinary platforms
of complementary sciences underpinning the development of pharmaceutical
science for decades.
What has changed is the speed and breadth of development of these
complementary sciences and the opportunities these changes offer to
totally change the industry’s business model.
However in spite of the PAT Guidance, cGMP for the 21st Century and the
Critical Path Initiative and latterly QbD which described the “building
blocks” to address the key challenges to:
-
encourage and manage
innovation while ensuring high quality
-
identify and adopt appropriate
technologies which will IMPROVE overall quality
-
successfully shift from
empirical to science based standards for manufacturing process
quality
7 years later industry is still
failing to sponsor the levels of innovation necessary to develop the
desired more efficient, agile, flexible pharmaceutical manufacturing
sector capable of reliably producing high-quality drug products without
extensive regulatory oversight from both regulatory / industry
perspectives.
What hasn’t changed is industry / regulatory conservatism
As a direct result:
-
manufacturers have been slow
to adopt PAT/QbD
-
the concept of design space is
not clearly understood
-
regulatory approaches have not
evolved adequately
leading to high levels of
regulatory uncertainty within the industry.
Specifications are still based on empirical compendial standards rather
than science based on specific process and product need.
Concurrently the Pharmaceutical industry has undergone and is still
undergoing dramatic change the scale of which few would have predicted.
Business performance expectations applying traditional business models
are becoming increasingly difficult to sustain.
The changes outlined by the critical path initiative previously seen as
optional will soon become an imperative.
The Pharmaceutical sciences will not only have to evolve more rapidly
but become far more convergent than ever before.
From these perspectives
PAT and QbD are not mutually exclusive they are complementary.
Against this background this years conference will again have a
significant interactive workshop content focusing on the respective
roles PAT and QbD will play redressing the issues outlined above with an
emphasis on convergence.
The first two workshops will focus on:
-
Process Understanding -
Facilitating the Transition between Process Validation and
Continuous Verificatio
-
Material Science - How Can
Material Science Bridge the Gap Between API and Drug Product
Manufacture?
As product, process, scientific
understanding and risk management changes over time the concept of QbD
being dynamic will also raise additional significant challenges critical
to achieving the desired state which are the subjects of the remaining
workshops :
The Transition from Batch to Continuous Processing – An Overview of the
Respective Sampling, Measurement and Control Issues
Performance-Based Quality Specifications - Establishing a Science-Based
Target for Pharmaceutical Manufacturing
The conference programme will also include presentations on a range of
complimentary topics from academia, industry, and regulatory agencies
covering:
This programme will also include
short presentations from vendors providing equipment / support for PAT
and QbD initiatives. .
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