Regulatory requirements are changing faster and faster, and they are becoming more and more complex. That's why personal contacts and the direct communication between industry and authorities are gaining in importance. It is the only way both are pulling together and to create some "harmonisation" - not only on the regulatory level. Please read more here

The visual inspection of parenterals has been an intensively discussed subject for a while already. Now the EU GMP Guide Annex 1 is in revision, and the USP issued the long-awaited first draft of the chapter <1790>. Do they help to clarify what's still being discussed controversely? Please read more here

The continuously changing production landscape, the large number of production sites outside the US, medicinal product shortages are all among the factors that let the US FDA change their view: in future the authority will rely more on a quality culture much rather than merely inspect compliance with regulations. For that purpose the authority will be re-structured. Please read more here

The USP Dosage Forms Expert Committee has developed both new and revised general chapters that provide guidance on particulate matter content of injectable drug products. Please read more here