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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 Review is to foster a constantly evolving Quality System to improve and develop processes to meet the company’s changing direction and needs. It promotes management ownership and responsibility for quality. Quality Systems Review (QSR) should ensure the QMS is achieving its objectives. During QSR meetings; complaints, corrective actions, customer feedback and relevant trends are a couple of applicable key focal points. A copy of the QSR meeting minutes and actions[…]

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 suppliers, use a risk based approach. When desktop audits are performed, ensure that they record any certification the organisation has and that you maintain a current certificate. There have been many instances where organizations have been caught out by regulators for not having the updated supplier certificate. Supplier re-evaluation should also be performed; this can be as simple as asking for an updated registration certificate. When a supplier has no certification, use history[…]

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 this regulation by implementing: ISO 22716 Cosmetics – Good Manufacturing Practices (GMP). For further information regarding GMP implementation contact Compliance Management Solutions or your nearest SGS agency. About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.

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 22716 Cosmetics – Good Manufacturing Practices (GMP). For further information regarding GMP implementation contact Compliance Management Solutions. About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.

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 22716 Cosmetics – Good Manufacturing Practices (GMP). For further information contact Compliance Management Solutions. About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.

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 assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification.  

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, ISO 13485 medical devices etc. The definitions are as follows: Corrective Action – action taken to eliminate the cause of an EXISTING nonconformance in order to prevent recurrence. This is pretty straight forward- an organization has a non conformance and they implement training or a change to prevent recurrence. Preventive Action – action taken to eliminate the cause of a potential nonconformance in order to prevent recurrence. If you are[…]

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 use recognised standards (such as ISO 2859) to determine your sample size. In addition, the sampling plan should be commensurate with risk. If product A is low risk then sampling should be lower than product B which is high risk. If a standard is not used, statistics can also be used to determine a sample size. You don’t want to be spending too much time and money on a low risk[…]

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 of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries. Quality Management Principles The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many[…]

The ICCR (International Cooperation on Cosmetic Regulation) agreed to implement ISO 22716 in their respective regions. Effective 11 July 2013, a new regulation will be imposed which will ensure that cosmetic products be manufactured according to GMP (Good manufacturing Practices). This means that there will be a global cosmetic network whereby cosmetic companies (includes importers/exporters etc) will be required to demonstrate compliance to this new regulation. Cosmetic manufacturers should prepare for this new requirement in order to avoid any loss of market approval.  Companies can demonstrate compliance with this regulation by implementing ISO 22716 Cosmetics – Good Manufacturing Practices (GMP). This standard introduces a management system approach with a review[…]