GDP -WHO guideline ) | , ) mccQ FEB-2017 SANOFI TAI LIEU THAM KHAO 4- Huéng dan trién khai thu hanh tét san xudt thude (Ban hanh kém quyét dinh 3886/2004/QD-BYT ngay 03/11/2004 cia B6 Y té) 2- Annex 2 WHO good manufacturing practices for pharmaceutical products: main principlest WHO Technical Report Series No. 986, 2014 3- Guidelines of 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) 4- Annex 5 : WHO good distribution practices for pharmaceutical products WHO Technical Report Series, No. 957, 2010 5- Technical Supplement: Qualification of temperature-controlled storage areas WHO Technical Report Series, No.961, 2011 ‘Annex 9: Model guidance for the storage and transport of time- and temperat ‘at Pharmaceutical products iperature-sensitive 6- Technical Supplement: Qualification of temperature-controlled vehicles WHO Technical Report Series, No.961, 2011 Annex 9: Model guidance for the storage and transport of time- and ter pharmaceutical products si *mperature-sensitive 7- NGUYEN TAC “THUC HANH TOT PHAN PHO! THUOC” (Ban hanh kém theo Théng tur sé 48 /2011/TT-BYT ngay 21 thang 12 ném 2011 cia Bé trximg 86NOI DUNG : PHAN |: NHAC LAI MOT SO NOI DUNG TRONG GDP PHAN Il: BANH GIA-THAM BINH SANOFI PHAN I; NHAC LAI MOT SO NOI DUNG TRONG GDP 4) TAILIEU 2) YEU CAU CO BAN CUA MOT CO SO 3) BAO QUAN-KIEM SOAT NHIET BO 4) SOAN HANG-DONG GOI-VAN CHUYEN 5) KIEM SOAT THAY DOI 6) QUAN LY SAI LECH SANOFIat DOCUMENTATION-TAI LIEU CHAPTER 4- DOCUMENTATION 44 Nguyén tac Tai liéu 1a phan thiét yéu cla Hé viét ngain ngira nhiing s. cho Phép sw theo déi cti sudt qua trinh phan phdi thudc Guidlines of 7 March 2013 on Good Distribution Practica of Medicinal Producta for Haman Use Jauitrinn spe Vu ang 3 ain \ \ \ee roe 7 (Record) \ \ adnate conti HO so oe yeu (D3 2) théng chat lung. Tai liéu ‘ai St khi giao tiép bang loi ndi va a Cac hoat dong lién quan trong (201570 60701) VAI TRO CUA TAI LIEU Huding dé (nstucios) > Chung ta phai lam gi (What we have to do) | Chiing ta phai lam diéu do nhu thé nao (How we have to do it) | Ho So(Records) Cai gi da that su xong (What was actually done) Diéu 46 da lam nhw thé nao (How it was done) Ai da lam no (Who has done it ) _Where —WhenQUI TRINH GOOD DOCUMENTATION PRACTICES — THIET KE QUI TRINH Ro rang, chinh xac, théng nhat va khong mo’ ho St dung ngén ngir cho moi ngwoi hieu duge Ay y ao * Higu MP “Gd tv y =" i$ Tai ligu t6t > thc hanh tot Good Working Documents > Good Working Practices e Duyét SANOFI GOOD DOCUMENTATION PRACTICES QUAN LY HO SO’ GHI CHEP Doc can than va suy nghi tro khi viét & Hoan thanh mét cach thich hop ~ Xem xét va kiém tra dé dam bao chinh xac e Stra l6i néu co 6 Rduay bik xat uct dds? >) Lwu gif? va bao quan an toan SANOFI.2/10/2017 TAI