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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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In November, 2014, we had reported about the FDA guideline "Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". This guideline determines how the FDA handles companies that delay, restrict or refuse an inspection or deny access to individual rooms respectively refuse the entire inspection. A current Warning Letter demonstrates the significance of this guideline.

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An inadequate access control to the data processing of analytical chromatographic system means in all cases that data can be manipulated. A Warning Letter recently published gives an impressive example of insufficient data integrity in the area of quality control.

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From September 26 to September 29 the US FDA published four Warning Letters. One company is located in China and the other three are based in Europe. Read more about the four FDA Warning Letters

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The U.K. MHRA has published a blog and gives some insight in an audit performed as part of the Joint Audit Programme (JAP) for EEA GMP Inspectorates.

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It has been a hot inspection summer. FDA Warning Letters and EU Non-Compliance Reports seem to increase at the moment. It is worrying that the GMP non-compliance issues apparently get more serious than in the past. But what is the reason for the increasing GMP non-compliances?

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EudraGMDP is the European Database for GMP and GDP Compliance information. The database receives a lot of attention from industry because of the GMP and GDP Non-Compliance Reports. Now, the database has been changed without notice and has caused some confusion. Read more about the updated EudraGMDP Database.

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