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In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.
The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.
Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.
Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.