Office of Manufacturing Quality
Staffing
On site audits of manufacturers are carried out by GMP/QMS auditors of the Office of Manufacturing Quality (OMQ). The GMP/QMS auditors have extensive practical experience in the manufacture and quality assurance of therapeutic goods. In addition, TGAL staff and the relevant TGA product regulators may be called upon to provide technical assistance during the audits.
Administrative staff manage the processing of applications for licences and GMP/QMS certificates.
The Overseas Clearance Unit consisting of administrative staff and GMP auditors has been established within OMQ to manage GMP clearance applications and assess documentary GMP evidence for overseas manufacturers (desktop audits).
Role of the Office of Manufacturing Quality
The role of the OMQ incudes:
- GMP/QMS auditing for Licensing or Conformity Assessment of Australian manufacturers of therapeutic goods;
- GMP/QMS auditing and approval of overseas manufacturers supplying therapeutic goods to Australia;
- conducting (where necessary) desktop audits of overseas manufacturers;
- special audits to investigate problem reports and recalls of therapeutic goods;
- revision of the Codes of GMP to reflect changes in technology and overseas requirements;
- verification of GMP compliance for certification for therapeutic goods to be exported.
International involvement of OMQ includes development of, and participation in, inspection/auditing agreements with overseas authorities, participation in the development of international standards, and training of overseas GMP/QMS auditors.