Archives for January 22, 2013

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EC Updates Guidance to Ensure Supplier Compliance

By Zachary Brennan

The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.

EU Agrees to Joint GMP Audits with Israel, New Zealand

By Zachary Brennan

The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.

KTP adds string to Almac’s biocatalysis bow

By Dan Stanton

Almac says the completion of a Knowledge Transfer Partnership (KTP) has aided biocatalysis development offering clients an array of streamlined processes.