Pharmaceutical GMP & GLP
At MediHerb therapeutic goods are produced under strict pharmaceutical practices – which is technically challenging and requires specialised expertise as a total commitment to quality assurance.
Quality in our Manufacturing Facility – Good Manufacturing Practice
In Australia, herbal and nutritional products are regulated by the Therapeutic Goods Administration (TGA), part of the Federal Government. 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