GMP News - Analytical Quality Control


ECA SOP: Methods for the Identification of Trends in Production and QC

An SOP on the handling of Out of Trend Results is the objective of ECA Working Group on QC. Both trend analysis of statistical process control in the production as well as trend analysis in stability studies will be addressed. More information can be found here in the News.



How to identify Out-of-Trend Results in Stability Studies?

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.



FDA publishes ICH Q4B - Annex 6 on Uniformity of Dosage Units

The ICH Guideline on Uniformity of Dosage Units was published in June 2014 by the FDA and thus became effective in the USA. More information can be found here.



What is the difference between OOS / OOE / OOT?

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.



Handling of OOS Results in Europe

FDA's Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the meantime, Europe - through the British MHRA and the German ZLG - has also developed requirements on that topic. Read more here about the most important regulations of the respective guidance documents.



EMA NIR Guideline finalised

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.



EMA publishes Document on the Validation of analytical Methods

Is it possible to use the results of collaborative trials for analytical methods to prove the laboratory- and product-specific validation of a method? From the perspective of this EMA reflection paper the concrete specifications are missing. These will be developed in the future. Find out more in this news.



European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D

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.



ICH gets new Members and informs about the ICH Q3D Implementation

The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. Read more about the current decisions of the ICH Steering Committees.



Waiting for ICH Q3D (Step 4): Revision and Implementation of national Regulations delayed!

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.



HMPC Q&A Documents on Herbal Medicinal Products published

Current questions and answers about the framework for herbal medicinal products and traditional herbal medicinal products are addressed in a new EMA/HMPC document. The document also addresses herbal medicinal products which don't have a European tradition. Read more in this News.



Publication of HMPC Documents on Essential Oils

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.



Dissolution Testing - Requirements of the Chinese Pharmacopoeia

The Chinese market is becoming more and more important for many pharmaceutical companies. Therefore, it is essential to know the relevant regulatory requirements in China, especially the requirements on dissolution testing as they aren't harmonised with the other pharmacopeias (Ph.Eur., USP and JP). Read more here in the News.



Organic Impurities Testing: USP plans extensive Revision of General Chapters and Monographs

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.



Revision of the USP Chapter on Spectroscopic Methods

A new concept for the representation of different analytical and spectroscopic methods (AAS, IR, UV, etc.) has been presented as general chapter in the USP. In the future, there should be two general chapters for each method. The concrete implementation is planned in the USP38/NF33. Read more here in the News.


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