GMP News - Inspections/Audits


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.



FDA Inspections: Current Initiatives

The globalization of the pharmaceutical supply chain and the quality issues that have arisen because of that globalization, the FDA initiative "Pharmaceutical Quality for the 21st Century" and resource constraints that all Health Authorities are feeling are all changing the way FDA is viewing their mission to protect the American consumer.  Click here to get an overview about the current initiatives.



FDA Inspection Reports: What is what?

We are asked about the different inspection reports of the US-American health authority FDA (US Food and Drug Administration) again and again. In this newsletter, we would like to present the three most important documents to you. Read more.


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