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FDA has just passed the FDA Draft
Guidance for Industry PAT - A Framework for Innovative Pharmaceutical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Analytical Technology) Draft Guidance is to define the regulatory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
Source:
Download the PAT Draft Guidance here: http://www.fda.gov/cder/guidance/5815dft.pdf
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