DSA was recently by hired by one of our manufacturing clients in in Asia to determine if their manufacturing documents would meet Health Canada expectations.
Health Canada requires that all GMP records are made available in English or French. The first part of the project for the client, was to undertake translation of all their GMP records. Once the translation was completed; records were sent to DSA for review.
One of our Senior Quality Consultants was tasked with the documentation review. The client was provided with detailed feedback including a gap assessment and areas that need improvement before
their master production document can be rated as “compliant” for Canada.