Since 1991 Australian herbal products have been regulated by the Therapeutic Goods Administration (similar to FDA), part of the Federal Government. This is the same body and standard applied to pharmaceutical manufacturing. There is a vast difference between pharmaceutical GMP and Current Good Manufacturing Practice (CGMP) which covers all foods and dietary supplements in the US. An equivalent to the Australian pharmaceutical GMP would be the FDA drug CGMP. The TGA conducts regular audits of MediHerb's manufacturing facility to ensure pharmaceutical GMP compliance.
The standards of pharmaceutical GMP will soon be required in the UK and other parts of Europe. MediHerb has had over 18 years of manufacturing to these standards gained valuable knowledge and experience. We have learned that in practice, herbal manufacturing under pharmaceutical GMP is more complex than for conventional drugs because of the extra complexity conferred by the varying constituents present in the herb's biological matrix.
The pharmaceutical code of 'Good Manufacturing Practice' (GMP) is a quality assurance program that ensures:
- Validated equipment and processes
- Documented processes and systems
- Detailed records of each stage of manufacturing of each and every batch of product
- Control of the manufacturing environment, air and water
- Control of manufacturing materials, via quarantine, segregation and reconciliation
- Stability testing of goods offered for sale
- Documentation of customer complaints
Quality in the Laboratory - Good Laboratory Practice
The MediHerb laboratories are legally required to comply with the Australian standards of Good Laboratory Practice (GLP) under the Therapeutic Goods Act, the same Federal body that governs the pharmaceutical industry.
GLP means adherence to strict criteria such as:
- Test method reliability: validation and control
- Instrument calibration and maintenance programs
- Reagent and standard quality control
- Authorized materials and product specifications
- Quality, integrity and authenticity of data
Over 20 years of compliance with pharmaceutical GMP and Therapeutic Goods Administration requirements further underscores our own dedication to making the most superior quality products.
At MediHerb our world-leading understanding of all these quality issues ensures that the health care professional ALWAYS receives superior quality efficacious herbal solutions.
That's the guarantee of the MediHerb Philosophy