GMP NEWS 2017

The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.

The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of the facility in May and June 2017. Amongst other things, it criticised particle findings in released products, insufficient environmental monitoring and deficiencies in aseptic activities. Read more about the deficiencies found during the inspection.

The recall of already released batches, the withdrawal of the currently valid GMP certificate and the import ban for Europe are amongst the most notable consequences of an EU GMP inspection in India. The main focus was on faulty OOS management. Read this news for more information about the "Statement of Non-Compliance with GMP" for Dr. Reddy's Laboratories Ltd.

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.

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 European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.

In August, the FDA published a Draft Guidance for Industry on CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.

The European Directory for the Quality of Medicines and Healthcare Products (EDQM) published a guidance document on the handling and root-cause analysis of Non-Conformity results in quality assessments. 

The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. Read more about the changes in the Swiss Therapeutic Products Act.