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.