News

The "FDA Voice" is a Blog which has been developed by the US Agency to post current initiatives, presentation and views. In a recent post published on March 24, 2014 Howard Sklamberg and Cynthia Schedar discuss ideas to improve the quality of inspections. Read more about the new FDA inspection appraoch.

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The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. These documents are intended to help MHRA to get information prior to an inspection. Please read more about the MHRA risk ranking and the required Reports.

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Information about manufacturing sites that are out of GMP compliance is urgently needed. In a globalized world manufacturing is no longer located in the market where the medicinal products are sold. Health Canada is the next authority which reacts on the need for information to identify companies and sites that do not meet GMP standards. Read more about the GMP Inspection Tracker.

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A large part of the Warning Letters sent by the FDA in fiscal year 2014 was addressed to "compounding pharmacies". Against this background, the statistics of the most frequent deviations highlight other focuses. Read more here.

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The US Food and Drug Administration has initiated a comprehensive new organisation of their inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. Please read more about Quality Metrics in this GMP News.

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Supplier Qualification is a hot topic in inspections. Some examples of observations were published recently by the U.K. authority MHRA. Read more.

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The European Database on GMP and GDP Inspections (EudraGMDP) provides a read-only access for industry. The database is a very useful tool to monitor compliance of suppliers and contract partners. It also contains information about inspection findings. Read more about the latest entries to EudraGMDP.

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Deviations and CAPA remain hot topics in inspections, as a new MHRA report shows. Read more.

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Some companies delay or deny an inspection or even refuse the inspector to enter. A new FDA Guidance descibes what FDA can do when dealing with uncooperative companies. Read more.

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The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.

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