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More and more frequently, FDA inspectors find fundamental GMP deficits at facilities producing finished medicinal products. The following analysis of recent warning letters shows that the final testing of pharmaceutical products for compliance with the specifications can not always be taken for granted.

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The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

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Data governance and integrity have been getting more and more in the focus of regulatory inspections. But companies can prepare for these inspections. Find out how planned and periodic internal audits can help companies to prepare for regulatory inspections.

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Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.

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The China Food and Drug Administration has published the "Annual Report of Drug Inspection 2016" summarising CFDA's last year's inspection results.

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EU/EEA inspectors performed almost 2.300 GMP inspections last year. In these inspections they found an increasing number of Non-Compliance Statements.

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An Indian drug manufacturing facility receives a Warning Letter and an Import Alert because FDA investigators were detained from doing their job properly.

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The British MHRA has published the 2016 GMP inspection deficiency data trend. The report lists interesting examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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The new MRA Agreement between the EU and the USA on the mutual recognition of GMP inspections is being discussed in depth. One shouldn't conclude though that the inspection pressure would decrease now because of the recognition of EU inspections. Read more about the consequences of the GMP Inspection Agreement.

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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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