LIEU-QUI TRINH CHUAN (1) Ban hanh & quan ly tai ligu (SOP of SOP's) Quan ly nhan sw/dao tao (Personnel management including training) Sire khée va vé sinh ciia nhan vién (Health and hygiene of personnel.) Qui dinh ra vo kho & an toan lao dng (Access to the premises and their protection) Bao tri va vé sinh nha xwong, trang thiét bj (Maintenance and cleaning of the premises and the equipment.) Kiém soat cén tring (Pest control.) Higu chuan cac thiét bi theo déi, kiém tra va do luong (Calibration of monitoring, controlling and measuring devices) ~ TAREIEU-QUI TRINH CHUAN (2) Xtb ly khi-cé sy cé bé vo (bao gém ca thuéc déc tren té bao) {Handling of spillages (including cytotoxic products). [Xu ly'rée tl Hé6 théng vi i (Handling of destruction of waste) h (Computerized systems). Xtr ly hang tra vé (Handling of return products), Quan ly Khiéu nai (Complaint management) Quan ly sai Igch (Deviation management) Thu hdi (Recall) X@ ly hang gia (Handling of counterfeit products). Tadm dinh (Qualification and validation)‘ALLIEU-QUI TRINH CHUAN (3) Ty thanh tra ( Self inspection). Kiém soat thay déi (Change control) Tiép nhan (Receipt of product.) Bao quan’(Storage of products.) Biét triv, cho phép xuat va tir choi (Quarantine, release and rejection) Xw ly don hang (Order processing). Soan hang, déng géi va giao hang (Picking, packing and delivery) Xw ly nhéeng hang héa phai bao quan theo nhing qui dinh riéng biét ( Thudc déc nghién, huéng than, hang lanh...) Handling of special products (narcotics, cytotoxic and cold chain). SANQE co'so_ NHUNG YEU CAU CO’ BAN Hé théng an ninh Chae chan Anh sang phu hop (3733/2002/QD-BYT : ban hanh 21 tiéu chudn v6 sinh lao dong, 05 nguyén téc va 07 thdng sé v6 sinh Cé cc khu vue riéng biét-cach ly Kiém soat sinh vat gay hai Sach sé Kiém soat nhiét 46 Theo déi nhiét (4m) 46 Cac thiét bi do lwéng phai dugc higu chudn Cé ngan cach gita khu wy tiép nhan va cdp phat SANOFI.CAC HOAT DONG & QUI TRINH CHINH @ Tiép nhan @ Bao quan — Kiém soat nhiét (Am) dd @ Soan hang & giao hang @ Van chuyén @ Kiém soat thay déi ®@ Quan ly sai léch @ Anh gid va thém dinh @ Hoat déng dan nhan/dong goi SANOFI. BAO QUAN - KIEM SOAT NHIET DO Lam sao nhan dang duoc diéu kién bao quan? Mét s6_gidi han nhiét dé én Nhan bdo quan | Ue : : » Deep Frozen -70°C, ( Trén phiéu giao hang Poultry vaccin -cac vAc- xin co sl dung tring ga CO phdi dé nudi cay) > Frozen, -20°C (mot vai vac-xin ) > Cold, 2-8°C, e.g. insulin, hau hét vaccines, prostaglandin > Nhiét d6 phong , 15°C - 25°C /<20°C /<25°C/ ec <30°C ... Trong hé théng quan ly bang phan mém ERP (Enterprise Resource Planning) SANOFIKIEM SOAT & THEO DOI NHIET BO / THEO pol AM BO C6 nhiéu cach theo doi : Theo déi thu céng Kho (lap dat cdc dau