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.
Topics in this paper include:
- Monitoring Requirements
- Viable Monitoring
- Method Validation
- Audits and Risk Assessment
- Cleaning and Sanitization
- Applications
Some questions covered in this paper are
- Do “clean material” rooms need grade classification and require monitoring?
- What is the recommended number of particle probe ports, and the height and distance from the filling needles in a filling machine under oRABs?
- For incoming goods, what is effective against spores?
- Do plate agars simulate a normal surface in which a vial microorganism could sediment on?
- What are other techniques for performing a risk assessment?
- How would you test compressed gases from a cleanroom?
- …and many more!
