The European Medicines Agency (EMA) evaluated an additional use for guidance relating to non-clinical evaluation of radiopharmaceuticals and published a new concept paper on the development of such a guidance.
The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. Read more on the securPharm press release.
Since 1 November, the MRA has been in the operational phase. The FDA now recognizes EU inspectorates in 8 of 28 countries - the majority of countries is not yet recognized.
Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.
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 trade press has extensively covered the counterfeit of Harvoni, a pharmaceutical produced by Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here. Read more about the counterfeit case and the GDP consequences.
In a recent warning letter issued to "Wuxi Medical Instrument Factory", the FDA criticised deficiencies concerning process validation, amongst other things.
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 "Emerging Technology Applications for Pharmaceutical Innovation and Modernization" Guidance was already published as a draft in December 2015. Now the final Guidance is available.