Understanding TGA Good Manufacturing Practice (GMP) requirements for Australian Regulatory Submissions
Good Manufacturing Practice (GMP) is vital in ensuring the quality, safety, and efficacy of the therapeutic goods for human use (including sunscreens). In Australia, the Therapeutic Goods Administration (TGA) oversees the implementation and enforcement of GMP standards to uphold the integrity of the pharmaceutical and biotech industries.
GMP Standard Applicable in Australia:
From 3 June 2024, manufacturers of medicines (other than biologicals) supplied in Australia must meet the PIC/S Guide to Good Manufacturing Practice (GMP) – 01 February 2022, PE009-16. For the first time, the TGA has adopted the Annex 16 (Authorised Person and Batch release), and provided detailed guidance with their interpretation1.
Biologicals, as defined in Section 32A of the Therapeutic Goods Act, have different requirements. They must comply with the Australian code of GMP for human blood and blood components, human tissues and human cellular therapy products2.
How to demonstrate TGA GMP compliance:
For overseas manufacturers, a GMP certificate may not be sufficient to demonstrate GMP compliance to the TGA.
Before a product application, Sponsors must demonstrate GMP compliance of all manufacturers involved in manufacture of Active Pharmaceutical Ingredients (APIs) and manufacture, testing or packaging of the medicine3 . Evidence must also be maintained the whole time the product is registered in Australia.
GMP evidence is specific to the type of therapeutic goods and the manufacturing steps, and can be:
- GMP licences issued to Australian manufacturers for sites in Australia that manufacture therapeutic goods (excluding medical devices), where either the manufacturer or the goods are not exempt.
- GMP clearances issued to Australian Sponsors for overseas manufacturing sites.
Of note, the GMP clearance pathway may not be applicable to biologicals and some complementary and listed medicines, including sunscreens.
TGA GMP Clearance:
GMP Clearance is a non-statutory mechanism used to verify that overseas manufacturing sites comply with the principles of GMP for products supplied in Australia.
GMP Clearance can be obtained via three major pathways:
- Mutual Recognition Agreement desktop assessment (MRA Pathway)
- Compliance Verification desktop assessment (CV Pathway)
- TGA on-site inspection
The pathway, document requirements and processing timelines are determined by the location of the manufacturing site, its inspection history and the available GMP evidence.
GMP clearances must be maintained by the Sponsor while the product is supplied. Therefore, maintenance of clearances (monitoring expiry dates, understanding the process and managing renewals and extensions) is a critical product registration maintenance activity. Breakdowns in this process can impact continuity of supply.
The Adjutor Advantage:
The Adjutor Group has extensive experience applying regulatory GMP processes for our clients.
To ensure clients comply with their GMP obligations, Adjutor prioritises proactive communication and comprehensive support. We begin by understanding the situation and offer tailored guidance on procedural intricacies and documentation requirements. Our expert team remains accessible throughout the process and navigates sponsors through the GMP process with confidence and efficiency, ultimately facilitating success in bringing safe and compliant products to market.
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References:
1GMP requirements for medicinal products: PIC/S Guide to GMP PE009-16 (tga.gov.au)
2Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products | Therapeutic Goods Administration (TGA)
3Evidence of GMP for prescription medicines | Therapeutic Goods Administration (TGA)
