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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 user guide 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 user guide 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 user guide
- GMP clearance pathways
- Manufacturing steps
- Regulatory system validation
- Manufacturing step groups
- Interpretation of common manufacturing steps
- Troubleshooting and common issues
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | Manufacturing Quality Branch | July 2020 |