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

Description

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 is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Enquiries

Therapeutic Goods Administration

Department of Health

Mailing address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)