News

PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems

11.04.2012

The PIC/S has recently published an Aide-Memoire for GMP inspectors on inspections of quality risk management (QRM) systems that became effective on 2 April 2012. Read more here.

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International Collaboration on Good Manufacturing Practice Inspections expanded

04.04.2012

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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Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration

14.03.2012

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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New Version of ISO 19011 on Auditing published

12.01.2012

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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New FDA and EMA Initiative allows mutual Recognition of Inspections

21.12.2011

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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International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

02.11.2011

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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Summary of FDA 483 Inspectional Observations

20.10.2011

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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Official Tips for preparing an initial Drug GMP Inspection

24.08.2011

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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Final Report on the International API Inspection Programme published

17.08.2011

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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EMA publishes Compilation of Community Procedures on Inspections and Exchange of Information

03.08.2011

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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