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On 2nd March 2017, the US FDA and the EU (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Such agreements are intended to mutually recognize GMP inspection systems. As a consequence, the GMP Compliance of a site is reviewed by the respective inspection authority. Afterwards, the FDA can use EU inspection results and vice-versa. Read more about the FDA//EU MRA Agreement.

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The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. Read more about the FDA reorganisation

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Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements for supplier qualification?

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Despite TTIP's intermission, a possible agreement between the EMA and the US FDA on the mutual recognition on drug facility inspections is moving forward.

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During an FDA inspection of a Chinese drug manufacturer, the inspector criticized serious and sometimes even bizarre GMP violations  Read more about the Warning Letter to the Chinese Manufacturer Baoying County Fukang Medical Appliance Co. Ltd.

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After the Food & Drug Admininstration (FDA) published its final Quality Agreements Guidance end of last year, we now find the first citations in Warning Letters.

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Supplier Qualification and Contracts are a hot topic in inspections. Some detailed examples of observations were published recently by the U.K. authority MHRA.

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The ICMRA has published a very interesting overview about the current global GMP inspection initiatives by the competent authorities. It also shows the various initiatives between the EU and FDA.

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The British MHRA has published the 2015 GMP inspection deficiency data trend. The report lists examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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At companies where serious GMP violations are observed, a misconduct of the personnel can often be identified during the inspection. A Warning Letter issued to a Chinese API manufacturer describes attempts to obstruct the inspection as well as some typical violations of GMP with regard to data integrity.

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