A report on last year's 21st APIC Conference on Active Pharmaceutical Ingredients. The event is the most important forum for manufacturers of active pharmaceutical ingredients and the pharmaceutical industry. Please read more here
Anyone who believes that the biggest changes and upheavals in the GMP environment are through may be mistaken. Not only due to the current political impassability, such as the Brexit, things are in motion. Please read more here
On 06-07 June 2019, the 8th European GMP Conference will take place in Heidelberg, Germany. This time, the Conference is also an opportunity for celebration - the ECA celebrates their 20th birthday at Heidelberg Castle. Please read more here
Good Distribution Practice (GDP) Guidelines and Good Manufacturing Practice (GMP) Guidelines require organisations to implement effective Corrective Action and Preventive Action (CAPA) systems. Please read more here
One of the most discussed GMP topics in drug manufacturing is documentation. This article explains how several aspects of documentation are to be handled and discusses new PIC/S specifications. Please read more here
When Novartis's valsartan drug patent approached its end, a market worth several billions of US Dollars was to open its doors. Therefore other manufacturers of generic active pharmaceutical ingredients (API) were racing to develop their own synthesis processes of the substance - which may be an explanation for the contamination. Please read more here
The revision of the EU GMP Annex 1 for the manufacture of sterile medicinal products and its consequences for the pharma production and technology is currently among the most discussed topics in industry. This topic also determined discussions of the more than 60 speakers from the pharmaceutical industry and from authorities and the 1.000 participants who convened at this year's Pharma Congress end of April in Düsseldorf again to discuss the latest GMP/FDA trends. Please read more here
Last December the European Commission published the draft version of the update of the EU GMP Annex 1. This draft, which is roughly three times longer than the current version, was open for comments until end of March. At the Annex 1 Conference end of May 15 speakers and 200 participants subjected the draft a thorough analysis. Please read more here
