Medical Device Sponsors Before someone can supply a medical device for sale in Australia they are required to make an application to include the device in the ARTG. The sponsor is the person or company responsible for the importation of…
To ensure continuing suitability, effectiveness and adequacy of a Quality Management System (QMS) management reviews should be performed at planned intervals to include assessing opportunities for improvement and the need for changes to the QMS. The intention of Quality System…
Vendor/Supplier Evaluation The method of evaluating suppliers can be either done via physical/site audit or desktop audit. The type and extent of control applied to the supplier shall be dependant upon the effect of the product on product realization (final product). Rather than evaluating all…
Cosmetics GMP – ISO 22716 To all Australian cosmetic exporters – the new Cosmetic Regulation “Cosmetics GMP” is now in effect. This means that companies will now be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with…
A reminder to all Australian cosmetic exporters that the new Cosmetic Regulation kicks in 11 July, 2013. This means that companies will be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with this regulation by implementing:…
A reminder to all Australian cosmetic exporters that the new Cosmetic Regulation kicks in 11 July, 2013. This means that companies will be required to demonstrate compliance to this new regulation. Companies can demonstrate compliance with this regulation by implementing: ISO…
The TGA has recently published its new financial year fees. Please refer to the web address below for a summary of 2013-2014 fees. Contact CMS to avoid unnecessary fees. http://www.tga.gov.au/about/fees-130701.htm About CMS: Compliance Management Solutions is a Melbourne based consultancy…
Corrective and Preventive action: A continuous improvement tool that can be extremely effective if used correctly. This tool is used not only for ISO 9001 organisations but also for organizations that comply to Cosmetics GMP ISO 22716, TGA GMP Pharmaceuticals,…
This standard provides guidance regarding Good Manufacturing Practices for cosmetics products and has been prepared for consideration by the cosmetic industry. Todays Tip: Sampling – when preparing sampling plans for raw materials/packaging/bulk or finished product, don’t randomly allocate qty but…
ISO 9001:2008 ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to. It can be used by any organization, large or small, regardless of its field…