In the near future, extensive stability data on the medicinal product and the API should be submitted for the application of generics in the USA. The FDA has recently published a draft guideline for comment. More details about the new requirements can be found here.
The GDUFA (Generic Drug User Fee Act), the new fees regulation on generic drug applications, is valid in the USA as of 1 October 2012. One part of this legislative regulation is a completeness assessment of the Drug Master File, the generic drug application refers to. This has significant effect on the applicant. Go here for more information.
The European Compliance Academy developed a so-called Good Practice Guide some years ago. It is a juxtaposition containing the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. Read more here.
We are often consulted about the acceptance of GMP audits of API manufacturers. The point is that more and more organisations offer such audits. What is essential to pay attention to? More details can be found here.
Local Chinese authorities are currently investigating against a few renowned API manufacturers who are accused of having used waste oil from restaurants for the production of their antibiotics. China's largest API manufacturers are among the accused manufacturers. Read more.
In 2010 the European QP Association initiated the shared audits database "QPSHARE". With this database the Association wants to support European QPs in identifying suppliers other QPs are possibly interested in as well - and that way facilitates sharing audits. Read more.
In last week's news we talked about an ISPE Mapping Document that illustrates relationships to other ISPE Guides on qualification. One of these ISPE Guides, the ISPE Good Practice Guide "Applied Risk Management for Commissioning and Qualification" is used as bridge in order to connect traditional qualification approaches according to ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&Q) to a modern risk- and science-based qualification approach. Read more.
The US FDA emphasised again, that the application of Quality by Design will be mandatory for manufacturers of generic drugs from January 2013 and will be demanded. In the meantime the second FDA case study has become available. Read more.
FDA aids the pharmaceutical industry in developing generic drug products by providing a database on methods for active drug dissolution testing. The most important functions are described in the FDA document "Frequently Asked Questions". You can obtain more information in this news.
The PDA has issued an interesing document with a case study on the application of Quality by Design in the manufacture of vaccines. This document was developed by a cooperation of five pharmaceutical companies. Read more.
The EMA has published the European Union regulatory network incident management plan for medicines for human use, explaining how the EMA, the European Commission and medicines regulatory authorities work together in the EU Member States. Read more.
With the recommendation of the authorisation of Glybera, the European Medicines Agency (EMA) recommends the approval of a gene therapy product for the European Union market for the first time. Read more here.
The European Commission has published the final version of the revised Chapter 1 of the EU-GMP Guide, which will now be called "Pharmaceutical Quality System". The new Chapter 1 includes also refrence to IMPs and Pharmaceutical Development (read more).