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The formation or flakes of glass particles on the inside of glass containers is referred to as delamination. These glass fragments, created by the interaction of the solution with the container walls, can pose a risk, especially when it comes to parenterals.
When an inspection unearths severe GMP violations, the FDA sometimes issues a ban on imports for the concerned products of a company. Read here what conflicts can arise when such an import alert concerns APIs of a Chinese manufacturer which were classified as prequalified in an inspection by the WHO beforehand.
The European Medicines Agency (EMA) recently posted on its website that the new EU Clinical Trial Regulation will come into application during 2019 instead of in October 2018, as previously announced. Read more about the new time schedule for application of the Clinical Trial Regulation EU No. 536/2014.
A new USP general Chapter that describes the basic principles and practices used in the characterization of tablet compression has been approved and published. Read more about the new USP chapter <1062> Tablet Compression Characterization.