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GMP Clearance code tables guidance

Manufacturing steps
6 July 2020
Download GMP Clearance code tables guidance

Description

GMP evidence is required for manufacture of a medicine or an Active Pharmaceutical Ingredient (API) used in a medicine, intended for supply in Australia. Evidence to demonstrate GMP compliance for product registration purposes for overseas sites can be done via the GMP clearance desktop pathway.

This guidance aims to assist sponsors when using the code tables for GMP Clearance applications by providing:

  • instructions on how to navigate the TGA Code Tables
  • interpretation of common manufacturing steps
  • information regarding validation rules within the various product registration or listing systems.

Please note, the guidance is not intended for:

  • clarification of dosage forms or their validation in registration/listing systems
  • clarification of manufacturing steps or dosage forms for GMP licences for Australian manufacturing sites
  • biologicals, human blood and blood components and Haematopoietic Progenitor Cells (HPCs). Australia has its own manufacturing standard for these product types. However, where the manufacturing site performs only sterilisation of these product types, this guidance may be used.

Contents

  • About this guidance
  • GMP clearance pathways
  • Manufacturing steps
  • Regulatory system validation
  • Manufacturing step groups
  • Interpretation of common manufacturing steps
  • Troubleshooting and common issues

Version history
Version Description of change Author Effective date
V1.0 Original publication Manufacturing Quality Branch July 2020

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