ISO 9001 / ISO 13485 clause 8.5.2 / 8.5.3 | ISO 22716 Cosmetics GMP clauses 13/14/16 | TGA GMP – Corrective and Preventive Action (CAPA)
gloizou
- Jun, 03, 2014
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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 […]
TGA (Australian) Medical Device Sponsorship
- Jun, 03, 2014
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Australian Medical Device Sponsorship 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 […]
Cosmetics GMP – ISO 22716 Eureopean Regulation EC 1223/2009
- Jun, 03, 2014
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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 […]
TGA/Australian Medical Device Sponsors
- Mar, 02, 2014
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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 […]
Cosmetics GMP – ISO 22716
- Mar, 02, 2014
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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 […]
TGA (Australian) Medical Device Sponsor
- Jan, 29, 2014
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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 […]
TGA Australian Medical Device Sponsors
- Jan, 01, 2014
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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 […]
ISO 9001 / ISO 13485 clause 8.2.2 | ISO 22716 Cosmetics GMP clause 16 – Internal Audit
- Nov, 07, 2013
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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 […]
ISO 9001 / ISO 13485 clause 8.3 | ISO 22716 Cosmetics GMP clause 13 – Control of Nonconforming Product / Deviations
- Nov, 04, 2013
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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 […]
TGA / Australian Medical Device Sponsors
- Nov, 01, 2013
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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 […]
