Anna Cluet
Anna Cluet

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

By Anna Cluet

Revised EU GMP Annex 1 requirements must be fulfilled by August 2023. Designed to protect and increase confidence in the sterility of these products, the new specifications are significant and wide-ranging, spanning the Quality system and the manufacturing process itself. Anna Cluet of Rephine discusses the practical specifics of designing and delivering a fit-for-purpose contamination control strategy.

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SOTA
SOTA

State-of-the-Art: Unpacking MDR’s Evolving Requirements

By Elisabeth Liljensten, Lina Burman, Mark Cabonce, M.S., DABT, Monica Grekula

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge.

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