Steps to Ensuring a Successful Audit Frequently Asked Questions

This FAQ paper is a follow-up to the webinar, “Steps to Ensuring a Successful Audit: Effective Risk
Assessment Design”. Many thoughtful questions were asked about cleanroom design, control of
particles and microorganisms in pharmaceutical manufacturing and risk assessment methods.
Questions submitted during and after the webinar are answered below.

Questions answered fall under these categories:
• Monitoring Requirements
• Viable Monitoring
• Method Validation
• Audits and Risk Assessment
• Cleaning and Sanitization
• Applications