Joint API inspection pilot proves successful

Over recent years compliance with GMP in the manufacture of active substances (APIs) has been the subject of increasing regulatory interest. In May we reported that the consultation period for the European Medicines Agency’s (EMA’s) proposed template and associated Q&A document for GMP declarations in relation to active substances had ended and we advised applicants to plan accordingly. Of further note, the EMA and its international partners have also now published information about their positive experience in the pilot programmes which are part of the international collaboration concerning GMP inspections of active substance manufacturers. If you have any questions about GMP requirements or require a mock audit, we have a highly experienced team of GMP advisors and auditors. Contact us to discuss your requirements; email enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554 For more information visit www.wainwrightassociates.co.uk