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GAP Assessment Strategy for the New Annex 1

‐ Dec 12, 2023 12:00pm

This presentation will be focusing on the assessment strategy for the review and implementation of the new requirements of EU- GMP Annex 1. It will be based on the experiences of Boehringer-Ingelheim GAP assessment strategy, as a practical approach, considering how to address changes in current regulation as a multidisciplinary task, involving all areas with impact in the manufacturing of sterile products and how it has been addressed for new facilities and existing legacy facilities. It will also include GAPs evaluation, classification strategy and remediation activities and how their implementation has been addressed. For a better understanding of the new requirements of EU- GMP Annex 1 and in order to align its implementation, the GAP assessment has been addressed at a global level for all Boehringer-Ingelheim sites impacted.