The ICH Steering Committee and its Expert Working Groups met in Belgium in June 2013. The Steering Committee agreed measures aimed at increased transparency in pursuit of greater harmonisation and will provide more detail to the public via the ICH website, including agendas and the reports of meetings as well as the work plans of…
The impact of recent changes to the “Internationally harmonised requirements for Batch Certification”? The European Union (EU) has reformed the rules for importing active pharmaceutical ingredients into the EU for medicinal products for human use. As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing…
It is not unusual for Pharmaceutical Quality Systems (PQS) to be perceived, as ‘expensive’ and ‘non-value adding,’ by some areas of a GMP organisation. Often managers with Lean or Six Sigma backgrounds struggle to make the correlation between GMP and process efficiencies. ICH Q10, PQS, is a guidance document first released for industry comment in…
This concept paper addresses the need to update Annex 17 (Parametric release) of the EU GMP Guide. At the time the original guideline was adopted (January 2002), the main foreseen application area was sterility testing, with a particular focus on the release of terminally sterilised medicinal products. Since then, there have been significant changes in…
Regulators from several APEC countries met in Taiwan in early November for the second workshop on Good Review Practices. This was an advanced workshop, following on from the initial meeting held in Taipei in October 2011. The workshop was jointly hosted by the Taiwanese FDA and the Center for Drug Evaluation, Chinese Taipei, and sponsored…
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