GMP News - Analytical Quality Control


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The USP plans the modernisation of many outdated and obsolete monographs.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.



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.



Laboratory Data Integrity in FDA Warning Letters 2013

Demonstrating the integrity and security of laboratory data, records, results and information is paramount for a successful inspection for any GMP regulated quality control laboratory. To find selected key citations regarding Laboratory Data Integrity in FDA Warning Letters from 2013 indicating FDA's continued focus on data integrity as part of its international inspection program please read this news.



FDA publishes new Guidance on Validation of Analytical Methods

The FDA has published a new Guidance on the validation of analytical methods which shall replace the 14 years old existing Guideline on the topic. More details about the contents of this highly topical document can be found here.



Data Integrity - MHRA's Current Expectations

The verification of data integrity has been required by the FDA for a long time now - for example through the performance of FDA pre-approval inspections. UK's MHRA has now communicated that it expects from pharmaceutical manufacturers as of 2014 to review data integrity in the context of self-inspections. More information can be found here.



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.



Perspectives on the PQRI Extractables and Leachables "Safety Thresholds and Best Practices" Recommendations for Inhalation Drug Products

The PDA Journal revisited the topic Leachables and Extractables Testing in the September/October issue with three articles. Read more here.



USP proposes Chapter on Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems

With the proposal of <1664> Assessment of Drug Product Leachables associated with Pharmaceutical Packaging/Delivery Systems, the USP continued their activities regarding the suitability of packaging materials. Read more.



Bioanalytical Method Validation: What does the FDA expect?

What data on the validation of bioanalytical methods does the FDA expect in an authorisation dossier? Information on this question is provided by a new draft guidance for industry. Read more on the content of this document.



Revision of USP Chapter on IR Spectroscopy

The revision of Chapter <854> on IR Spectroscopy proposed by the USP contains new provisions on the acceptance criteria for the validation of this method. Moreover, a new Chapter <1854> will provide theory and practice of Mid Infrared Spectroscopy. Read more in the News.



Container Performance Testing - New Proposal for USP General Chapter <671>

Pharmacopoeial Forum 39 (2) contains a proposal for the revision of USP General Chapter <671>. Packaging systems have to demonstrate satisfactory container-closure integrity throughout the product's shelf life. It is proposed that this USP chapter will be revised to include a new permeation method for determining barrier protection for packaging systems. You will find more information in this news.



Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

The APIC has published a guideline for the management and the qualification of contract laboratories. The guideline is supplemented by detailed checklists and questionnaires, which are very useful for practice. For more information read this news.


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