GMP News - Analytical Quality Control


The New Role of PAT as an Integral Part of QbD

According to Ken Leiper, member of the Steering Committee of the University of Heidelberg QbD / PAT Conference 2010, PAT and QbD are not mutually exclusive but they are complementary. Read more here.



USP seeks Submission of Proposals for Monograph Modernization

USP is seeking submission of proposals to support the modernization of USP-NF small molecule and excipient monographs that utilize outdated technology (e.g., use of packed gas chromatography columns), have safety/environmental concerns (e.g., chlorinated solvents, etc) or are missing procedures for key aspects such as impurities. Click here to read more.



New EMA Report on the 2008 Sampling and Test Programme

The examination of centrally permissible trade medicinal products, co-ordinated by the EMA, showed that more than half of the products still had open issues, triggered, amongst other things, by the analysis methods used. You can read more here.



EMA Guideline for Stability Testing for Applications for Variations in revision

The European Medicines Agency EMA announces the revise of its "Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation". The time allowed for submitting comments and change requests is running. Learn more here.



Central Anti-Counterfeit Laboratories - a Strategy to fight against Counterfeit Medicines

Pharmaceutical Manufacturers increase their efforts to fight against counterfeit medicines by establishing dedicated facilities. One example is the Central Anti-Counterfeit Laboratory which is an integral part of the sanofi-aventis group's initiative against counterfeiting. Click here to read more.



FDA Warning Letters on HPLC 2009

Last year's FDA warning letters included some observations on HPLC systems. The most important extracts from these warning letters are summarised in this news item. See here.



EMA publishes "Draft Guideline on Validation of bioanalytical Methods"

To define key elements and provide recommendations for the validation of bioanalytical methods, the EMA published a draft guideline, open to comment until end of May 2010. More details can be found here.



Genotoxicity Research - New HMPC Guideline for Herbal Medicinal Products

A new HMPC Guideline contains suggestions on how genotoxicity testing in (traditional) herbal medicinal products can be simplified, so herbal products and preparations can be more easily included in the collective list ("community list"). Read all additional information here.



FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed

The final FDA Guidance for Industry on mechanical calibration of dissolution apparatus 1 and 2 was published in January 2010. Compared to the 2007 draft version, the guideline was completely revised; however, the conclusions and the recommended method for mechanical calibration remained unchanged. Read more here.



Recall of USP 33-NF 28!

During the conversion of monographs to a new design, errors have slipped into USP 33-NF 28. Therefore, the USP Convention recalls USP 33-NF 28 as a whole, and the pharmacopoeia will not come into force on 1 May 2010, which had originally been planned. Further information can be found here.



Recent Changes Concerning the USP Dissolution Performance Verification Test

On 1 December 2009, changes of the USP regarding the Dissolution Performance Verification Test came into force. Besides the General Chapter <711> was revised. Details can be found in our news item.


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