Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 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
Read all Breaking News from RegLink
Tags: CGMPs, australia