GMP NEWS 2014

On 28 March 2014 the European Commission has published a new question and answers document which will clarify some frequent asked questions about the interpreation of the new EU GDP Guideline. Please read more about the EU GDP Q&A Document

The planned revision of Annex 15 doesn't provide for a periodic revalidation any more. Can it therefore be dropped in the future? The following is an overview of the actual requirements concerning the periodic revalidation or its possible cancellation.

The so called Food and Drug Administration Safety and Innovation Act (FDASIA) requires the FDA to publish reports on the inspection of registered establishments every year starting with the fiscal year 2013. The first Annual Report is available now. Read more about the Annual Inspections Report.

At the end of December 2013, the USP published the latest stand of its "General Notices and Requirements". Here, the date for the coming into force of the chapter on elemental impurities has been postponed to December 2015. The section on temperature reading devices has been updated, too. Read more in the News.

On 6 March, the CBER published a new guideline for Industry as well as for FDA staff related to the Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood.

A new era has begun with the publication of the draft on the revision of Annex 15 (Validation/ Qualification) with regard to validation. The volume has grown from 11 to 17 pages. A few new chapters have been added, whereas much familiar information is missing. You will find a detailed analysis in the News.

The EU GMP Guide Annex 15 was originally published in 2001. At the end of October 2012, the EU has announced to revise it. Now the draft for the revision of Annex 15 is published. All in all there is an abundance of new requirements. Some new terms ar a bit "nebulous" and the whole document seems to be a little "spongy". Therefore, the ECA has set up a survey to get a feedback from the pharmaceutical industry. A summary of the feedback will be forwarded to the EU Commission and will also be published as news. Read more.

It didn't really come as a surprise that EMA published its revised Guideline on Process Validation on 27 February 2014 after the publication of the draft on the revision of Annex 15 at the beginning of February. EMA had announced the revision in a concept paper already a long time ago. Read in the following a detailed analysis of the Guideline on Process Validation.

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. What's new?