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The ongoing collaboration on good manufacturing practice (GMP) inspections of active substance manufacturers between the European Medicines Agency and its international partners is to be expanded. Read more.

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The international programme on cooperation on GMP inspections of API manufacturers by regulatory authorities should be continued and extended. The EMA has published a document which defines the rules for collaborations and information sharing between the authorities. Read more here.

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ISO has published an updated edition of the ISO 19011 auditing standard. ISO 19011:2011 provides guidance on the conduct of internal or external management system audits, as well as on the management of audit programmes. You will find more information here.

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A new EMA/FDA initiative should enable the authorities in the European Economic Area (EEA) and the US to rely on the results of inspections performed in each other's territories. Read more.

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As International Pharmaceutical Quality (IPQ) reports in its September issue, the growing information sharing around the globe has an increasing impact on the US Food & Drug Administration's (FDA)  inspection decision-making and activities. Read more.

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The U.S. Food and Drug Administration FDA is frequently publishing summaries of its inspection observations listed documented on an FDA Form 483. Read more.

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Health Canada provides a new pre-application package to assist organisations in preparing for an initial drug GMP inspection. Read more.

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In a press release the EMA announced the publication of a final report on the International API Inspection Programme. The report presents the results of a 2-year international collaboration between competent authorities from Europe, Australia, FDA and EDQM. Read more here.

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The European Medicines Agency (EMA) has published the new Compilation of Community Procedures on Inspections and Exchange of Information. Although primarily addressed to inspectorates, it is also an interesting document for those being inspected. Read more.

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On May 26, 2011 the U.S. Food and Drug Administration announced a new web portal on its inspection activities. A key element of this new web portal is a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification. Here you will find more.

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