Analytical Quality Control News

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The USP plans the modernisation of many outdated and obsolete monographs.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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Japanese Pharmacopoeia and Japanese GMP Regulations available online

On Japan's Pharmaceuticals and Medical Devices Agency (PMDA) website, you can download documents on GMP as well as on marketing authorisations for medicinal products. An English version of the Japanese Pharmacopoeia (JP) is also available. You will find the direct links in the News.

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Failures in Handling OOS Results cited in FDA Warning Letters 2013

In reviewing FDA's Warning Letters from the calendar year 2013, it has been found that 9 Warning Letters contained observations with reagrd to GMP/FDA complaint handling of OOS results. As a matter of fact, the handling of OOS results remains one of the most critical aspects during an FDA inspection. The most important citations from the Warning Letters can be found in this News.

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