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Quality is one of our key values.

The Quality Mission Statement is:

That the cell culture business and our Biopharmaceutical drug development business operates in compliance with TGA and FDA standards, specifically the “International Conference on Harmonisation guidelines Q7A for the manufacture of active pharmaceutical ingredients: 2001”

In addition to the above our Biopharmaceutical drug development business demands that it operates in regulatory compliance with current US FDA 21 Code of Federal Regulations and the Australian Code of GMP 2002 for the manufacture and provision of investigational medicinal products (active pharmaceutical ingredients).

Our Quality plan has developed to focus on continuous improvement opportunities identified through internal, customer and consultant audits.

The Quality department reports to the CEO and has been organised into Quality Assurance, Compliance and Quality Control units; this organisation typically represents the structure found throughout the pharmaceutical industry.

Key positions within the Quality Assurance, Compliance and Quality Control units have been recruited from the pharmaceutical industry.

Novozymes GroPep is regularly audited by its major Pharmaceutical customers, and we welcome the opportunity for new as well as existing companies to perform audits as they require.

Novozymes GroPep is currently managed under licenses granted by:

The Office of the Gene Technology Regulator(OGTR)

The Australian Pesticides and Veterinary Medicines Authority

For further information, please contact:

AUAD-quality@novozymes.com