Quality Assurance

Quality assurance covers all aspects that influence the quality of a product. It involves developing standards and guidelines to ensure that all products released are of the highest quality. Key Pharmaceuticals is passionate about delivering high quality products and as such we have a strong focus on quality assurance.


TGA Licence

Key Pharmaceuticals is licensed by TGA (Therapeutic Goods Administration) for the manufacture of non-sterile therapeutic goods for human use.

The licence authorises:
(a) Storage;
(b) The conduct of quality control aspects of the manufacture of therapeutic goods;
(c) Release for supply associated with the manufacture of therapeutic goods; and
(d) Secondary packaging and labelling.


ISO accreditation

Key Pharmaceuticals has been registered by SAI Global as a Quality Endorsed Company, and complies with the requirements of AS/NZS ISO 9001: 2000. The registration covers the Quality Management System for the development, procurement, packaging, release for sale, marketing and sales of non-prescription pharmaceutical products, medical devices and cosmetics.

The quality system at Key Pharmaceuticals has also been assessed by the TGA and found to comply with the requirements of ISO 13485:2003 (excluding clause 7.3 Design and Development) for Barrier Cream.


Australian Packaging Covenant 

The Australian Packaging Covenant is an agreement between companies in the supply chain and all levels of government to reduce the environmental impacts of consumer packaging. Key Pharmaceuticals became a signatory to the National Packaging Covenant (previous body) in September 2001 and has continued to support the aims of the Australian Packaging Covenant since then.

View the certificate

Download 2016 annual report


Certificate of registration

Download our current action plan

For further information please visit the Australian Packaging Covenant web site.


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