Execute drug batch recalls and report closure to regulators
Trace every consignee of the recalled batch from dispatch records, and reconcile quantities manufactured, distributed and returned before supervised destruction or reprocessing. Quality Assurance can follow up every shortfall and give the licensing authority a closing report with root cause and corrective actions.
Starts when
A recall decision arising from an NSQ or spurious finding, a confirmed market complaint, an adverse stability result, a regulator's direction, or an export customer's notification.
Runs: Per recall event; several times a year for a multi-product manufacturer, plus mock recalls at planned intervals.
The process is a starting point. The standards are yours.
Configure by product, authorisation and destination market. Regulatory Affairs and authorised quality personnel retain product-change, submission and batch-release decisions. Safety reporting and UCPMP requirements use the applicable reviewed scope.
Industries
Industries