News

The heads of the EU authorities for medicines are organised in a group called Heads of Medicines Agencies. In a meeting which took place in Dublin just recently, the Committee identified the need for GMP inspections to be conducted at API manufacturing sites by the 2nd of July 2013. Read more.

Many in the GMP environment haven't realised the consequences of the so-called Generic Drug User Fee Act (GDUFA) yet. The FDA has now published the exact fee rates for facility inspections. Read more here.

The European Compliance Academy developed a so-called Good Practice Guide some years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. Read more here.

We are often consulted about the acceptance of GMP audits of API manufacturers. The point is that more and more organisations offer such audits. What is essential to pay attention to? More details can be found here.