Pre-Conference Workshop Microbiological Deviations (OOS/OOL) to the 8th European Microbiology Conference

5 May 2015

Prague, Czech Republic

Course No 9282

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Speakers

Dr Sven M. Deutschmann, Roche
Dr Esther Marty, Novartis
Dr Wolfgang Eder, Roche Diagnostics
Dr Guy Roehrig, Lilly
Dr David Roesti, Novartis

Objectives

This Workshop will show you the regulatory background as well as provide you with practical guidance for a scientific and systematic way to handle microbiological deviations. Experienced Experts will give you guidance on how to handle them in the different fields of microbiological QC like
Pharmaceutical Water
Environmental Monitoring
Objectionable Microorganisms
Sterility Testing
Endotoxin testing
Biological/biopharmaceutical manufacturing

Background

Until today the non-compliant handling of OOS is one of the most common deviations in FDA’s “483s” and Warning Letters, despite the different guidelines and recommendations for the handling of OOS results.

The FDA ”Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories” points out, that during FDA Inspections Re-Test Results should be assessed and verified with a special particularity. Especially the rationale for the re-testing should be challenged. Unfortunately, the FDA Guidance for Industry “Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production” rather addresses the handling of classical chemical analysis OOS and does not really provide help for the handling of microbial deviations.

On the contrary to chemical/physical tests in quality control, microbial OOS results necessitate special questions and involve challenges like the constrained recovery, effects of stressed microorganisms, influence of the used nutrient media inhomogeneous distribution of the microorganisms and so on. Following, a comprehensive root cause analysis and risk assessment is extremely important, including the necessary documentation.
Furthermore, basic definitions are also important. What are “Out-of-Specification”, what are ”Out-of-Limit” and what are “Out-of-Expectation” results and what are the necessary approaches and strategies to handle such results according to regulatory requirements?

Target Group

Employees and managers of microbiological Quality Control laboratories who are
involved in
Testing of microbiological quality
Handling and risk assessment of microbiological deviations
Root cause analysis
Microbiological CAPA
Communication and tracing of microbiological contract laboratories

Programme

Handling of OOL/OOS Results in Biopharmaceutical Manufacturing
Limit Definitions
Deviation Management
Case-by-Case Assessment of Bioburden Excursions
Dr Sven M. Deutschmann, Roche

EM Deviation Strategy - Non Sterile Drug Product Manufacturing
Clear differentiation between initial non-critical and critical deviations
Established standard procedure
Clear criteria for evaluation
Dr Esther Marty, Novartis

OOS in Sterility Testing
Regulatory Requirements
Immediate Measures and Root Cause Analysis
Deviation Report
CAPA
speaker to be named

Pharmaceutical Water Qualities – Handling of OOS/OOL Results
Definition of OOS and OOL
Regulatory requirements
Assessment and root cause analysis
Alert levels and trending
Dr Wolfgang Eder, Roche Diagnostics

Dealing with OOS results in endotoxin testing
Definition of OOS and OOL
What is an OOS result
The previous “FDA Guideline” approach
Our current approach
Roles and responsibilities
Analytical and technical investigations
Decision making process
Retest/Re-analysis/Resampling
Conclusions and remarks
Dr Guy Roehrig, Lilly

OOS and objectionable microorganisms in non-sterile drug products
Important points to consider when performing root cause investigations
Objectionable microorganisms: risk assessment and origins of contamination
Examples of real cases
Dr David Roesti, Novartis

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