GMP News - Inspections/Audits


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

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.



International Collaboration on Good Manufacturing Practice Inspections expanded

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.



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

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.



New Version of ISO 19011 on Auditing published

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.



New FDA and EMA Initiative allows mutual Recognition of Inspections

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.



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

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.



Summary of FDA 483 Inspectional Observations

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.



Official Tips for preparing an initial Drug GMP Inspection

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



Final Report on the International API Inspection Programme published

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.



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

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.



How compliant is your supplier? FDA establishes new Online Inspection Database

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.



Risk Management Principles used for WHO Inspections of API facilities

The new WHO Pharmaceutical Newsletter reports about the API inspection programme. This programme has been established by using risk management principles. Please read more here



New Compilation of Community Procedures on Inspections and Exchange of Information

EMA has updated the Compilation of Community Procedures on Inspections and Exchange of Information, a tool for facilitating co-operation between the GMP inspectorates of the EU Member States. Read more.



Inspection of API manufacturers: First Results of the WHO Pre-Qualification Programme

Within the framework of its pre-qualification programme of APIs, the WHO has published detailed results about the inspections performed at API manufacturing sites. Information about the GMP deviations found as well as further interesting facts can be found here.



DMA Document on Expectations for Audits of API Manufacturers

The Danish Medicines Agency (DMA) has published a document entitled: The Danish Medicines Agency's expectations for audits of API manufacturers. The DMA defined a number of expectations which need to be fulfilled if the QP delegates the task to a third party.  Read more here.


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