Submission Documentation for Sterilization Process Validation - A Comprehensive View of Content for an Approvable CMC Section 2012

Topics

• Recent changes in regulatory guidance
• Global regulatory guidance and other relevant sources for sterility assurance
• Differences in content for terminal sterilization versus aseptic processes
• Sterility assurance content for marketing applications
• Use of parametric release in lieu of sterility testing at release
• Expectations for requalification of sterile processes
• Validation documentation for microbial quality test methods
• Use of container closure integrity in lieu of sterility testing on stability
• Potential pitfalls due to insufficient sterility assurance documentation