According to the latest EU report the number of counterfeit medicine packs seized when entering Europe in 2009 increased to 11,5 million - impressively illustrating the need for a harmonised European approach. But what does this mean for those involved in the manufacturing process or in the supply chain? Please read more here
The latest developments in the fight against counterfeit medicines were in the centre of attention at the ECA Conference "Strategies against Counterfeit Medicines" in Würzburg, Germany, last spring. Please read more here
In the past years the Bio Production Forum has been concentrating on taking a close look at the last stages of the development up to the production of biopharmaceutical products. As in the past years the conference this year again initiated the discussion of current regulatory developments and contributed to the understanding of the latest trends. Please read more here
What are the most important changes in the first revision of the chapter on testing non-sterile dosage forms and the proposed acceptance criteria and what do they actually mean? Please read more here
In April 2010 the Monocyte Activation Test (MAT ) for the proof of pyrogenic substances has been included in the European Pharmacopoeia. This opens the chance for enormous progress with regard to ensuring that pharmaceutical products are free of pyrogenicity. Please read more here
The most important of three legislative proposals for the GMP environment by the European Commission is Part 3, dealing with combating counterfeit medicines as well as illegal distribution of medicinal products. Please read more here
The Regulation on Medicinal Products for Paediatric Use has been effective since December 2006. And this regulation is mandatory for all pharmaceutical companies developing new products. Please read more here
The appropriate electronic system can not only help to better save and secure data but also to generate them automatically, integrate them into the batch record or even to control processes completely. Please read more here
The processes recommended in the new Guide require a new way of thinking - especially in the quality assurance units of pharmaceutical manufacturers. Please read more here
The requirements defined in the Annex 1 are still being discussed extensively. Now a PIC/S document may help companies to better interpret the requirements. Please read more here
