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

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP < 71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

Why Should You Attend:

This training session will provide an understanding of the regulations guiding the sterility testing program and the process of conducting an effective, robust and compliant sterility test investigation for various types of sterile products. Attendees will gain an understanding of:

• The step by step investigational tool to apply when conducting sterility test failure investigation.
• How to delineate between a probable and an affirmative root cause using the recovered contaminant based on the investigational findings.
• Possible corrective and preventative actions and how to apply the results of the investigation (investigational findings) to other manufactured batches of products within the same cleanroom.
• Disposition of the manufactured batch of product with a failed sterility test result, regulatory guidelines associated with a retest of the affected batch and handling a sterility failure associated with a commercially distributed product under stability testing program.
• The content of a sterility test investigation form to provide robustness to an investigational process will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program.

Learning Objectives:

• Discuss the regulations guiding manufactured product sterility testing such as USP < 71> Sterility Testing and how to ensure adherence to program testing requirements.
• Step by step process in conducting sterility test failure investigation and what to look for during the entire investigation process.
• Discuss the role of contaminant as a key tool during investigational process such as microbial identification of contaminant and if it is important or not important - why or why not?
• Performing a product retest during a sterility failure investigation and how to apply corrective and preventative action based on the findings of a sterility failure investigation.
• How to disposition impacted products based on investigational findings while avoiding common mistakes during product disposition.
• Impact of sterility failure investigation for commercially distributed products under a stability testing program.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

This webinar will provide a great resource to personnel involved within the following departments in the pharmaceutical, biotechnology, diagnostics, drugs, cell therapy, biologics, raw material, excipients, chemicals and API suppliers, and medical device industries:

• Quality Control
• Sterility Assurance
• Manufacturing/Production
• Senior Management
• Raw Materials Tester
• Supplier Quality
• Regulatory Affairs
• Quality Assurance
• Compliance
• Design Engineers
• Facility, Maintenance and Engineering
• Contract Manufacturing Organizations (CMO)
• Active Pharmaceutical Ingredients Suppliers
• Chemical Suppliers
• Excipient Suppliers