October 2007 – New Draft Annex 2 (Manufacture of Biological Products) to the European GMP Guide Comments are invited on the new draft to the EC GMP Guide on medicinal gases by December 31st, 2007. This was necessary because of the …
September 2006 – Latest on Clinical Trials from the EMEA The final version of the EMEA Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials comes into operation on 1st October, 2006. …
November 2005 – Annex 18 to become Part II in the EU GMP Guide. EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Part II …
July 2004 – NEW ANNEX 19 From our EU correspondent A new Annex 19 (Reference Samples and Retention Samples) to the EU GMP Guide (Volume 4) was released for consultation on the Commission website. According to the Commission website, the new …
December 2003 – New Stability requirements Additional text “On going Stability” for Chapter 6 to the EU GMP Guide has been adopted by the Ad hoc GMP inspectors Working Group. The proposed text provides guidance on ongoing stability monitoring in line …
October 2002 – Purchase Copies of PS9000 and PS9100 Following the successful launch of PS9100 we have now generated a downloadable order form for each of the docuements. PS 9000 order form, PDF (125Kb) PS 9100 order form, PDF (125Kb) October 2002 – …