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.
ECA's Analytical Quality Control Group (AQCG) is currently drafting a comprehensive new Guideline on 'Analytical Procedure Lifecyle Management' (APLM) to support the lifecycle approach for analytical procedures. Find out more about this new and important APLM Guidance document and the related APLM Conference.
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.
The European Medicines Agency (EMA) recently released a draft Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development.
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 US Food & Drug Administration (FDA) published a deviation report for Biological Products and HCT/P for Fiscal Year 2016, comparing the results with the two years before.
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 European Medicines Agency, EMA, announced a new timeline in its press release dated 6 October 2017. According to this, the EU GCP Regulation will be applied mid-2019 at the earliest.
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.