FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing

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. 

Author: 
Dr. Günter Brendelberger
CONCEPT HEIDELBERG