Strong controls needed for extractables and leachables says MHRA

The Medicine and Healthcare products Regulatory Agency has underscored the need for strong controls around extractables and leachables in pharmaceutical development.

Dr Melaine Pires, senior pharmaceutical assessor at the MHRA, outlined existing regulatory  guidelines to delegates at the Disposable Solutions for Biomanufacturing Conference in Munich, Germany.
Risks surrounding extractables and leachables included interfering with drug efficacy.
As such, Dr Pires said discussions were underway to harmonise legislation in key drug development regions around the world.

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Phill Allen

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An in and outside the (bioprocess) box thinker, fluid management specialist Phill knows a thing or two about keeping pharma liquid logistics flowing.

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