MDSAP AU P0002.008: Audit Approach Key Changes in Latest Update

The Audit Approach for the MDSAP has been updated, key changes include:

🔹 Australia's Assessment Technical Documentation and agreements between sponsors and manufacturers now have more detailed requirements.

🔹 Design output requirements for Technical Documentation and Design History File (DHF) have been updated.

🔹 Auditors are now required to search for evidence of the inclusion of feedback into risk management, covering both products and processes.

🔹 The requirements for Non-conformance (NC) grading in sterilization processes have been clarified​​.

🔗 Original Document:  https://www.fda.gov/media/166672/download