Common use of Audit Follow-Up Clause in Contracts

Audit Follow-Up. The customer is responsible to review the proposed actions included in the audit report by the manufacturer to ensure that the audit deficiencies have been adequately addressed in relation to the cGMP Status of the material(s) The manufacturer is responsible to provide to each customer periodic updates of progress with the corrective actions based on the timelines proposed in the audit report. The customer is responsible for follow up to check that corrective actions have been appropriately addressed in a timely manner. The customer is responsible for follow up and closure of CAPA’s resulting from the audit and will also decide if a specific follow up audit related to the deficiencies is necessary. Within 3 years after the audit took place the API Manufacturer is obliged to inform the ACI about any major changes to the scope covered by the audit report (examples are: changes in the manufacturing process/location and specifications)