PTI - international

• Review cGMP requirements related to laboratory controls
• Establish a strong metrology program for maintenance and calibration of equipment
• Maintain stability chambers in a validated state
• Self-audit laboratory activities to prepare for FDA inspection
• Prepare employees to effectively communicate with FDA investigators
• Implement metrics to monitor activities and allocate resources to avoid pitfalls

Exercise: Examine Recent FDA Warning Letters to Identify Common Trigger Points

VII. Stability Test Methods

• Review regulatory requirements related to stability test methods
• Design and evaluate forced degradation studies
• Validate test methods based upon development phase
• Assess robustness of HPLC methods
• Implement effective change control procedures

Exercise: Analyze Hypothetical Scenarios and Determine Re-Validation Strategies

VIII. Out-Of-Specification (OOS) Stability Test Results

• Define various types of failures (out-of spec, out-of-limit, out-of-alert, out-of-trend)
• Review regulatory requirements related to OOS investigations
• Outline a process for OOS investigations
• Clarify roles and responsibilities of parties involved in OOS investigations
• Highlight the #1 cause of OOS and the #1 corrective action
• Utilize data trending techniques

IX. Documentation and CMC Submissions

• Maintain clear and concise records related to stability testing
• Standardize documentation to facilitate FDA inspection
• Satisfy regulatory requirements and allow the laboratory to be managed efficiently
• Develop stability section of CMC submissions
• Include accurate, detailed information based upon development phase

Exercise: Compare Proper and Improper Lab Documentation
Discussion:  Discuss Real-Life Examples of CMC-Related Issues

X. Stability Program Infrastructure

• Build the necessary infrastructure to support an effective stability program
• Streamline processes and save resources
• Develop a Stability Review Board (SRB) and a stability review process
• Determine when and how to outsource stability testing
• Establish metrics

Discussion: Discuss Specific Stability Projects to Champion Upon Return to Job