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
Last November European API manufacturers and regulating authorities met in Venice, Italy, to discuss current GMP topics and regulatory issues. The openness on both sides clearly contributed to a further mutual understanding. Please read more here
Once every year Qualified Persons (QP) and other interested professionals from all over Europe meet to discuss the burning issues in their daily business. Today, the QP Forum is the central meeting point. Please read more here
One of the reasons for substandard APIs finding their way into medicinal products certainly is today's globalised and fragmented supply chain. However, the awareness for safety gaps as well as the efforts to close these gaps are increasing on both sides at authorities and in the industry. Please read more here