GMP News No. 309
29 April 2003
FDA's Risk-based Approach -
Tools for Risk Analysis
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
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
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
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
New Part 11 Strategy - New FDA Requirements on and Implementation of
Electronic Records/Electronic Signatures