GMP News - Analytical Quality Control

The generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results is the first project of a new ECA Analytical QC Working Group. In a first step the OOS Flow Chart had to be established, the second step comprised the development of an OOS SOP. Please read here for more details.

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 list of monographs in need of revision was updated on 26 April 2011. Read here which monographs the USP plans to modernise.

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.

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.

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.