Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA. vii Responsible Entity: Sponsor / Supplier / Importer responsible for the recall actions. viii Reason / Issue: Reason for the recall action. ix Recall Action: Recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues o ...

The manufacturer shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical device. Validation of processes for production and service provision: 7.5.2.1 General 7.5.2 The manufacturer shall validate any processes for production and service provision where t ...