Module 14: Design Development and Certification of Medical Devices
17/11/2023
Microbiological audits
Which documents does the NB review? • Controlled environment procedures and verification data
• Routine sterilisation procedures
• Sterilisation validation protocols • • Sterilisation validation data •
Including associated technical agreements and contracts
Including associated technical agreements and contracts
Masterclass: Lecture 11
The Organisation for Professionals in Regulatory Affairs
47
Microbiological audits
Which documents does the NB review? • Sterilisation validation data • Bioburden / bioburden recovery • Sterility, bacteriostasis / fungistasis •
Applicable load configurations / dosing maps / supporting data
• Packaging equipment qualifications and routine packaging procedures. • Training records • Sterile load release notes
Masterclass: Lecture 11
The Organisation for Professionals in Regulatory Affairs
48
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