Strong controls needed for extractables and leachables says MHRA

posted by Phill Allen

February, 18th, 2015

Company News Pharmaceutical Industry News

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

TAGS: extractable, leachables, The Medicine and Healthcare products Regulatory Agency,

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Phill Allen

Managing Director

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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