In every area of expertise listed in the OECD Guidance Document No. 2 – “Guidance for GLP monitoring authorities – Revised Guides for compliance monitoring procedures for GLP” Appendix to Annex III, No. 4 – there may be many kinds of studies that can be performed. For example, the area of expertise No. 2 – “Toxicity Studies” – includes studies conducted using the OECD Test Guidelines No. 401- 453, listed in Section 4 “Health Effects”.
The development of new OECD Test Guidelines for specific tests involving biologicals/GMO may help to reduce the use of area of expertise No. 9 – “Other, specify”. However, the OECD Working Group of the National Coordinators of the Test Guidelines Programme (WNT) is responsible for the development of Test Guidelines, not the OECD Working Group on GLP.
Biologicals/GMO can be listed in the table indicating the scope of a national GLP compliance monitoring programme and it is not necessary to create additional areas of expertise for one product type.
The OECD Advisory Document No. 14 – “The Application of the Principles of GLP to in vitro Studies”- is very comprehensive and applicable to biologicals/GMO. The revised OECD Advisory Document on the Characterisation of Test Items – currently under development – will also address some specific aspects of biological test items.
