Science v. Standardization: Meeting auditor’s expectations by understanding the reasoning behind the rules

Annex 1 requires designing an effective contamination control strategy based on a scientific assessment to understand the process and to apply risk management principles. The latest Annex 1 frequently uses the terms “risk” “justify” and “strategy”, underlying the importance of these concepts.

Paola Lazzeri discusses relevant Annex 1 areas (4.1, 4.32, 9.6, 9.21, 9.24, 9.29, 9.33, 9.38, 9.45), providing insights and highlighting important considerations when creating a contamination control strategy.