GMP NEWS 2012

What are FDA's requirements regarding medical devices? The FDA itself gives a partial answer to this question. At the end of last year and at the beginning of this year, the FDA has been making an extensive update of its online training available on CDRH's (Center for Devices and Radiological Health) medical devices homepage. Read more here.

On 15 March 2012, the EMA published the long-awaited revision of the Process Validation Guideline. The finalised document will replace the current valid guideline entitled "Note for Guidance on Process Validation". Comments to the draft can be sent until 31 October 2012. Click here to read more.

According to the new version of EU GMP Annex 11 it is now a regulatory requirement to conduct periodic computerised systems evaluations. This is currently best practice in the GAMP Good Practice Guide for Maintaining Validation which already contains an appendix for conducting a periodic review. Read more here.

At a meeting on 30 March 2012, the participants involved in the SecurPharm project agreed on essential technical and organisational details to be implemented in the pilot project. This project will start in the beginning of 2013 in Germany. Read more in the News.

The term "Design Control" was originally used only in the development and manufacture of medical devices. In the meantime "Design Control" became an important issue for the development of pharmaceutical drug products just as well. There are more and more requirements and requests from the regulatory authorities relating to "Design Control" for Combination Products. For people working in the pharmaceutical industry it is a challenge to transfer all these new terms to their existing and traditional development processes. Read more.

The FDA published two documents on vaccines safety and the reporting of vaccine adverse events in the United States. More details can be found here.

What consequences has the new EU GMP Guideline Annex 11 "Computerised Systems" for the European healthcare industry? Questions and Answers by Inspectors and IT professionals provide you with first hand information - see here.

So far, chromatographic adjustments haven't been recommended by the USP for the use of gradients in the mobile phase for system suitability tests. In a revised draft for General Chapter <621>, major changes have been proposed in the Pharmacopeial Forum. Read more here.

The new GDP Guideline is intended to come into force in June/July 2012. The key function of the so called Responsible Person will be strengthened. Please read more here.