definiens: means the ( i ) raw material specifIcati.ons ( including approved suppliers, art pr.o.ofs, chemical, micr.o, and packaging specifIcations ) ; ( ii ) sampling requirements ( i.e., lab, chemical, and micro ) ; ( iii ) C.omp.ounding module, including c.omp.ounding process and maj.or equipment ; ( iv ) intermediate specifIcati.ons ; ( v ) packaging m.odule ( including packaging procedures, t.orque and fIll weights ) ; AQL 's ), as appr.oved in writing by COMPANY ; ( vii ) stability specifIcati.ons ; and ( viii ) test meth.ods . Specificati.ons shall be established and/.or ameoded fr.om time t.o time UP.on the written agreement of both [COMPANY] aod COMPANY via a Pr.oduct Change Request ( ) in acc.ordance with Secti.on IX bel.ow