Manufacturing & GMP

AUSTRALIA

Medicines

Australian manufacturers of medicines must hold a manufacturing licence issued by the TGA unless an exemption applies under the Regulations. To obtain a licence to manufacture medicines, a manufacturer must demonstrate, during a factory audit, compliance with manufacturing principles, which include the Australian Codes of Good Manufacturing Practice (GMP).

Overseas manufacturers must demonstrate that they meet similar standards before imported goods may be registered. Guidance on the GMP clearance of overseas medicine manufacturers sets out the evidence that is acceptable to the TGA 

Many applications for registration or listing of medicines on the Australian Register of Therapeutic Goods (ARTG) are either delayed or rejected due to a lack of acceptable evidence of the standard of manufacture of medicines. Sponsors are requested to obtain GMP clearance of overseas manufacturers prior to submitting an application for registration, listing or variation of a product.

GMP Certification may be accepted for manufacturers in countries with which Australia has a mutual Recognition Agreement. Only the orignal EU, & EFTA countries, Switzerland and Canada, have these agreements with Australia. Manufacturers from newer EU countries, New Zealand and USA must provide extensive documentation and undergo a "desk audit". If acceptable GMP evidence cannot be obtained, and for all other countries, an inspection by Australian auditors will be required.

All documentation required for Manufacturing & GMP can be found on the TGA website, please see links below.

Medical Devices

Australian manufacturers of all classes of medical devices, except Class 1, are required to undergo conformity assessment of their manufacturing quality system by the TGA before the goods are eligible for incusion on the ARTG. Overseas manufacturers must either hold CE Certification of their Quality System from an acceptable European Notified Body or undergo conformity assessment by the TGA,

ADVANTAGE MPC can assist you with all documentation, applications etc required before TGA audit/conformity assessment.

NEW ZEALAND

ADVANTAGE MPC can provide a similar service for New Zealand clients.

Getting Started...

Advantage MPC can arrange undertake the following services for you:

  • Assess overseas Certifications and documentation
  • Arrange for TGA Audits
  • Carry out pre-assessment audits
  • Assist with the Preparation of Site Master Files and Validation Master Plans
  • Arrange applications for Pre-Clearances of Overseas manufacturers (Medicines) or Manufacturer Certification (Medical devices.)

To get started, you need to refer to the websites listed below and complete the Free Online Consultation Form.

Useful Links:

http://www.tga.gov.au/manuf/index.htm

http://www.tga.gov.au/manuf/gmpsom.htm

We are also happy to recommend colleagues David Buckley and Associates Pty Ltd and  Pharmchem Technical Services Pty Ltd  (Dr Phil Marshall) for specialist GMP and quality system advice and training for pharmaceuticals, vaccines, biologicals, medical gases, blood and blood products and medical devices industries.