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Office of Manufacturing Quality

The Office of Manufacturing Quality (OMQ) operates within a defined quality management system, striving towards continuous improvement in efficiency, consistency, quality and timeliness in the delivery of regulatory services to industry.

The OMQ's business goals are:

  • Raising levels of compliance with the Australian Manufacturing principles
  • Improving the efficiency and effectiveness of processes for the review of manufacturing quality
  • Maintaining open and effective stakeholder engagement
  • Upholding high standards of organisational governance, leadership and management

The OMQ's role includes:

  • To influence and promote regulatory compliance of Australian manufacturers; and the licensing of these manufacturers
  • The provision of assessment services to product regulators concerning the extent of Australian Good Manufacturing Principles (GMP)/ Quality Management Systems (QMS) compliance of overseas manufactures, and
  • GMP auditing and clearance of overseas manufacturers supplying therapeutic goods through their Australian Sponsors

The OMQ service to industry includes:

  • Provision of audit teams for domestic and overseas audits of manufacturers
  • Special audits to investigate manufacturing deficiencies including non-compliance with GMP and the recall of therapeutic goods
  • Development of guidelines to interpret GMP for changes in technology and regulatory directives

OMQ International involvement includes:

  • Development of, and participation in, cooperative and mutual recognition agreements with competent overseas authorities, confident of their expertise in determining GMP, suitable with Australian standards
  • Participation in the development of international standards, and training of overseas GMP auditors

Enquiries about manufacturing therapeutic products

  • Email:
  • Fax: 02 6232 8426
  • Phone:
    • 1800 446 443 (freecall within Australia)
    • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
      • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
      • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
  • Web: Information for manufacturers

Addresses

  • Postal address: Office of Manufacturing Quality, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia
  • Street address (for courier deliveries): Office of Manufacturing Quality, Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia

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