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Changes to EU GMP requirements for APIs

12/7/2010

Following its adoption by the European Commission on 31st January 2010, the updated European guideline on GMP requirements for active substances will become effective on 31st July 2010.  The principal change concerns enhanced provision for Quality Risk Management (QRM) and follows the notion that GMP requirements for active substances are falling under the scrutiny of increasing regulation.  For many, achieving confidence in compliance with GMP for active substances can be challenging, especially for finished product manufacturers who have busy QPs or whose products contain the more ‘atypical’ kind of active.  Whether you are looking for assistance with an audit or would simply like to seek the expert guidance of GMP advisors, we’re ready to help.  Call +44 1628 530554 or E-mail admin@wainwrightassociates.co.uk.