GLP studies on biologicals/GMO test items that are currently performed in accordance with the OECD Principles of GLP can be assigned to one of the existing nine areas of expertise, as defined 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.
These areas of expertise are of a general nature and can be used for many product types (e.g. industrial chemicals, pharmaceuticals, plant protection pesticides etc.). In general, a product type will not have a specified area of expertise.
The existing areas of expertise are therefore sufficient to also describe studies conducted using biologicals/GMOs which may be either in vivo, in vitro or concern environmental toxicity, behaviour in the environment or bioaccumulation. There may also be GLP studies on safety testing of biologicals/GMOs (e.g. of gene therapy medical products).
The area of expertise No. 9 – “Other, specify” is being increasingly used to specify study types in connection with molecular biology, genetic engineering or GMOs (e.g. cell-based systems for the detection of biological parameters, bioactivity testing, immunogenicity testing, patch clamp test, cell culture based biocompatibility test, test for microbial contamination, DNA sequencing for genotyping, etc.).
Biologicals/GMOs are a new test item type, albeit different to conventional chemicals, however GLP studies on biologicals/GMOs are neither a specific type of GLP study nor a specific area of expertise. They are no different to other “new” products such as nanomaterials or medical devices. It is therefore reasonable to regard biologicals/GMOs as just another product type.
