What are the requirements for Audit/Inspection Reports?
The APVMA will consider audit reports from: • an APVMA-authorised GMP auditor from Australia • a Therapeutic Goods Administration (TGA) auditor from Australia • an auditor from one of the overseas authorities recognised by the APVMA (ie EU, USA, Canada, NZ). In certain circumstances, the APVMA may consider an audit report from an alternative quality assurance certifying body that is internationally recognised. However, agreement must be obtained from the APVMA’s GMP Section before the audit takes place.
