GMP News - Inspections/Audits


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?



Non Compliance Report in Radiopharmaceutical Manufacturing

The Italian Medicines Agency published a "Non-Compliance Report" on radiopharmaceutical manufacturing and a suspension of the manufacturing authorisation.



Has GMP Inspection Report of Slovenian GMP Inspectors caused FDA and Health Canada Import Alerts?

In March 2015 the Slovenian GMP Inspectors have conducted a GMP Inspection at the company Polydrug Laboratories PYT. LTD. in Maharashtra, India. Now it seems that both Health Canada and the US FDA have used the GMP inspection report of the Slovenian Authority to decide on consequences for supplies to Canada and the US. Read more about the compliance actions taken against Polydrug.



WHO issues GMP Non Compliance Statement to India based Svizera Labs

After FDA and EU have raised concerns about Good Manufacturing Practice implementation at a number of Indian companies, now the Word Health Organisation (WHO) also found serious GMP deviations. The company Svizera Labs located in Mumbai, India, received a Notice of Concern - a letter similar to the FDA Warning Letters. Read more about the WHO Letter of Concern to Svizera Labs


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