This section is for manufacturers of blood and blood component products. You should also see 'Manufacturing basics' which includes information for manufacturers of all types of therapeutic goods.

Codes of practice

• Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products
  Applies to blood, human tissues and human cellular therapy products manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance

Guidelines and standards

• Current standards applicable to TGA-licensed HPC manufacturers
  Clarification about product standards that apply to haematopoietic progenitor cells
• Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
  Describes the scope, detail and depth of information required for Technical Master Files to demonstrate the safety and quality of blood, blood components and haematopoietic progenitor cells
• Guidance on licensing/certification inspections
  The TGA performs inspections of Australian manufacturers of therapeutic goods