FDA's Risk-based Approach - Tools for Risk Analysis

GMP News No. 309

29 April 2003

 FDA'sRisk-based Approach -

Toolsfor Risk Analysis 

FDA is reviewing the existing GMP regulations within the framework ofthe risk-based approach. On the one hand, the Agency intends tooptimise the resources, i.e. it wants to focus its attention oncritical processes and pay less attention to uncritical ones. But on theother hand, FDA also wants to check whether certain GMP requirementslaid down in the regulations will have to be revised for a risk-basedapproach. A first example for this is the re-orientation of the Part-11requirements. Here, the risk for the product caused by theuse 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-criticalprocesses (e.g. aseptic processing or biotechnological products), therequirements will probably be tightened if FDA's analysis shows that theGMP requirements are no longer sufficient or up-to-date (this is true formany guidelines, e.g. from the 80s). Current example: the revision of theAseptic Guides from '87.

The importance of the topic of "riskassessment" for FDA is e.g. demonstrated by the fact that thecentres CDER and CBER organise a workshop from 9-11 April that wasannounced in the FederalRegister.

A workshoptitled "A Drug Quality System for the 21st Century" to be heldin Washington from 22-24 April will also deal with the risk-basedapproach.

What is also interesting is FDA's"Concept Paper" on RiskManagement Programs created on 3 March. 

In the following youwill find a list of those tools that are most frequently mentioned inconnection with risk analysis: FMEA and HACCP

References to FMEA/HACCP in Pharma-relevantGuidelines

FDA Presentations on Risk Analysis

Preventing Contamination: AsepticProcessing 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

On this site you will find informationand links to various aspects of FMEA: FMEA books http://www.fmeainfocentre.com/books.htm

FMEA literature and references

FMEA research

FMEA training, services and consultancy 

FMEA standards

FMEA software

The FMEA Info Centre also has a download-page http://www.fmeainfocentre.com/downloads.htm
where you can download specific FMEA documents (FMEA tutorials, FMEAstandards, ...). 

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 



Recommended Book (shows theimplementation ofHACCP in aseptic processes)

Aseptic Processing: The Importance ofMicrobiology and Environmental Monitoring in Media Fill Validation

Aseptic Processing: The Importance ofMicrobiology and Environmental Monitoring in Media Fill Validation.Introduction to the Environmental Monitoring of Pharmaceutical Areas.

Author: Dr. Michael Jahnke



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