da), hé théng ghi nhan ty dong building automation system JAS pulicing aulomavelsysein, ; : — , it Data loggers, bang dinh bao déng déng bang hay néng sanori Pd chain (hang lanh): theo ddi lién tuc BAO QUAN KIEM SOAT & THEO DOI NHIET AM BO/XU' LY VUOT GIO! HAN BAO QUAN ® Xac dinh gidi han vuot @ Bao déng/ gidi han canh bao phai xac dinh @ Théng bao cho bé phan chat lvong, tién hanh qua trinh sai léch diéu kién bao quan © Biét try san pham e Anh hudng cla viéc sai léch diéu kién bao quan phai dugc danh gia boi ngudi cé tham quyén © Quyét dinh : san pham cé thé © Ra khdi biét tri? va cho phép xuat e Tw chdi va huy bd —e Piéu tra vé nguyén-nhan gay sai-éch SANOFI 9SOAN HANG & DONG GOI + Chuan bi phan phdi cac loai san pham dén da khach hang theo don hang yéu cau + Dam bao chat lwong san pham duoc duy tri trong sudt hoat d6ng (dting san pham, dung so luong, tinh toan ven cua san pham, han su dung, ngan ngwa su hu hong va sai léch, nhiét d6, am d6, bao vé va nhan dang céc san pham co diéu kién bao quan dac biét ) or SANOFI VAN CHUYEN CONTAINERS THU DONG (PASSIVE) VA CHU BONG(ACTIVE) NHIET DO Thung carton Thu aor Thung cach nhiét voi da kho - Ing) - cc Pallet co thing chup Xe co diéu hoa Container chuyén hang co diéu hoa vai phan hang bi hu’ SANOFI 9 SAI LECH(2) Xem xét & phan tich, + Hang quy xem xét | sai léch va thyc | + Trong vong 30 ngay hign CAPA + Bao cdo chinh thitc Mi nam danh gia bdi Quan ly chat higu qua cla he wong théng quan ly sai Hanh déng khac Déng hi so’ sai léch phuc & phong ngira (Corrective & Preventive Actions capa) pe ra va thyc hign CAPAPHAN II: DANH GIA-THAM DINH SANOFI KHAI NIEM dén hiéu qua mong muén * L&8 hoat déng ching minh rng tat cd co sé, hé thdng va cac loai thiét bi da hoat dong dung va dua ta nhan dug da xac dinh trudge. «+ 3 mot chuong trinh durge chiing minh bing ho so gu nhim dam bao chdc chan rang céc qua, trinh, phutong phap hoc hé théng cy thé luon juon dua dén mot két qua dat cac tiéu chuan chap btu SANOFI3 2 cae bud. viDU SANOFI DANH GIA TRONG PHAN PHO! minh ching dap ic sau: “Xe din teu chun (cong suat may lanh, vit bé ti.) << 7 — “Kid ira tin ch vat tu cong ut may, vp at.) va cae Giay chvng nhan * Banh gia dd Ging déu nhiet do kho tréng a kiém ta 46) = . ‘ 7- Mau bao cao danh gia 8- Nhieng phu luc dinh kém, poi. ca nhieng mau cho bao cao danh gia SANOFI 7MAU DUYET DE CU'O'NG VA LICH SU’ KIEM SOAT THAY BO! Nye i bien soan: | ‘Anban- Noa Meta thay 481 Pe aad SANOFI J 2- HUONG DAN CACH DANH GIA DO DONG DEU NHIET AM DO ; 2.2 NOI DUNG CUA DE CU'ONG DANH GIA: 6- PHU'O'NG PHAP TIEN HANH Buc 1: Chon thiét bj do dya trén diéu kién bao quan, (nbn 0 han ge) Buc 2: Lap_ddi tién hanh danh gia . Luén dam bao ting thanh vién hiéu ro trach nhiém va dugc