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Quality through Pharmaceutical Good
In Australia, herbal and nutritional products are regulated by the Therapeutic Goods Administration (TGA), part of the Federal Government. This is the same body and standard applied to pharmaceutical manufacturing. The TGA conducts regular audits of MediHerb's manufacturing facility to ensure Pharmaceutical GMP compliance.
In practice, however, 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 Quality Control and Research and Development laboratories are legally required to comply with the Australian standards of Good Laboratory Practice (GLP) under the Therapeutic Goods Act.
GLP means adherence to strict criteria such as:
- Test method reliability: validation and control
- Instrument calibration and maintenance programs
- Reagent and standard quality control
- Authorised materials and product specifications
- Quality, integrity and authenticity of data
Over 19 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 practitioner ALWAYS receives superior quality therapeutic clinical solutions.