Based on a survey, the EFPIA has published a highly interesting position paper. It describes the problem represented by the continually increasing number of international authority inspections. Read more about the possibilities for improving the situation.
Quality by Design can be of relevance to manufacturers of pharmaceutical excipients, since excipients can have an important influence on the properties of the product and on the production processes. The IPEC Europe has issued a Q&A document on this topic. Read more here.
The responsible personnel for disinfection management is often uncertain whether national or international standards of disinfection testing will be the rigth base to evaluate the capability of chemical disinfectants. Read more.
With the key target of ensuring appropriate clinical trials, EMEA and FDA have launched a joint initiative. What is to be ensured among other things is the further harmonisation of clinical trials for obtaining marketing authorisations in Europe and the USA. Read more here.
"ICH Q4B Annex 8 to Note for evaluation and recommendation of pharmacopoeial texts for use in ICH regions on sterility test general chapter" is in Step 4 now, and the proposed text has been submitted to the Pharmacopoeial Discussion Group (PDG). Find out more.
Decay period and abration, sterility testing and Polyacrylamide Gel Electrophoresis are the topics of four new ICH Q4B Annexes the European Medicines Agency (EMEA) issued end of June. Read the details here.
Cleaning validation has been a very important topic for the pharmaceutical industry since the 1980s. On the Internet portal Scribd, a presentation on this subject has been published that illustrates the topic quite clearly. Read more.
Following the launch of a new version the EudraGMP database is now providing public access to information about manufacturing, importation authorisations and Good Manufacturing Practice (GMP) certificates. Find more information here.
The European Medicines Agency (EMEA) published a note for guidance about ICH Topic E16 Genomic Biomarkers Related to Drug Response, open for comment until September 2009. To find out more please read here.
The FDA publishes the revision of a guideline on impurities in generic medicinal products. The document calls for the indication of detailed information on impurities stemming from the active pharmaceutical ingredient (API) when a new application for a marketing authorisation for a generic is submitted or when a supplement is submitted because of changes to the API manufacturing process. The provisions of the guideline also apply to Type II Drug Master Files. Read the details here.
A large number of comments on the two detailed guidelines about the different variations categories and procedural questions regarding variations to the terms of marketing authorisations were submitted by industrial associations, authorities of EU member states, and companies. The European Commission has published all these statements as well as a summary and evaluation on its website. Here you can read more.