dao tao. Buc 3: Khao sat co so’: kich thuéc kho, cdu tric ké, vj tri ké va hang hoa, luéng hoi lanh, vi tri may lanh, vj tri cua cac dau do co san. Buoc 4: Thiét lp gidi han chap nhan. ie 2a w: Tat ed cab dite uke faa Kan 1 | SANOFI INDONG DEU NHIET AM pO 2.2 NOI DUNG CUA DE CU'ONG DANH GIA: 6- Phuong phap tién hanh (TT) Buc 5: xac dinh vi tri do -Theo khéng gian (dai, réng, trén, dwoi, truvec ,sau): moi thiét bi do cach nhau tt 5-10m -Chiéu cao < 3.6m: thém diém gitra vi tri cao va thap nhat (vd: san, 1.2mva 3.0m) 92» -Chiéu cao > 3.6m : diém chon trén, duoi va gitra khéng gian . Khoang cach cho kho cao 6m thi chon 3 diém 1.8m,3.6 m va 5.4m | -Cac vi tri nguy co: Goc ¢ ting, khu vue gan cira, khu vw gid ra gid vao, ... SANOFI 9 Vi DU MINH HOA DAT CAC THIET BI BO (1) 1-Typical location of data loggers in a pallet racking storage area Figure 1- asl pase a | Bar2- HUONG DAN CACH DANH GIA DO DONG DEU NHIET AM DO : 2.2 NOI DUNG CUA DE CUONG DANH GIA: 8- Phuong phap tién hanh (TT) Buoc 5: xac dinh vi tri do -Theo khéng gian (dai, rong, trén, dui, truéc ,sau): Oi thiét bj do cach nhau ti 5-10m -Chiéu cao < 3.6m : them diém giira vi tri cao va thap nhat (vd : san, 1.2 m va 3.0m) -Chiéu cao > 3.6m : diém chon trén, duéi va gita khéng gian . Khoang cach cho kho cao 6m thi chon 3 diém 1.8m,3.6 m va 5.4m -Cac vi tri nguy co: Gée twong, khu vuc gan cira, Khu vuc gio ra gid vao, ... SANOFI J Vi DY MINH HOA BAT CAC THIET BI BO (1) Figure 1 - Typical location of data loggers in a pallet racking storage area ee | SANOFI.Vi DU MINH HOA DAT CAC THIET BI BO (2) sheen 2p ct dt lg ina aio 0m SANOFI Vi DY MINH HOA DAT CAC THIET BI BO (3) 1 HOA BE ve Te een suo of 15m 099 re Pagar Te png 0 SINCE ‘inensona SANOFIVi DU MINH HOA BAT if j : CAC THIETBIDO(4) 7 - Vy sc: Laat é jefe eee? UPL HUONG DAN CACH DANH GIA DO DONG DEU NHIET AM DO 2.2 NOI DUNG CUA DE CUONG BANH GIA: 6- Phwong phap tién hanh (TT) Buc 6: hd so” thiét bi do dugc ghi r6 vi tri ting cai trong bao cao va ca thiét bi dieu nhiét. Buc 7: Hoat dong dan nhan nhan dién va cai dat t bj do, thuong tan suat do tir chuwong trinh cho thie 5-15 phutilan (6 lan/ gid), cai dat cac thiét bi do bat dau hoat déng cung 1 thoi gian Buc 8: Cé dinh cac vi tri cua thiét bi do theo so dé. Luu y cac thiét bj do phai doc co dinh chac chan va khéng bj anh huong boi cdc hoat dong khac. SANOFI J_ HUONG DAN CACH ANH GIA DO DONG DEU NHIET AM DO 2.2 NOI DUNG CUA DE CUONG ‘pANH GIA: 6- Phuong phap tién hanh (TT) Buc 9: tién hanh do. Nhding kho bao aks kign thuéng phai duge tham dinh, toi th 0) than sé series cua thiet Bj ngay lien tue. Kiém tra can do khi viet ‘bao cao. Buoc 10: truy xudt dé ligu va phan tich./ 3) te dik, mi bucorry Je, yea C3 A dasa logger SANOFI HUONG