All news articles for November 26, 2012

Indian plans for EU API import compliance still being discussed

26-Nov-2012

Indian Plans to hand quality oversight of APIs shipped to Europe to ‘competent authority’ are still being discussed according to Pharmexcil.

Euticals suspends production after high levels of explosive chemical found at UK site

26-Nov-2012 By Natalie Morrison

Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 By Natalie Morrison

Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

News from Onyx, Pacific Biomarker and Rx&D – People on the move

26-Nov-2012 By Natalie Morrison

Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceutical outsourcing, including news from Onyx, Pacific Biomarker and Rx&D.

EC makes Switzerland exempt from API ‘written confirmation’ requirement

26-Nov-2012 By Gareth Macdonald

APIs made in Switzerland won’t need ‘written confirmation’ of quality after the EC deemed the country's manufacturing standards meet its requirements.