GMP News - Inspections/Audits


Chinese FDA is performing more international Inspections

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



More Non-Compliance Statements issued by EMA

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



FDA Import Alert for inadequate Inspection Management

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



New Analysis of GMP Inspections by MHRA

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.



EU GMP Non-Compliance Report might lead to FDA Import Stop in future

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.



USA and EU adopt Mutual Recognition Agreement - Does it mean the End of FDA Inspections in Europe?

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.



What are the current Rules for Supplier Qualification?

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?



First Warning Letter Citation of new FDA Guideline on Contracts

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.



Inspection Findings in Supplier Qualification and Contracting

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



What are the current GMP Inspection Initiatives?

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.



Interesting Analysis of GMP Inspections published

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.



Warning Letter and Import Alert for Chinese Manufacturer

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.



End of TTIP? What about the MRA with FDA?

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.



Serious Violations of GMP and Obstruction to an Inspection: FDA Warning Letter for a Chinese API Manufacturer

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.



Unusual Warning Letter published by the FDA

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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