Reminder to Generic Drug Manufacturers

Market authorization holders (MAH) of generic drug products regulated under Division 8 of the Food and Drug Regulations are required to file submissions to update their labelling to ensure consistency with that of the Canadian Reference Products (CRP) labeling. On a...

DSA Travels to Mexico

Recently, one of our Senior Quality Consultants was tasked with an audit of a contract manufacturing site in Mexico. The purpose of the audit was to help prepare the firm for an eventual audit by Health Canada. Our Senior Quality Consultant spent 5 days at the audit...