We can help to write the Recall Plan and SOPs to meet Health Canada’s criteria under this subdivision.
A recall is covered under – s. 50, 62 (15) (a) (b)Natural Health Product Act and Regulations., also see ACMPR and Health Canada notification and other procedures are described in Health Canada’s Product and Food Inspection Regulations.
A product recall means the product produced is non-complaint with Canadian regulations, AND, has not been detected by the producer. This will also mean formal notification to Health Canada of the recall and the corrective actions taken.
Every producer requires a tested product recall system to track, quarantine recalled the product, and correct the problem before production can continue after a recall. The recall plan will need to be in place and tested before the final inspection takes place in the final step before Health Canada issues a Producer’s License.
The Good Production Practices referred to in the Quality Assurance Report (and the Regulations and guidelines) support and integrate the recall standard operating procedures in the recall plan. For example, records of raw material and product traceability which identify by lot number the product from seed to sale.