New PIC/S tool helps decide frequency, scope of routine pharma GMP inspections
This article was originally published in SRA
The executive committee of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) has announced the availability of a new "quality risk management tool" that PIC/S member countries can use to plan the frequency and scope of their good manufacturing practice inspections1,2.
You may also be interested in...
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
As part of its big data initiative, the European Medicines Agency is supporting projects that will help identify appropriate real-world data sources for regulatory decision making.
The European Medicines Agency may decide this week on a dozen requests by companies seeking new uses of their approved drugs.