Recognition of GLP complaince for overseas test facilities and test sites

Recognition of GLP complaince for overseas Test Facilities

NATA has a number of overseas member facilities accredited to ISO/IEC 17025 and other ISO/IEC standards and guides. This is because either there is no domestic accreditation body or the domestic accreditation body is not in a Mutual Recognition Agreement or does not currently offer accreditation in the required field of testing or inspection.

Facilities located in countries without a national GLP compliance monitoring program may also
wish to be recognised as GLP compliant. However, NATA is only obliged, under the Mutual Acceptance of Data (MAD) directives, to inspect Australian facilities. These directives are an integral part of the OECD Principles of GLP. They state that data must be accepted internationally for purposes of assessment by OECD member countries and non-member countries (which are adherents to the MAD decision) if it is generated in a facility that is recognised as GLP compliant by the national GLP compliance monitoring authority.

NATA can only inspect facilities or sites located overseas if:
  • a request is received from the relevant Australian regulator, and;
  • the facility or site was located in a country that does not have a GLP compliance monitoring authority adhering to the Mutual Acceptance of Data (MAD) directives.
Requests for GLP recognition for test facilities located in countries that are adherents to the Mutual Acceptance of Data (MAD) directives should therefore be directed to the relevant national GLP compliance monitoring authority. A list of these can be found on the GLP section of the OECD website.

Recognition of GLP complaince for overseas Test Sites

On some occasions NATA may inspect an Australian-based facility that periodically undertakes a component of its GLP study activity outside of Australia. This would be where the GLP activities are carried out at a temporary 'site' such as field plots or paddocks being used in an animal or crop residue study. The activities undertaken must be controlled by the Australian-based test facility or test site responsible for the study or phase of the study.

Depending upon the activity being undertaken, NATA may opt to perform an on-site inspection of the overseas 'site'. This would include observing processes such as dosing or spraying, sampling etc and assessing the suitability of equipment and storage conditions for samples and test items. In addition, records of the GLP activities would be reviewed during study audits. Before such an inspection occurred, however, the national GLP compliance monitoring authority of the country in which the activity is be being undertaken would be consulted. The 'site' inspected would not be included in NATA's list of GLP compliant facilities and could not itself claim that it was GLP compliant in its own right.

There would be no obligation on the part of regulators to accept the outcome of an inspection by NATA. The facility or site inspected would be listed in NATA's annual report to the OECD GLP Working Group, however, it would not be included in the Australian GLP compliance monitoring program and it would not be able to claim recognition under the Australian program.