The revised and recently published general chapter <1225> - Validation of Compendial Methods - in the first supplement of the USP 32 describes the requisite performance characteristics that should be considered to prove the validation of a method in the case of its submission to the Pharmacopoeia. Find more information here.
A new FDA guidance draft relative to "Genotoxic and Carcinogenic Impurities in Drug Substances and Products" makes recommendations for characterising these impurities and for the limits in connection with the development phases as well as for already authorised drugs. Get the details here.
The development of the European Compliance Academy (ECA) is a true success story - since its inception in 1999, the ECA has been experiencing a steady increase in awareness and interest and was able to accomplish many goals. This year, the organisation commemorates its 10 year anniversary. Read more in the ECA Annual Review.
The Center for Drug Evaluation and Research (CDER), the FDA center responsible for chemical drugs, protein drugs and monoclonal antibodies regularly publishes statistics for the respective fiscal year. Find more information on an interesting statistic concerning the GMP sector - here.
The new GMP Guideline Manager release 11.0 is now a web-based solution and thus does not require additional software to be installed. To find out more about the advantages the new release combines, please read here.
The ICH has decided to publish an official contact address to which everybody can send questions regarding the implementation of Q8, Q9 and Q10. These questions are then forwarded to the members of the working groups. Here you can read more.
The Annex to ICH Q8 Pharmaceutical Development reached Step 5 providing further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of Quality by Deign (QbD). Read more.
Within the framework of the Food and Drug Administration Act of 2007 (FDAAA), the FDA has published another draft guidance. Against the background of fighting counterfeit medicines, this paper gives introductory information on standardising the numerical identification of medicinal products. Read more.
The European Medicines Agency (EMEA) has published a comprehensive Q&A document on the preparation of applications for a PIP and/or waiver, eleven pages long, with answers to the following 21 questions.
The European Medicines Agency (EMEA) has set out its strategy in relation to the acceptance, as part of a marketing-authorisation application, of clinical trials conducted in third countries. Read more.