- Recognition for overseas tests sites

- Information on the revised Notification of GLP Recognition document

Recognition for Overseas Test Sites

The September 2005 edition of NATA News discussed the involvement of NATA in the recognition of facilities outside of Australia in the context of the Mutual Acceptance of Data (MAD) directives.

In that article, we advised that it is not appropriate nor relevant for NATA to inspect overseas facilities or test sites because recognition by NATA would not oblige regulators to accept data from any country not formally adhering to the MAD decision. Where the country is an adherent to MAD, GLP inspections would be conducted by the relevant national GLP compliance monitoring authority.

This was further clarified in the December 2005 edition of NATA News. NATA would only inspect permanent test facilities or sites, such as a laboratory or animal house, located in a country that does not have a GLP compliance monitoring authority at the request of the relevant Australian regulator.

On some occasions, however, NATA inspects 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 those done in field plots or paddocks being used in an animal or crop residue study. All aspects of the activity 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 inspect the overseas "site". The inspection 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. Records of the GLP activities would be reviewed during study audits.

Before such an inspection occurred, 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.

Revised Scope of Recognition/ Notification of GLP Recognition document

GLP facilities were advised in December 2006 that the policy for describing the scope of recognition of GLP facilities was revised, effective 1 November 2006.

Classes and sub-classes are no longer included in the scope of recognition and the scope for all GLP recognised facilities is as follows:

This facility complies with the OECD Principles of Good Laboratory Practice (1997)

The conduct of non-clinical health and environmental safety studies of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs, food additives, feed additives and industrial chemicals.

The change gives the responsibility for ensuring the GLP compliance of studies to the facility, as required by the OECD Principles of GLP. Any studies found to be non-compliant at a NATA assessment would need to be reissued as an amended report with a revised compliance statement. As with all non-compliant studies, regulators and members of the OECD Working Group would also be notified.

The format was further revised in January 2007 to ensure that client and other interested parties could access information regarding the types of studies inspected from the NATA website. All GLP recognised facilities will be provided with a new document detailing their scope of recognition and the types of studies inspected. This is to be known as the Notification of GLP Recognition document.

The list of the types of studies that have been inspected by NATA are in accordance with the Appendix to Annex III to C(89)87(Final)/Revised in C(95)8(Final) of Document No 2 - Guidance for GLP Monitoring Authorities Revised guides for Compliance monitoring procedures for Good Laboratory Practice.

All studies conducted by a facility must continue to be listed in the master schedule and a selection of these will be inspected by NATA at reassessments. The types of studies inspected listed on the Notification of GLP Recognition document will be revised accordingly.

When choosing studies to be assessed, emphasis will be given to studies conducted in areas not previously reviewed at an assessment or study audit. Please note that studies may also be inspected at the request of a regulator.