FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing

GMP News No. 496

29 November 2004

 FDA White Paper: 
Innovation and ContinuousImprovement in Pharmaceutical Manufacturing


Besides the FDA Guidance for Industry onPAT (Process Analytical Technology) dated September 2004 (GMP News from October 2004) FDA published at the same time a so-called White Paperwith the title "Innovation and Continuous Improvement inPharmaceutical Manufacturing".This publication is a summarizingreport of the FDA PAT Team and the Manufacturing Science Working Group, inwhich it is described what has so far been reached and which steps will nextbe suggested to achieve the desired state of pharmaceutical manufacturing.The entire PAT initiative has a key function in the primary effort of theFDA to completely re-define the pharmaceutical GMP rules for the 21century.

In the White Paper, consisting of 39pages, FDA points out that it is prepared tocommunicate with different places and organizations to get PAT going.

The leading thought of the White Paper isto express a vision of the desired state for the pharmaceuticalmanufacturing in the 21st century. Exactly this is the central request ofPAT.

The present situation is described amongother things as follows:

  • Inefficient and cost-intensive - alsothe regulatory requirements contributed to this
  • The examination of physical parametersin the last decades lagged behind (compared to chemical examinations)

The future goal of a modernpharmaceutical manufacturing in this FDA White Paper is described with thefollowing key words:

  • Continuous Improvement instead of Corrective Actions
  • Development of a deep understanding ofthe processes and systems (it is about a complete, also mechanisticalunderstanding of the manufacturing processes)
  • Effective and efficient design of themanufacturing processes
  • Critical sources of variability in themanufacturing process to be identified and explained
  • These variabilities then to becontrolled in the manufacturing processes
  • And therewith the quality of theproduct (with the variability as small as possible) to be reliablypredictable (Process Capability)
  • Continuous real-time measurements
  • Statistical process control

You will find the complete document"Manufacturing Science White Paper: Innovation and ContinuousImprovement in Pharmaceutical Manufacturing" here:


The new FDA White Paper on PAT containsdetailed information. Nevertheless, further clarification is necessary.

This is why theUniversity of Heidelberg organizes an international conference inco-operation with CONCEPT HEIDELBERG about Process AnalyticalTechnology. Please note that this event is not an ECA Conference.However, ECA strongly supports the University of Heidelberg e.g. my meansof marketing co-operation. Focus is the concrete conversion of PAT examples intopharmaceutical 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 amember of the PAT Team of FDA speaks at this PAT Conference inHeidelberg. 

The conference will take place on 27-28 January 2005in Heidelberg - directly following the conference „FDA’sNew Quality Systems and Risk Approach", taking place on 26/27 January2005, also in Heidelberg.

You find both programs here. 


Dr. Günter Brendelberger


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