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The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.
The webinar "Audit Trail Review" took place in February 2017 - with the goal to address the main elements of data integrity and audit trail reviews. During this webinar more than 50 questions were asked. As time did not allow to answer all of them, the webinar's speaker, Dr Wolfgang Schumacher, provided comprehensive answers later. Find out what questions regarding Audit Trail Review were asked and how they were answered.
Due to deficiencies in the design of the filling system as well as the testing for particulate matter, the FDA has issued a warning letter to an Italian manufacturer of sterile products in Rome. Read more about the deficiencies resulting in a Warning Letter.
The feedback to the public consultations on recommendations related to clinical trials is now available online. Read more about the comments to the four draft guidelines issued in June 2016 regarding clinical trials.
The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.