Analytical Quality Control News

FDA Guideline on Dissolution Testing

The FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. Read on to get more information about FDA's Guideline on Dissolution Testing.

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Consequences of the new MHRA Guideline for Excel

In March 2015, the British authority MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). These requirements apply to all electronically stored data - regardless of the technology used for data saved in MS Excel. Learn more about the relevance of the MHRA Guideline for MS Excel.

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In-process revision to USP <1058> - Analytical Instrument Qualification (AIQ)

An in-process revision to USP <1058> on Analytical Instrument Qualification (AIQ) was issued for public comment in the May-June 2015 issue of Pharmacopoeial Forum. Find out more about the changed version of USP General Chapter <1058> - Analytical Instrument Qualification. 

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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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