Australia Proposes Guidance on Role of Authorized Person in Drug Manufacturing Process

Posted 04 June 2013 | By Ansis Helmanis 

Australia's Therapeutic Goods Administration has opened a new consultation on proposed guidance regarding the individual (known as the Qualified or Authorised Person) that must certify that a drug has been manufactured according to the requirements of the marketing authorization and cGMPs. 

The Australian system is different from the European system of batch release by a Qualified Person, which is why the current PIC/S Guide to Good Manufacturing Practice for Medicinal Products has not been adopted in Australia.

The proposed guidance is specific to Australia's requirements on the release of medicinal products. The proposal also covers investigational medicinal products, and medicines from biological origin, such as vaccines and biotechnology drugs. However, it does not apply to some biologic products, such as those containing or derived from human cells or human plasma. 

The deadline for comments is 6 September 2013.


TGA Guidance on Authorised Persons

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Tags: CGMPs, australia

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