GMP NEWS 2014

The USP plans the modernisation of many outdated and obsolete monographs. In the future, those monographs should contain uniform SST-requirements. A recent article published in the Pharmacopeial Forum describes the coming expectations of USP's experts group towards the parameters and acceptance criteria for chromatographic procedures. Read more in the News.

During her visit in India, FDA Commissioner Margaret A. Hamburg stated that inspections in India will be increased. Read more.

On Japan's Pharmaceuticals and Medical Devices Agency (PMDA) website, you can download documents on GMP as well as on marketing authorisations for medicinal products. An English version of the Japanese Pharmacopoeia (JP) is also available. You will find the direct links in the News.

The FDA has published a new Guidance on the validation of analytical methods which shall replace the 14 years old existing Guideline on the topic. More details about the contents of this highly topical document can be found here.

On 31 January 2014 the PIC/S Committee has adopted  the revision of the PIC/S GMP Guide (PE 009-11). The revised GMP Guide will enter into force on 1 March 2014. Find here more details.

The European Commission has launched the long expected draft of the revised Annex 15 (Qualification and Validation) for public consultation (see our news from 12 February). with a new chapter on verification of transportation. Read more.

The verification of data integrity has been required by the FDA for a long time now - for example through the performance of FDA pre-approval inspections. UK's MHRA has now communicated that it expects from pharmaceutical manufacturers as of 2014 to review data integrity in the context of self-inspections. More information can be found here.

In reviewing FDA's Warning Letters from the calendar year 2013, it has been found that 9 Warning Letters contained observations with reagrd to GMP/FDA complaint handling of OOS results. As a matter of fact, the handling of OOS results remains one of the most critical aspects during an FDA inspection. The most important citations from the Warning Letters can be found in this News.

Many pharmaceutical companies would like to achieve a so-called "FDA Readiness". But what should be understood under this term? Read more here.