GMP News - Analytical Quality Control


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.



Dissolution Testing - Planned Revision of the USP Chapter

USP's general chapter on dissolution testing <1092> should be revised. In the future, there should be greater differentiation between the dissolution testing method and the subsequent assay of the API. More information can be found here.



EU Commission issues new EU GMP Guide Chapter 6

In early April 2014, the EU Commission has published a new Chapter 6 Quality Control. The new chapter will become effective on 1 October 2014. Read more in the GMP news to the new EU GMP chapter quality control.



Combined Risk Assessment for Analytical Instruments and Computer Systems in the Laboratory

Currently the requirements for the qualification of analytical instruments and computer-based systems from USP < 1058 > do not match those from the GAMP® Good Practice Guide for validation of computerized systems in the laboratory (2nd Edition, 2012). In this news, a publication will be presented that shows one possible way of solution.



Analytical Methods - USP's Future Expectations

How can the current requirements of the ICH guidelines Q8, Q9 und Q10 be applied to analytical procedures? Read more about the USP experts group's recommendations on the development and validation of analytical procedures and about the essential aspects of this new approach.



Balances - Correction of the Requirements in the U.S. Pharmacopoeia (USP)

When assessing the repeatability in the verification of balances false positive results could be obtained by using too large weights. Thus, the General Chapter <41> with regard to balances will be changed as of 1 July 2014. Everything else you will find in this news.



Revision of the USP General Notices for USP 37/NF 32

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.



System Suitability for USP Methods - USP's Future Expectations

The USP plans the modernisation of many outdated and obsolete monographs. In the future, those monographs should contain uniform SST-requirements. A recent article published in the Pharmacopeial Forum describes the coming expectations of USP's experts group towards the parameters and acceptance criteria for chromatographic procedures. Read more in the News.


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