GMP News - Inspections/Audits


FDA's new Quality Metrics Program to plan GMP Inspections

The US Food and Drug Administration has initiated a comprehensive new organisation of their inspection activities. One of the key elements of this initiative is the Quality Metrics Program. This program will throw a complete new light on the compliance status of each manufacturing site. Please read more about Quality Metrics in this GMP News.



Frequent Findings in Supplier Qualification

Supplier Qualification is a hot topic in inspections. Some examples of observations were published recently by the U.K. authority MHRA. Read more.



EMA publishes several GMP Non Compliance Reports

The European Database on GMP and GDP Inspections (EudraGMDP) provides a read-only access for industry. The database is a very useful tool to monitor compliance of suppliers and contract partners. It also contains information about inspection findings. Read more about the latest entries to EudraGMDP.



Managing CAPA and Investigation Processes still in the Focus of Inspectorates

Deviations and CAPA remain hot topics in inspections, as a new MHRA report shows. Read more.



New FDA Inspection Guidance gives the Agency more Power

Some companies delay or deny an inspection or even refuse the inspector to enter. A new FDA Guidance descibes what FDA can do when dealing with uncooperative companies. Read more.



Major Reorganisation at FDA will affect GMP Inspections

The US Food and Drug Administration has informed about a major reorganisation. The FDA has announced plans to introduce a new organisational structure which will become effective on January 2015. Read more about the FDA reorganisation



FDA's New Inspection Data Dashboard

The US FDA has recently introduced a new service on their webpage. A new "inspection dashboard" provides information and analysis about the inspections which have been performed by the FDA in the previous years. Read more in our GMP News.



EU GMP Inspectors find 26 GMP Deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals

EU GMP Inspectors from the competent authority in Romania identified several GMP deviations during a GMP inspection at a Chinese API manufacturer. As a consequence, a GMP Non-Compliance Report has been issued. Read more here about the GMP Non-Compliance Report.



New GMP Non-Compliance Reports available in EudraGMDP

Last month, new GMP Non-Compliance reports were issued for three pharmaceutical companies. The facilities concerned are located in India, Taiwan and Bulgaria. Read more about these new GMP Non-Compliance Reports.



Chinese Company Refuses GMP Inspection and Gets an Import Alert from the FDA

The US FDA has placed the Chinese company Beijing Shunxin Meihua Bio-technical Co on an import alert. Read more here about the FDA Import Alert.



Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare

Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Read more here about the FDA Warning Letter to Marck Biosciences and about the name change to Amanta Healthcare.



Serious GMP Violations found at Chinese API Manufacturer - Basic GMP principles not followed

On 7 July 2014 the US FDA has issued a Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co., Ltd. located in Taizhou, Zhejiang Province in China. The company is a producer of APIs and failed to establish basic GMP principles. Please read more about the FDA Warning Letter.



FDA 483s available in the World Wide Web

Besides Warning Letters, the U.S. Food and Drug Administration is also publishing other inspection documents. Read here where you can find them.



Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. Read more about this Warning Letter here



New GMP Non-Compliance Reports in EMA Database

There are some new entries about GMP and GDP non-compliances in EudraGMDP, the European Inspection Database. Please read this news to find out more about the GMP and GDP Non-Compliance Reports.


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