DAN CACH DANH GIA BO DONG BEU NHIET AM BO 2.2 NOI DUNG CUA BE CUONG BANH GIA: 7 -BAO CAO BANH GIA BQ DONG BEU: 7.1 Gi6i thigu: mé ta myc dich cua viée danh gia 7.2 Tang két: tom luge va thao Juan vé két qua da thu duoc sau tham dinh, bao gom ca nhivng sai lch (néu 6) 7.3 Két luan va khuyén cao: két luan chung cho tat ca nhiing thdm tra va quan sat chi ra sw chap nhan cdc thiét bi cho hoat dong. Co thé dua lun cac khuyén cdo va nhan xét. hy bet Bred dom rede Hei, SANOFI 24HUONG DAN CACH BANH GIA DO DONG DEU NHIET AM DO =a 2.2 NOI DUNG CUA DE CUONG BANH GIA: 7- BAO CAO BANH GIA BQ DONG DEV 7.4 Cac phu luc clia bao cao: | = - So dé khao sat, chi r6 cac vi tri dat thiét bi do ~ Di ligu thé - Bang tinh toan cua di ligu va cac | biéu dé nhiét d6 cua tirng thiét bi do - Nhieng tai ligu va ghi chép chinh | chuan bi trong qua trinh thyrc nghiém, cung voi bat ky cdc tai ligu hé tro khac. = Cac bao cao sai Iénh, cac hanh dong khac phuc phéng ngira (CAPA) néu co = Gidy cheng nhan higu chuan cia tat -ca cdc thiét bi do. ——____——— SANOFI BAO CAO VI TRI DAT THIET BI DO DL-001 0123456TH 1 03 DL-002 0123456TH 2 28 DL-003 D123456TS 3 54 SANOFIBANG THONG TIN HE THONG DIEU HOA (NHIET &AM DO) | Vitri Nhiét 46 cai dat Ghi chu aravaosét [4c \ Gan clraravaos62 [| 4°C L SANOFI J BANG PHAN PHOI NHIET DO co | khén DL] 34 63 5.6 v NAN 22.07.2016 001 SANOFI ®HU'O'NG DAN CACH DANH GIA DO DONG DEU NHIET AM BO 2.3 TIEN HANH THU'C NGHIEM DO Tién hanh thc nghiém theo dung dé cong. Dam bao cac nhan vién dang lam trong kho déu duge chi dan dé kh6ng v6 y lam ngung hoac tat thiet bi thuc chu ky do, thu gom tat ca thiét bi, tat va tai dir ligu de phan tich. SANOFI J HUONG DAN CACH DANH GIA DO DONG DEU NHIET AM DO 2.4 PHAN TICH DU LIEU VA CHUAN BI BAO CAO DANH GIA 2.4.1 Phan tich ban dau Phan tich toan dién d6 6n dinh nhiét d6 cua khu vuc nghién ciru va dinh ro murc dO bién déi xuat hién. So sanh két qua do duge voi gia tri chap nhan. Nén lwu y cac yéu to sau: - Kha nang cua hdéng diéu héa nhiét dé duy tri nhiét dé trong gidi han cho phép -Su 6n dinh nhiét d6 cua khu vyc dang dugc theo doi, va bién do trong dao dong dién ra sudt thoi gian nghién cru. SANOFI oyTS HU'ONG DAN coe on GIA DO DONG DEU NHIET 50 suANE| Bho 2.4 PHAN TICH DU’ LIEU CAO DANHGIA _ 2.4.1 Phan tich ban dau dieng va chiéu fy thudc vao kich thuée cia khu ve, cach phan b6 thiét bi do, - Sy thay déi nl nhieng khu vue gan voi hong gid , so sanh voi nhieng khu vc xa hong gi HUONG DAN CACH DANH GIA BO DONG DEU NHIET AM DO 2.4 PHAN TICH DU’ LIEU VA CHUAN BI BAO CAO DANH GIA 2.4.2 Diém cao nhat & thdp nhat Sy danh gia d6 déng déu nhiét dé do lvong deo dong 9, Sy phan tich dir ligu dua ra nhiét 46 cao nhat & thap nhat trong khu vuc. Nhiét d6 cao nhat & nhiét 