FDA is reviewing the existing GMP regulations within the framework of
the risk-based approach. On the one hand, the Agency intends to
optimise the resources, i.e. it wants to focus its attention on
critical processes and pay less attention to uncritical ones. But on the
other hand, FDA also wants to check whether certain GMP requirements
laid down in the regulations will have to be revised for a risk-based
approach. A first example for this is the re-orientation of the Part-11
requirements. Here, the risk for the product caused by the
use of the software forms the basis for the scope of the measures to be taken (e.g.
concerning validation, Audit Trail).
Especially with regard to GMP-critical
processes (e.g. aseptic processing or biotechnological products), the
requirements will probably be tightened if FDA's analysis shows that the
GMP requirements are no longer sufficient or up-to-date (this is true for
many guidelines, e.g. from the 80s). Current example: the revision of the
Aseptic Guides from '87.
The importance of the topic of "risk
assessment" for FDA is e.g. demonstrated by the fact that the
centres CDER and CBER organise a workshop from 9-11 April that was
announced in the Federal
Register.
A workshop
titled "A Drug Quality System for the 21st Century" to be held
in Washington from 22-24 April will also deal with the risk-based
approach.
What is also interesting is FDA's
"Concept Paper" on Risk
Management Programs created on 3 March.
In the following you
will find a list of those tools that are most frequently mentioned in
connection with risk analysis: FMEA and HACCP
References to FMEA/HACCP in Pharma-relevant
Guidelines
FDA Presentations on Risk Analysis
Preventing Contamination: Aseptic
Processing Risk Factors by Rick Friedman, FDA (October 2002) http://www.fda.gov/ohrms/dockets/ac/02/slides/3900S2_06_Friedman-revised.ppt
Overview of FMEA
http://www.fmeainfocentre.com/
On this site you will find information
and links to various aspects of FMEA: FMEA books http://www.fmeainfocentre.com/books.htm
FMEA literature and references
http://www.fmeainfocentre.com/publications.htm
FMEA research
http://www.fmeainfocentre.com/research.htm
FMEA training, services and consultancy
http://www.fmeainfocentre.com/consultancy.htm
FMEA standards
http://www.fmeainfocentre.com/standards.htm
FMEA software
http://www.fmeainfocentre.com/software.htm
The FMEA Info Centre also has a download-page http://www.fmeainfocentre.com/downloads.htm
where you can download specific FMEA documents (FMEA tutorials, FMEA
standards, ...).
Finally the FMEA Info Centre has a discussion list http://www.fmeainfocentre.com/fmea_community.htm
to allow FMEA-users to share ideas and knowledge about FMEA.
Software Providers
http://www.apis.de/
http://www.plato-ag.com/plato/home_eng.nfs
Recommended Book (shows the
implementation of
HACCP in aseptic processes)
Aseptic Processing: The Importance of
Microbiology and Environmental Monitoring in Media Fill Validation
Aseptic Processing: The Importance of
Microbiology and Environmental Monitoring in Media Fill Validation.
Introduction to the Environmental Monitoring of Pharmaceutical Areas.
Author: Dr. Michael Jahnke
http://www.euromed.uk.com/dhi/dhi_jahnkeintro.htm
GMP News with Information on Risk
Analysis (HACCP)
HACCP - Getting Closer and Closer (GMP
News of 06/04/2001)
GMP Education Courses That Cover Risk Analysis
for Part 11 Compliance
FDA's
New Part 11 Strategy - New FDA Requirements on and Implementation of
Electronic Records/Electronic Signatures
Barcelona, Spain, 12-13 May 2003
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