All Canadian Blood Services production sites are required to hold an Authorization and a Blood Establishment Licence, and sites that perform transformation activities (i.e., irradiation, washing or pooling) are required to have a Blood Establishment Registration. Drug Establishment Licences are also required for our sites that perform wholesale activities in support of plasma protein products. All of these licences and registrations are issued by Health Canada.
Health Canada must be notified in advance of significant changes to information contained in the Authorization, such as changes to labels. This requirement also applies to the Canadian Blood Services Circular of Information, which is considered an extension of our labels.
Health Canada conducts regular inspections of Canadian Blood Services facilities and operations to verify compliance with the Food and Drugs Act, and applicable regulations thereunder.
Canadian Blood Services receives a report within 20 days of the conclusion of the inspection. A written response must be provided by Canadian Blood Services to Health Canada that details the corrective action to be taken to address each observation, and its implementation date. All written responses are documented in the Audits section of our website. An overall inspection rating of compliant or non-complaint is provided by Health Canada at the end of the audit. Contact your local hospital liaison specialist for a copy of our most recent Health Canada establishment license.
Canadian Blood Services provides patient testing services in some provinces, and is required to comply with local provincial licensing regulations. Contact your local hospital liaison specialist for a copy of our most recent provincial accreditation certificate.
As a biologics manufacturer, quality audits are conducted by Canadian Blood Services as an integral part of continuous quality improvement. We conduct quality audits to evaluate internal compliance, safety, security and performance of our blood component manufacturing activities. Results of the quality audits are carefully reviewed by the department business owner, and a process improvement implementation plan is formulated.
In addition, external audits are conducted of our suppliers of materials and services. Before any product or service can be acquired, user requirement specifications are determined to ensure the material or service will meet our needs. Products or services will only be acquired from approved suppliers, determined by initial and on-going audits.