GMP News - Analytical Quality Control

Different methods for the identification of OOT results in ongoing stability studies have been described in a PharmTech article. The conclusion is that there is an enormous need for a regulation with regard to this topic. More information can be found in the News.

In the meantime - beside OOS results - the terms OOE and OOT have become more and more frequent. But what do those abbreviations mean? How to implement the handling of OOS, OOE and OOT results in practice? More information can be found here.

The EMA has published the final guideline on the use of Near Infrared Spectroscopy (NIRS). NIRS is one of the most important technologies in PAT applications. The guideline covers qualitative and quantitative NIRS applications. Particularly worth mentioning is the fact that an addendum on the guideline's scope was published just in June 2014. You will find further information in this news.

The publication of the final ICH Q3D guideline, which has been announced for September of this year, will lead to extensive revisions to chapters and monographs in the European Pharmacopoeia. Find out in what steps the Pharmacopoeia Commission will proceed.

Since the end of the comment period for the "Draft Consensus Guideline" published in 2013, the ICH Q3D guideline has been in process for half a year. One may wonder whether the final document will be published this month as initially planned. This has consequences on other important national regulations. Read more here.

Essential oils used as API in herbal products lead to - from a regulatory view - a wide range of questions. At the moment, there is no EMA/HMPC Guideline. Now, the final "Reflection Paper" has been published. Moreover, current questions and answers about essential oils have been added to a Q&A document. Read more in the News.

In the framework of a modernisation initiative including a new and a revised general chapter, the USP has set new standards for the control of impurities in APIs and medicinal products. Read more here.