definiens: means the current good laboratory practice regulations promulgated by the FDA, published at 21 U.S C.F.R. § 58, and equivalent non - United States regulations and standards inthe Territory, as applicable, as such current laboratory practices, regulations and standardsmay be amended from time to time.1.8 means those current practices, as amended from time to time, related to themanufacture of pharmaceutical products and any precursors thereto promulgated in guidelinesand regulations of standard compilations including the GMP Rules of the World HealthOrganization, the United States Code of Federal Regulations, the Guide to Inspection of BulkPharmaceutical Chemicals ( established by the United States Department of Health and HumanServices ), the Pharmaceutical Inspection Convention, and the European Community Guide toGood Manufacturing Practice in the production of pharmaceutical products, and equivalentguidelines, regulations and standards in the Territory, as such guidelines, regulations andstandards may be amended from time to time