|
Besides the FDA Guidance for Industry on
PAT (Process Analytical Technology) dated September 2004 (see our GMP News
from October 2004) FDA published at the same time a so-called White Paper
with the title "Innovation and Continuous Improvement in
Pharmaceutical Manufacturing".This publication is a summarizing
report of the FDA PAT Team and the Manufacturing Science Working Group, in
which it is described what has so far been reached and which steps will next
be suggested to achieve the desired state of pharmaceutical manufacturing.
The entire PAT initiative has a key function in the primary effort of the
FDA to completely re-define the pharmaceutical GMP rules for the 21
century.
In the White Paper, consisting of 39
pages, FDA points out that it is prepared to
communicate with different places and organizations to get PAT going.
The leading thought of the White Paper is
to express a vision of the desired state for the pharmaceutical
manufacturing in the 21st century. Exactly this is the central request of
PAT.
The present situation is described among
other things as follows:
- Inefficient and cost-intensive - also
the regulatory requirements contributed to this
- The examination of physical parameters
in the last decades lagged behind (compared to chemical examinations)
The future goal of a modern
pharmaceutical manufacturing in this FDA White Paper is described with the
following key words:
- Continuous Improvement instead of Corrective Actions
- Development of a deep understanding of
the processes and systems (it is about a complete, also mechanistical
understanding of the manufacturing processes)
- Effective and efficient design of the
manufacturing processes
- Critical sources of variability in the
manufacturing process to be identified and explained
- These variabilities then to be
controlled in the manufacturing processes
- And therewith the quality of the
product (with the variability as small as possible) to be reliably
predictable (Process Capability)
- Continuous real-time measurements
- Statistical process control
You will find the complete document
"Manufacturing Science White Paper: Innovation and Continuous
Improvement in Pharmaceutical Manufacturing" here:
http://www.fda.gov/cder/gmp/gmp2004/manufSciWP.pdf
The new FDA White Paper on PAT contains
detailed information. Nevertheless, further clarification is necessary.
This is why the
University of Heidelberg organizes an international conference in
co-operation with CONCEPT HEIDELBERG about Process Analytical
Technology. Please note that this event is not an ECA Conference.
However, ECA strongly supports the University of Heidelberg e.g. my means
of marketing co-operation. Focus is the concrete conversion of PAT examples into
pharmaceutical practice. Addressed among other things are:
.
- Physical Measurements
- Multivariate Measurement Techniques
- Process Capability
- Process Understanding
- PAT Implementation
- Real-Time Product Release
- Data Management
- The Impact of PAT on Quality Assurance
Through Ali Afnan of FDA also a
member of the PAT Team of FDA speaks at this PAT Conference in
Heidelberg.
The conference will take place on 27-28 January 2005
in Heidelberg - directly following the conference „FDA’s
New Quality Systems and Risk Approach", taking place on 26/27 January
2005, also in Heidelberg.
You find both programs here.
|
