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IVA PHARMA sac Riva pharma ‘Anise 45 52 pul Film coated tablet 15a! Js for amoxicil ail (at yl 9354 + trihydrate cintrent pharmaceutical for mix of potassium clavulante fermic mexico Fou el COMA eghad ¢ fl se yl Oe 99 V2 sey Shad G55 3) eel (GIT ast JS Oa Alay Aa 4 sth 12000 unit and each unit 7 sssa.sls tablet 1500 S50 hy pal a 4 th 4. unit and each unit is 7 tablet (pilot) yy Ay pyc BOX ID: 847/425ET Rae cha glee oy Rivaclav 1000 mg FCT: pastuall al @ . Riva pharma amoxicillin trihydrate and Mail lst! yl) potassium clavulante . sh hp fl i pot ASI ple imported (elm . 128.94kg ahs Salssy! ati 4, pall ASI) © t62t7hg aida pilldanl LGA 425 2 133 oy Riva pharma Shi 4 Lal Se Vertes Gumeeaaguea Ss re ehcidda peat) Sy pal at gost 6 ae ae a Bgl SSE psy etal aS Sal eseonz tall in RIVA PHARMA(siaall pet bs al are Model and serial sud oes a Wax] Ofmachineused | tastusy | SEV EshAN | Ay 105 KG 30-08 Mer Ming 7 KG 305 double cone $00] Model:0S-¢M) FITZ MILL | Wwiling z ke/hour Serial no: 330501/06AF339 Code 80-01 Scanned with CamScanner 30,000/hr] 75,000] Code :BD-06] CADMAC | Compression ¥ tap/hr| — Model CMB4- | compression RIW 27| machine Serial number : E 701088 75 kg 150k¢ | Code: BD-04] Ganson Coating z Serial number 358 Model: Gac-1200 =| 6000/hr | MODEI: HOONG-A| — Blistering > HOONG_A Code 80-05 Serial no: VAL/M50150 500] 2000 box Serialno:| HITACHI | _Boxover v box/hour Tnour | 8Rx02324611 printing Code: BD-17 Model: BRXDASOW = ‘Model:FR8-7701 | FRB-7701| Alum pouch 7 20 unit per Serial no: sealing min | 111115050870 Code BD-20 2000/hour | 10000/hour Code:e014 | 2E-Sbi4 Leaflet 3 Serial no; folding Model :ZE-9b14 tid pall ote DN Syria gle Gisela ya (1 (lh lal Spall gh Jal Cl penninall Jn A) Jal el Mlilya (2 BLA papell SEI y Wall LL GUL! 4: cada ye Qsinadl) sie Gale) ll gol Ghai Wa i ginal de (3 (Asses Ale CY ae GS oly (4 Report from R&D department which include CPP (critical process parameter) (5 Deseri Manufacturing Proce: ‘control which should include (6 Flow diagram giving the steps of the process and showing where material enter the process, the critical steps and points at which process controls. ‘A narrative description of the manufacturing process. Environmental conditions (temperature and humidity) * For the manufacture of sterile product the class of the area should be stated for each activity. gh bay AS ntl patty Uses le ydaynie Lista Gl gladly Gilt g) Sh le Wl SA CD yy pl a as NA) Da i gill) le Lisl 51 2G) 5 Soe) CALLA GE AME lal tay GV) giles gle UMsil syl ks! Scanned with CamScanner

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