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Brief
The inspection of H2 PHARMA's establishment at Bois d'Arcy, Yvelines, from May 27 to 31, 2024, revealed significant non-conformities and shortcomings. Notified to the establishment in an injunctive letter on August 2, 2024, these issues persisted despite subsequent responses. The main purpose of this action is to enforce compliance with health and safety regulations. The non-conformities and shortcomings identified impact the quality and integrity of data management and risk control within the pharmaceutical industry. Compliance considerations include implementing a plan for equipment qualification and validation, ensuring the protection of data integrity through proper system organization and qualification, and assessing and managing cross-contamination risks.
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