Analytical Quality Control News

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.

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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.

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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.

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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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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.

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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.

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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.

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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.

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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.

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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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