Meet us at the 2010 PDA/ FDA Joint Regulatory Conference which will take place September 13-15 in Washington D.C. This year's conference theme is "The new Paradigm: Quality and Compliance in Merging and Emerging Cultures".

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) published four newly released Guidelines that were signed in Tallinn, Estonia, June 5-10, 2010. The Documents are now available on the ICH website.

Revised part II of EU GMP Guideline "Basic Requirements for Active Substances used as Starting Materials" will come into operation by July 31, 2010.

The European Commission has published the revised annexes 6 and 13 of the EU GMP Guideline some months ago. They come into operation on  July 31, 2010.

New GMP information about ICH meeting in Tallinn describes recent developments for the pharmaceutical industry.

On June 22, 2010 PIC/S announced that they have been invited by the European Commission to participate in an initiative for enhanced international co-operation in the field of APIs.

The PIC/S Committee met in Geneva (Switzerland) on 19-20 May 2010.

"When validating a manufacturing process, if a common bulk is used to manufacture a series of products, how should the pilot batch size be decided upon?" The answer to this question is provided by EMAs Quality Work Party in their Questions & Answers List.