GMP News - Analytical Quality Control


The Challenges of Ensuring Laboratory Data Integrity

The integrity of laboratory data generated in analytical labs needs to be ensured for paper systems, for paper and  electronic systems (hybrid), as well as for electronic systems. The problem is that "raw data" has not been defined in the new EU GMP Chapter 4. Please find in Dr. Bob McDowall's article how the definition of "raw data" in the GLP regulations can help.  



New Limit regarding unspecified Impurities for certain Substances - EDQM Updates respective CEPs

34 monographs of Ph. Eur 7.0 to 7.2 have been revised regarding the limit for unspecified impurities. Read more about the consequences for applicants of new CEPs.



Specific WHO Requirements for Dissolution Studies to Support Biowaivers

The requirements on dissolution testing and the main focuses of an inspection are at the core of the WHO document "Points to Consider for Inspections of Biowaiver Data". You can read more about this new WHO-Dokument here. 



"Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper

The control of residual solvents and organic impurities in drugs and APIs is "globally" regulated in respective ICH guidelines (resp. for the economic areas Europe, USA and Japan). For metal impurities there is no comparable harmonised document available, though. The ICH initiated the development of a new guideline in order to close this gap. Read more here.



EMA/HMPC Reflection Paper on Extracts Purification

An EMA/HMPC Reflection Paper on the Level of Purification of Herbal Preparations to be considered as such has been published. Go here for more information. 



Quality of Herbal Medicinal Products - Current EMA/HMPC Q&A Document

A new EMA/HMPC document presents 26 different Questions and Answers on Quality of herbal medicinal products/traditional herbal medicinal products. Focus is on Testing Stability: 12 Questions and Answers are dedicated to that subject. You will find more information here.



Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms

Laboratory control problems are prominent in a bolus of FDA drug GMP warning letters recently issued to companies in Asia and Europe. Please read more about this development in a very detailed article provided by the IPQ - one of the most important Journals in the GMP and regulatory environment. Click 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.


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