Online search App for GMP contents on Android Tablets or Smartphones created

Relevant GxP documents available at your fingertip – based upon this amazing idea, blue inspection body has created a first online search App for Android Tablets or Smartphones. The App is free of charge and provides an online search for GMP contents in guidelines, guidances, directives, Q&As etc. from authorities and organizations such as EMA, FDA, ICH PIC/S . . . 

Search results can be viewed and marked as favorites in order to be available also in the off-line mode on the device. With the feedback from users, further optimization is planned as well as creation of an iOS App for Apple products.

Current status concerning API imports into Europe after July 2nd, 2013 according to Art. 46b Directive 2001/83/ECs

With the USA having now requested to be included on the list of third countries waiving the need for a “written confirmation” the current status of the assessment and list is as follows: Switzerland(accepted), Israel (no listing for the moment, contacts ongoing) Australia, Brazil, Japan, Singapore, United States (assessment ongoing). The Euro-pean Commission has expressed its expectation, that Japan and potentially Australia will be included in the list before the July 2013 deadline. The position of India and China concerning the issuance of “written confirmations” is still uncertain. There are some hints, that both countries are active in coming to a solution (e.g. SFDA is collecting information from API makers about available EU GMP certificates). As a risk mitigation strategy, enhancing API stocks in Europe sourced from third countries before July 2013 is advisable.

Stricter regulations for Excipients in China ahead

The implementation of stricter regulations for the production and use of pharmaceutical excipients in China is foreseen for February 1st. However, further details such as a list of ‘high risk’ excipients or the related mandatory registration and approval procedure for these excipients are still lacking publication.

Major GxP Events I & II/2013