22/23 September 2020
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
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