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Faecal microbiota transplant (FMT) products: Interpretative and technical guidance on GMP requirements

14 September 2020
Download Faecal microbiota transplant (FMT) products: Interpretative and technical guidance on GMP requirements

Description

This guidance is for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products and provides information on:

  • Therapeutic Goods Administration (TGA) manufacturing license requirements
  • TGA interpretation and expectations for compliance with specific sections of the Australian Code of Good Manufacturing Practice (GMP) for human blood and blood components, human tissues and human cellular therapy products

We welcome your feedback on this guidance. Please email your feedback to the Manufacturing Quality Branch.

Contents

  • About this guidance
  • Why FMT products are therapeutic goods
  • Roles and responsibilities
  • Regulation of FMT products
  • Conforming with Therapeutic Goods Orders (TGOs)
  • Manufacturing requirements
  • GMP principles
  • Australian code of GMP
Version history
Version Description of change Author Effective date
V1.0 Original publication Manufacturing Quality Branch September 2020

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