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 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

Contact details

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

Enquiries

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: TGA, PO Box 100
Woden
Australian Capital Territory 2606
Phone: 1800 020 653
Email: info@tga.gov.au