When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?
In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.
Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities.
There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.
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.
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.
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 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.
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.