Quality

China Pushes Pharma to Comply With Revised GMPs

China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More

Health Canada Incorporates QbD In Updated Quality Guidance

Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s (ICH) registration for human use quality standards. Read More