Keeping GMP compliance in a changing world of regulation is tough. ASU has a range of courses in our Pharmaceutical Department that prepares you for the quality requirements of international agencies like the US-FDA.
GSK Canada in trouble:
(Reuters) - A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.
GSK said it is working to rectify the problems and does not expect a delay in distributing the vaccine for the 2014-2015 flu season. The company typically starts shipping the product at the end of July.
In a warning letter dated June 12 to GSK's flu vaccine manufacturing facility in Ste-Foy, Quebec, the FDA said the company failed to take appropriate steps to prevent microbiological contamination of products, among other violations.