GMP News - Inspections/Audits


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.



Comprehensive Data Manipulation: New FDA Warning Letter for European Medicinal Product Manufacturer

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.



FDA publishes Four Warning Letters in one week

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



Who inspects the Inspectors?

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.



Is Cost Pressure becoming the Main Reason for GMP Non-Compliance and Drug Shortages?

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?



Confused about the changes in EudraGMDP?

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.



FDA Warning Letter to pharmaceutical manufacturer in Taiwan who owns ISO Certificates

Asia has been in the centre of attention when it comes to GMP non-compliance. This time the company KO DA Pharmaceuticals Co has been inspected by FDA and received a Warning Letter. Read more about the FDA Warning Letter here.



EU issues Non-Compliance Reports for US Company

EU Non-Compliance Reports for two sites of a US based company have been published leading to a withdrawal of the GMP Certificate and a stop of supplies into the EU.



TTIP: The End of FDA Inspections in Europe?

Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.



EMA Inspections increased by 35%

The number of GMP inspections increased by 35% in 2015, according to the 2015 Annual Report of the European Medicines Agency EMA, which was recently published.



GMP/GDP: When will I be inspected by the Authorities?

Various competent authorities are performing inspections. But who is subject to such an inspection?



Already 13 EMA GMP Non-compliance Reports in 2016 published

EudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. Please get the details about the GMP non-compliance findings at 11 manufacturers in Europe and abroad.



What are the 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 qualifying suppliers?


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