Quality Management

Documentation

Documentation

Every batch and/or shipment of material, whether for domestic use or export, is supported by a range of documents covering its processing history, traceability, certificates of analysis and export documentation as required.

Certificate of Origin

This document contains details of the origin of the raw serum used in the manufacture of the Sterile Serum Batch and is available on request.

Certificates of Analysis (CoA)

Every batch of serum is sampled during manufacture and is tested. The results of these tests are recorded on the Certificate of Analysis alongside the specified values for each test item.

Animal Health Certificates

Animal Health Certificates issued by the National Veterinary Authorities (MAF New Zealand and DAWR Australia - previously DAFF) attesting to the origin and health of the animals which the product was derived from are included with all export shipments from Australia or New Zealand. These Animal Health Certificates are prepared according to a format and content that is agreed to by the issuing authority and the competent authorities of the country of destination.