NEW: PAT (Process Analytical Technology) Draft Guidance from FDA!

GMP-News No 345

8 September 2003

PAT (Process Analytical Technology) Draft Guidance from FDA!


FDA has just passed the FDA Draft Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. This new guideline will be presented by Ali Afnan (FDA) at the PAT Workshop of Heidelberg University to be held in Heidelberg on September 19, 2003.

The purpose of the current PAT (Process Analytical Technology) Draft Guidance is to define the regulatory framework conditions which are to support the voluntary development and implementation of innovative pharmaceutical manufacturing processes and quality assurance activities. The intention of the guideline is also to dispel the fear among pharmaceutical manufacturers that they will suffer regulatory disadvantages as a result of the introduction of new manufacturing methods. This document is not a typical FDA guideline since its focuses on presenting options and principles aimed at promoting innovations.

The guideline was compiled by the Office of Pharmaceutical Science of the Center for Drug Evaluation and Research (CDER) under the leadership of the Process Analytical Technology Steering Committee with members from the CDER, the CVM (Center for Veterinary Medicine) and the Office of Regulatory Affairs (ORA). This guideline is expressly not applicable for the CDER's Office of Biotechnology Products.

The guideline sees PAT as a system for the design, analysis and monitoring of pharmaceutical manufacturing by means of real-time measurements of critical quality and performance attributes of starting materials, in-process materials and processes with the aim of ensuring the quality of the finished product. It is emphasized that the term analytical as it is used in PAT is to be understood in a very broad sense.

The guideline covers principles and tools for PAT in detail. An example of this is that time-defined endpoints of manufacturing processes (e.g. mixing for 10 min) can be replaced by process-controlled definitions. This means that FDA allows a certain flexibility in the definition of process conditions. It expressly addresses the real time release, i.e. parametric release, as we knew it up until now mainly for terminal-sterilized products, would be imaginable for all dosage forms!

In a section on "Regulatory Strategies" the guideline describes how FDA seeks to support the industry in the introduction of new PAT technologies. PAT is certainly particularly suitable for the development and introduction of new products but is also recommended for the manufacture of products which already have marketing authorization. Data from PAT experiments on products with marketing authorization could be declared as research data and FDA would in its inspections not ask for these research data but restrict itself to the existing regulatory standards (e.g. the presently permitted methods). Various options as to what a "risk based" approach could look like in the implementation of PAT are described at the end of the guideline. The FDA guideline presented here is a very important element of the FDA initiative "Pharmaceutical cGMPs for the 21st Century: A Risk-based Approach".

Author: Dr. Günter Brendelberger CONCEPT HEIDELBERG

Download the PAT Draft Guidance here:


Talk to one of the authors!

Of current interest: Dr. Ali Afnan, FDA, will speak on the
European Conference on Near Infrared Spectroscopy
The conference takes place in Heidelberg, Germany, from 17-19 September 2003. and is organised for the University of Heidelberg.

You can book a workshop on FDA's PAT separately. Dr. Afnan, FDA, will also participate in this workshop.

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