The Therapeutic Goods Administration (TGA) has unveiled new Good Manufacturing Practice (GMP) requirements for medicinal cannabis products that will shake up the industry starting July 1, 2023.
New GMP Requirements under TGO 93:
The updated TGO 93 requirements focus on ensuring the highest quality standards for medicinal cannabis products, including:
- GMP: Each step of manufacturing medicinal cannabis products outside Australia must meet one of the GMP standards outlined in section 13(2) of TGO 93.
- Labelling and packaging: Changes to labelling and packaging requirements for medicinal cannabis products.
- Testing: Ensuring proper testing methods are used to maintain the quality and safety of products.
- Microbiological attributes: Setting standards for microbiological quality requirements.
For imported products, the updated requirements clarify the evidence needed for GMP compliance. Australian sponsors must obtain and hold acceptable written evidence, and the TGA will recognise certification by specified foreign regulators. Keep in mind that a TGA inspection can be requested, but a certificate is not a clearance.
Why is this important?
These new requirements aim to harmonise regulations, making it easier for both Aussie and international manufacturers to maintain consistent quality standards for medicinal cannabis products. Here’s why this matters:
- Ensuring safety: The updated GMP requirements will help guarantee that all medicinal cannabis products meet safety and quality standards, offering peace of mind for consumers and healthcare providers alike.
- Fostering trust: As the medicinal cannabis industry continues to grow, these stringent requirements will build trust and confidence in the products being supplied.
- Streamlining compliance: By aligning international GMP standards, the TGA is making it easier for manufacturers to comply with regulations, ultimately benefiting the entire industry.
Preparing for GMP Inspections:
Manufacturers and suppliers of medicinal cannabis products must be ready for TGA inspections. To ensure compliance with the new GMP requirements, organisations should:
- Conduct self-assessments to identify areas of improvement.
- Familiarise themselves with TGO 93 guidance and FAQs available on the TGA website.
- Ensure that all starting materials are manufactured under GMP and hold GMP evidence.
- Prepare for various aspects of GMP inspections, including personnel qualifications, quality systems, documentation, production processes, and quality control testing.
Key Takeaways:
The updated TGO 93 GMP requirements for medicinal cannabis products in Australia signal a significant step forward in the industry’s commitment to safety, quality, and trust. As the sector continues to evolve, staying informed about regulatory changes is essential for both consumers and industry professionals. Remember:
- The new GMP requirements under TGO 93 apply to all medicinal cannabis products released for supply on or after July 1, 2023.
- Compliance with these updated requirements will help ensure the safety and quality of medicinal cannabis products for consumers and healthcare providers.
- Manufacturers and suppliers must be prepared for TGA inspections, conducting self-assessments, and ensuring all processes align with the new GMP standards.
For further information visit the TGA website or email medicinalcannabisreforms@health.gov.au