2019 - Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

Module#1 (Requirements of a Sterility Testing Program and Initial Consideration during a Sterility Failure Investigation)
Regulations Guiding Manufactured Product Sterility Testing
USP <71> Sterility Testing
Ensuring Adherence to Program Testing Requirements
Aseptic Processing
Contamination Control
Appropriateness of Testing Facility
Appropriateness of Testing Personnel
Training/Competencies
Initial Considerations During a Sterility Test failure Investigation
Affected Departments and Roles
Role of Quality Control
Role of Quality Assurance
Role of Manufacturing or Operations
Role of Facility or Engineering
Role of Regulatory Affairs
The Sterility Failure Notification Process
Initial Documentation Process during an Investigation
What Happens to the Affected Product Batch
Handling Affected Batch (or Batches) of the Product
Module#2 (Step by Step Process of Conducting an Effective, Robust and Compliant Sterility Test Failure Investigation)
Step by Step Process In Conducting Sterility Test Failure Investigation
What to Look for During the Investigational Process
Role of Personnel Handling and Cleanroom Behavior
Role of Testing Materials, Equipment and Media
Role of Environmental Monitoring or Testing
Role of Disinfection and Practices
Role of Testing Facility
Role of Laboratory Environment (Incubation)
Role of Training
Role of Environmental Controls
Role of Classified Testing Locations
Role of Room and Materials Qualification (Various)
Role or Microbial Identification
Role of Previous Product Sterility Test Failure Trends and Reports
Role of Previous Trends and Reports
Other Important Aspects
Role of Contaminant as a Key Tool During Investigational Process
Microbial Identification of Contaminant
Important or Not Important? Why or Why Not
Using a Process Map of Contaminant as a Tool for Root Cause Analysis
How to Utilize Identified Contaminant to Perform a Sterility Test Failure Investigation
Root Cause Analysis Process
Most Probable Root Cause versus Final Root Cause
Module#3 (Effective a Robust Corrective Actions, Preventative Actions, Sample of Investigation Forms, Product Disposition Process and Avoiding Common Mistakes)
Sample of Sterility Failure Investigation Forms
Important Sections
Effective Investigational Tools
Performing a Product Retest During a Sterility Failure Investigation
Regulatory Requirements Applicable to Product Retest
When to Perform a Product Retest
When not to Perform a Product Retest
Applying Corrective and Preventative Action Based on Findings of a Sterility Failure Investigation
Appropriateness of the Corrective Action
Appropriateness of the Preventative Action
Examples of Corrective And Preventative Actions
Disposition of the Products Based on Investigational Findings
How to Determine a False Positive Result
Dispositioning Products After a Sterility Failure Investigation
Avoiding Common Mistakes During Product Disposition
Role of QA
What Happens After Product Disposition
Impact of Sterility Failure for Commercially Distributed Products under a Stability Testing Program
Commercial Impact-Product Out in the Market
What Happens Next if a True Contamination or Failure is Discovered
Role of Regulatory Affairs
Agency Notification Process
Avoiding Common Mistakes During
When not to Ignore - An Early Warning Sign of a Systemic Issue
When not to Ignore - An Effective Implementation of Adequate Corrective Action and Preventative Action