"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.
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.