46 trinh danh gid c6 thé vuot ra ngoai gioi han chap nhan iém néng nhat (noi nhiét dé cao nhat) va lanh nhat (noi nhigt d6 thép nhat) thi phai nam trong gidi han. Muc dich cia viée xc dinh diém cao nhat va thap nhat la xae dinh nhiing vi tri dé dat cac thiét bj theo dai, Dim ong va diém lanh can xac dinh theo mua va ching co thé khac vjtri. thap nat ghi nhan suét qua SANOFI 9. Ady, 28HU'O'NG DAN CACH DANH GIA DO DONG DEU NHIET AM BO (8) 2.4 PHAN TICH DU’ LIEU VA CHUAN BI BAO CAO BANH GIA (TT) 2.4.3 nhiét 46 déng hoc trung binh C6 thé str dung két qua danh gia nhiét do dong hoc trung binh dé phan tich dip li¢u khi thay co div ligu khong én dinh ( vd bién déi theo hinh sin hoac co dinh vugt trong thoi gian ngan) . Tuy rat co ich trong viée danh gia két qua nhung cling khéng thé bo qua dir liéu that vi no co thé tiét 19 nhieng diém vot qua bién d6 nhiét qui dinh. SANOFI . HUONG DAN CACH DANH GIA DQ DONG DEU NHIET AM BDO (8) 2.4. PHAN TICH DU? LIEU VA CHUAN BI BAO CAO DANH GIA (TT) Khai niém MKT (nhigt 46 d6ng hoc trung binh) MKT cé thé duc xem 1 mot nhiét 46 bao quan dang nhigt mo phéng su’ thay ddi nhiét 46 bao quan khéng dang nhiét Céng thitc tinh = AH/R he . + eOWR y+ @OHIRTE eee oe TE nhiét 46 d6ng hc trung binh AH: nhiét cla sy’ hgat héa, 83.144K) mole R. : Hing sb khi trung binh 8.3144x10 9k) mole “T, : nit 46 ghi la trong gial dgan 2 “Ty-rnhit 46 ght tat trong iat doar 2———— SANOFI 3 To : nhiét 46 ghi lai trong gia dan n (tinh bang 46 Kelvin-K)POngdnnnii SANOFI Po HUONG DAN CACH DANH GIA BO DONG DEU NHIET AM DO 2.4 PHAN TICH DU’ LIEU VA CHUAN B| BAO CAO BANH GIA 2.4.4 Phién dich két qua va dura khuyén cao *Cho thich sw léch nhiét 6 trong khong gian quan sat dugc sau khi lvu y dén do lech cua thiét bj *Sw dung cac phan tich dé ligu 46 danh gia sy én dinh nhiét dé toan dign co lien quan dén gidi han chap nhan. =Danh gi sy én dinh ca ludng khi néng cua khong gian nghién cau voi sy lién quan dén nhigt 49 cao nhat va thp nhat ghi nhan *Danh myc cac yéu té anh huéng dén sy thay déi nhigt tri gan hong gid hay gan civa, chiéu cao hang =Danh gia sy nhat quan & khong nhat quan trong sy l@ch 9, sy bién déi trong khu vye Iwu tro. No)on 7 : . HUONG DAN CACH DANH GIA BO DONG BEU NHIET AM DO 2.4 PHAN TicH DU LIEU VA CHUAN BI BAO CAO DANH GIA 2.4.4 Phién dich két qua va dua khuyén cao ~Dya vao sw thay déi nhiét d6 cia cac vi tri, khuyén cdo khu vue co thé Iuu trir cac san pham nhay cam nhiéu va it nat. *Dwa vao sw thay ddi nhiét 46 cua céc vj tri, khuyén cao CAC Vi tri dat thiét bi theo ddi ghi nhan nhiét d6 va cdc Sensor kiém soat hé théng lam lanh. 2.4.5 Kiém tra lai bao cao Néu trong néi bé : can phai co mot ngwoi kiém tra lai toan bé bao cao, xc nhan, duyét va ky ten Néu str dung dich