definiens: means, •• apphcable . those current, tices . lIS amellded from ti~ \a time, rdalro 10 the manufacture or phanna.:cutical products and any precllr.lOr.i thereto promulgated in guidelines and regulations of standllrd compilatinns including the GMP Rules of the World Health Organization, the United States Code of Federal Kegulatio.ns . the Guide 10 InSpfX : tion of Bulk I'hannaceutical Chefni ..,l . ( established by the United States Departmcnl of lIeahh and Human Services ), the Phannacc : ulicll Inspection ConY<)ntion, and the E~,, " Communi ty Guide to Good Manufacturing PJ.etiu to the produ<:tion of pharmaceutical prodllClS