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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