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.
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.
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.
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 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.
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.
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.
