PIC/S Guide for Good Manufacturing Practice for Medicinal Products - Australian Government

Service summary

You may require this code if you are involved in the manufacture of biologicals and therapeutic goods.

The standards and principles contained in this Code are intended to serve as a reference for practice, as requested under the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Co-operation Scheme.

It covers areas such as compliance, quality management, personnel, premises and equipment, and documentation.

Please note that there are various codes for medicines, medical devices and chemicals which are amended on a regular basis.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required by your business

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Regulations 1990 (Australian Government)

Contact details

Enquiries
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
TGA, PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800020653
info@tga.gov.au

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.