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. About CMS: Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA/European (medicinal products/medical devices) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.

What is a medical device? As per the Therapeutic Goods Regulation 2002, Section 41DB, a medical device is: 1.    ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and that does[…]

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. 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 and registration.

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 medical devices into Australia, and/or the supply of medical devices in Australia, and/or the export of medical devices from Australia, as well as making application to the TGA to have their device included in the ARTG. The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia. If you are an[…]

What is a medical device? As per the Therapeutic Goods Regulation, Section 41DB, a medical device is: ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and that does not achieve[…]

Internal audits MUST be completed for all organizations that are ISO 9001/13485/22716 certified. It is a process that an auditor will review whether at surveillance or re-certification. If you don’t perform internal audits in your organization the probability of striking a MAJOR NC against you is extremely high. The objective of the audit program is to ensure continuing compliance to the requirements of ISO 13485, ISO 9001 and ISO 22716. A first party audit (aka internal audit) schedule should always be used. Audits will only be conducted by appropriately trained and competent personnel: trained by a recognized body or successful completion of at least three audits as a trainee auditor completion[…]

Deviations may arise as a result of but not limited to: material/product – contaminated, out of specification machine/equipment –  failed calibration,  validated operating parameters violated method/procedure – approved process not followed personnel error – not appropriately trained or failing to comply with training requirements, environment – environmental monitoring (temperature/humidity/pressure), water, bioburden etc There are a number of steps to be performed when Nonconforming product is detected: 1)    Contain the Product  Affected material must be appropriately labelled and where applicable, controlled electronically immediately to prevent misuse. 2)    Investigate and Determine Root Cause  The investigation should identify the root cause. Any other potential lots affected should also be identified and contained if[…]

What is a medical device? As per the Therapeutic Goods Regulation, Section 41DB, a medical device is: ‘any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and that does not achieve[…]

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 organizations 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 having[…]

Historically, all equipment/measuring devices that are calibrateable in organizations are calibrated. Rather than calibrating every measuring device, adopt a risk based approach. Use this method also to indicate where equipment qualification is required (ie IQ/OQ/PQ). Eg, equipment that is classified as risk levels with severities 3 (serious),4 (critical),5 (catastrophic) will require qualification and calibration. Equipment that are low risk – severities 1(negligible) and 2(minor) will not require any qualification/calibration.   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[…]