GMP NEWS 2013

The European Commission has published the revised chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely. Read more.

ECA's working group Analytical Quality Control has developed a new general SOP on the handling of OOS results. This SOP was presented at the OOS Forum in Prague, the official launch conference for this SOP, in June 2012. At the Forum alternative approaches were discussed by representatives of industry and authority. The final ECA SOP came into force in August 2012. Get more information.

CDRH, the FDA department responsible, inter alia, for the regulation of medical devices, published a new draft guidance in mid-December 2012. The intention of the guidance... read more here.

On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide. The publication had been expected for a long time now. Read more here.

The General Notices section of the US-American pharmacopoeia USP-NF is to be revised. An article in the Pharmacopeial Forum makes concrete proposals. In the future, the focus will be more on the electronic version. More information is available in this News.

In its fatalities report on vaccines, blood and biologics the FDA states that "Overall, the number of transfusion related fatalities reported to the FDA remains small in comparison to the total number of transfusions. To find out more about  transfusion-related fatalities please see this news.

With this draft guidance document the FDA intends to provide blood establishments collecting blood and blood components with recommendations for questioning and deferring donors of blood and blood components. Read more.

The British regulatory authority MHRA has published a new questions-and-answers document concerning the new rules on the import of active ingredients laid down in the Directive 2011/62/EU on the prevention of the entry of falsified medicinal products. Read more here.

In many pharmaceutical dosage forms the release of the active substance changes in comparison with the conventional release. For the quality of these products the EMA issued a draft guideline. To find out more about the EMA requirements with regard to the quality of products with modified API release please read this news.