In a press release the EMA announced the publication of a final report on the International API Inspection Programme. The report presents the results of a 2-year international collaboration between competent authorities from Europe, Australia, FDA and EDQM. Read more here.
In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed to by the Biologics Working Party and adopted by the CHMP/CAT. Read more here.
With date of application on 1st july, the chapter 5.2.8 of the EP about Minimising the Risk of transmission of Animal Spongiform Encephalopathy agents via human or veterinary medicinal products was revised. More details can be found here.
The European Commission's Directorate General for Health and Consumer Policy (DG SANCO) published the draft of the revised 'Guideline on Good Distribution Practice of Medicinal Products for Human Use' for public consultation. The guideline has been completely revised. Read more.
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.
In June the ECDC (European Centre for Disease Prevention and Control) published a technical report on the prevention of Creutzfeldt-Jakob (vCJD) disease transmission in medical settings in EU Member States and Norway. Read more.
The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how it will inform Medical Devices manufacturers about new or modified requirements/expectations by use of "Notices to Industry" Letters in the future. Read more.
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 WHO Expert Committee published their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.
Because of the extensive reorganisation of applications for variations contained in the Variations Regulation from 2010, a revision of the "Guideline on stability testing for applications for variations to a marketing authorisation" became necessary. Read here, which stability testing data are required by regulatory authorities in case of applications for variations.
The European Medicines Agency (EMA) has published the new Compilation of Community Procedures on Inspections and Exchange of Information. Although primarily addressed to inspectorates, it is also an interesting document for those being inspected. Read more.