Magazine Article | March 1, 2023

Regulatory Update: CDMOs And Contamination Control Strategy

Source: Life Science Leader

By Ryan Murray and Amanda McFarland

With the August 2022 released revisions to Annex 1 of the EMA’s EudraLex Volume 1 and the increased expectations it brings to sterile drug producers, CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

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