definiens: or means those practices in the manufacture of pharm aceutical products that are recognized as the current good ma nufacturing practices, including, without limitatio n, each of the following as in effect on the Effective Date of this Agreement and as amended or revised from time to time thereafter : ( a ) the FDA Act, including 21 C.F.R. pa rts 11, 210 and 211, and other FDA regulations, pol icies and guidelines governing the manufacturing, testing, st orage and/or quality control of active pharmaceutic al ingredients for use in human drug pharmaceutical pr oducts ; and ( a ) all ICH guidance documents as appro priate, including EU Directives 2003/94IEC code of GMP and 2001/83IEC as amended by 2004/27 / EC code of practic e for the QP, and ICH Tripartite Guidance Q7A entitle d, as applied to active p harmaceutical ingredients for use in human drug pharmaceutical products