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Australian code of GMP for human blood and tissues

24 August 2000

To meet the requirements of the Therapeutic Goods Act 1989, blood and tissue banks must meet the requirements of the Manufacturing Principles, which reference the Australian Code of Good Manufacturing Practice - Human Blood and Tissues.

How to access a pdf document

Australian code of good manufacturing practice - human blood and tissues (pdf,206kb)

Contents

  • Preface
  • Introduction
  • Key interpretations from the Act
  • References
  • Glossary
  1. Quality system
  2. Personnel and training
  3. Buildings and facilities
  4. Equipment
  5. Documentation
  6. Records
  7. Control of materiel
  8. Donor selection, donation and testing
  9. Process control
  10. Storage, packaging and transport

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Content last updated: Thursday, 24 August 2000

Content last reviewed: Wednesday, 30 August 2000

Web page last updated: Friday, 29 April 2011

URL: http://www.tga.gov.au/industry/manuf-cgmp-human-blood-tissues.htm

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