vu, phai c6 mét ngudi co thim quyén duyét. SANOFI HUONG DAN CACH DANH GIA DO DONG DEU NHIET AM DO j ; 2.5 THYC HIEN CAC KHUYEN CAO TRONG BAO CAO DANH GIA Két qua cuéi cing va muc dich ctia vige danh gia do dong déu_ la thue hién cac khuyén cao trong bao cdo tham dinh. Cac khuyén cao nén bao gém cac két qua sau day: "So dé cho thay cac san pham duge an toan & vi tri da duoc danh gia (vd: 1 san pham khéng bi anh hwong boi nhiét dé gay dong bang c6 thé dé & kho Janh noi vj tri c6 nguy co’ xuéng. nhiét d6 dong) *Phan chia cac pallet trén hé thong kho dé kiém soat cac vi tri SANOFIHUONG DAN CACH DANH GIA BO DONG DEU NHIET AM BO cho pant iA 2.5 THU HIEN CAC KHUYEN CAO TRONG BAO AO DANH GIA spat lai cac diém theo doi nhigtam do : *Chinh lai cac déng hoi lanh dé giam sv phan tang Thiet dé. varhode tai giam cac diem lanhy va nong Nang cap hé thong may dé cai thién kiém soat nhiét do va higu nang. *Quyét dinh sir dyng khu vyc nao cl voi hang hoa. hia dé phu hop SANOFI) BANG TOM TAT LICH SU’ THAY BO! I Thay ik ide Mt tae ih Pact SANOFI 2ro/rgy 32THEO DOI NHIET AM BO BAO QUAN HE THONG CANH BAO NHIET AM DO - : NGOAI GIO! HAN Lap dat hé théng canh bao nhiét 4m dd ngoai gidi han trong kho theo cac yéu cau sau +D6 léch clia dau dé hé théng canh bao (HTCB): 46 khéng qua +0.5°C ( am d6 +5%). ; *Dau dé HTCB duoc higu chudn dinh ky , it nhat 1 lan/nam e -Dau dé HTCB dugc dat tai vi tri “te nhat” theo két qua danh gia dé déng déu, néu dau do khong lien két duoc voi cac thiét bj do cla kho thi phai dat ngay sat vi tri thiét bi do. +Ddu dé HTCB dat © vi tri bj anh huong it nhat boi nhieng anh hwéng nhat thoi nhw gan cira mo SANOFI => DANH GIA PHU'O'NG TIEN VAN CHUYEN & THAM BINH QUA TRINH VAN CHUYEN =Tace Aidn ver do tnt dec bed SANOFI 9 Eeri Nhiét dé hoat dong Gio han hién thi cé thé quan sat YEU CAU CUA THIET BI DO BIEN TU’ CHO VAN CHUYEN — G Gidi han : -10°C dén +55°C io} han : -20°C dén +55°C BO chinh xac nhiet 46 | BO chinh xac vé thei gian Khoi diém muén +0.5°C hode tét hon trong khodng - 8°C dén +25°C, £1°C trong khoang -20°C dén -5°C va +25°C dén 455°C £10 gidy/ngay , hoc tét hon th Thoi han ghi nhan itnhét 10 ngay | Pin tich tror tec khi START [Dor lieu twu git sau khi STOP It nhat 18 thang it nhat 06 thang hein ding Pehuayon. NEL thoy gt vas Bets Hacc! od dé SANOFI. VI TRi DAT THIET BI DO TRONG CONTAINER NHIN TU TREN XUONG i. & DUBE his hy;VI TRI DAT THIET B] DO TRONG CONTAINER NHIN TU’ CAT NGANG 1) osulated container: side view ee — Ea | SANOFIV| TRI DAT THIET BI DO TRONG CONTAINER NHIN TU’ CAT NGANG by towulatedVi DU: KET QUA THAM BINH QUA TRINH VAN CHUYEN SANOFI —> Ve; Xe ahd a xad diol i fs! ngug af dé at PAA dy THANKS FOR YOUR ATTENTION AND PLEASE DON’T ASK TOO MUCH SANOFI whee p fa