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 site reviewing master production records, stability, validation and other quality documents. The firm was provided with a detailed audit report on the deficiencies noted and also provided with detailed consulting and guidance on how to address those deficiencies to undertake corrective actions which will be acceptable to Canada.
The firm was so pleased with the level of advice and guidance provided by DSA; that DSA was asked to return and act as their company representative during the Health Canada audit.
DSA offers a full range of services to help ensure timely approvals for your product registration submissions and establishment licenses. Contact us today.