West} PRODUCT SPECIFICATION Page 1 of 3 Catone: We Una ica 90 — i | St Serle pctgng (We pharracetcalpatagha he on hee on Gyhous eu [tured FLA 2 br 20 GA ghee? Stipe ey — sane ee ome eo 2018 oes Genre exertion -Desgraton aie inscan “Brn erga on; 8 om Ag on, Gracnre (ran ater evislon vised according to §8 InsoCap i a closure for infusion containers produced scoring to Bow-Fil-Seal procedure and thereat tobe classified asa secondary pacragig material InsoCap it produces and packed under ceanroom cass © 2, Raw Materials -HOPERP: Basel: Purel ACP 6541 of PURELL RP.270G or equivalent materi “PE ‘West Phamaceutal Senco Formulation 8588/45 A grey ‘orequvalent material cover Fo Top ayer: PET, ite lyer Aluminum, cap sided layer: posible 8. Beta on Production and Quay Contr “The above-mentioned tems produced in our Chinese locaton at Stanghal The general ‘roducton process of hem areas wel te quay cortvl measures are aozordance wi {he guidelines deserbed wn the current issue of quay manual 14. AQL Fina! Control ‘According othe guidlines of SO 2860/1 samples of each bac ae inspected agains tributes ‘a variables, A tnaings are docuentad in cur Cetieat of Analysis whch cotesponds tothe ‘West Detect valuation Uist (tachment 1) ‘Abalh wl ont be approve he numb of defects founds less thn or equal othe quantity ‘which gues on our Cetiieat of Analysis.West} PRODUCT SPECIFICATION Page2 3 'S. Packaging ‘Aces rom one ct are packed into LOPE bags (ateraiely tubular). Wher reaching Setermined quant of ploces, tbe bags are closed by woking abeld, packed lo ancter bag {der learroom eandons and closed wih a plastic lp. Caresponding nunbo of bape are aeked ino caren and esed with adhesive tape made of pape Pieces perearon: 3000 ‘Overal height ofthe palet 1650 mm |6. Labeling ach carton and imer PE bag are labled wih the folowing data ‘Name of 6000S" hem tthe *G000S" (County of one ofthe GOODS" Production da ‘Quanity ‘Baten number 7. Kind of inspection A) Visual Visulinspectons are performed wsh naked eye, wihout using magniying asses. Peet Force Peel Fore determined by hep of @ tense testing machine fra pul orate of 200 mm rn in e290 fn of Provided that custamer asceisins deviatons rom cur specication during incoming quality con, ‘we ky ask im send the following nraton the metre to fn the defects in question 2s wells the size of sample chosenor random Inspection = some samples ofgeoctiv closes (toppers), possible, “the batch number) forte batches) n question.West PRODUCT SPECIFICATION Page 8 of3 West pharmaceutea packaging China pant wal decde what actions tobe ikon ater stying ‘corde of fe retained eamles andthe sarpesrlumed y the customer and be Plan wil ‘Sboequntl lor the cusere fs decison ‘total eum ofthe concses goods mn queston can tke place ony ater West pharmaceutical ‘ackagig China pan has taken a dection according wo ths prosadue ls, In formula or production process ‘Changes in formula are only made upon custome’ request. ‘Changes mt production processes that atc he propaies of the atic as desorbed inthis Speceaton wa be advice at ast 60 days in aavance. 10.Customer's Specification ‘Specieion provided by the customer wil be examined by West pharmaccuteal packaging China Plant Incase West pharmacautea! packaging China pant approves customer's speceaton is comes valid together wih he presen specteaton, unless data ndeatd heroin i not ncluded in custome’ specication 11.Other agreements withthe customer Na