WHO in charge of Qualifying QC Laboratories for the UN
Private and governmental quality control laboratories may undergo a standardised quality assessment by the WHO to prove their compliance with the WHO requirements and therefore to be in a position to take over contracts for the UN. Read more here.
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.
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.
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.