Lampiran 1. Peta Akses PT Aventis Pharma

Transkripsi

1 Lampiran 1. Peta Akses PT Aventis Pharma

2 Lampiran 2. Peta Lokasi PT Aventis Pharma

3 Lampiran 3. Struktur Organisasi Sanofi Group Indonesia President Director Executive Assistant National Sales, Director Head of Marketing & Oncoloogy Strategy Development and Diabetes Director Consumer Health Care Director Communication & Public Affairs Director Chief Financial Director Head of Commercial Exellence & Bussiness Dev Human Resources Director Medical & Regulatory Director Legal Director Plant Director General Manager Vaccine Country Compliance Officer

4 Lampiran 4. Struktur Organisasi PT Aventis Pharma (IA) Vise President Industrial Affairs, APJ Region Plant Director Executive Assistant IA HR Manager IA Controlling Head of Industrial Quality and Compliance Country Precurement Head Head of Logistics and External Manufactury Technical Service Manager Production Manager HSE Manager

5 Lampiran 5. Struktur Organisasi Departemen Industrial Quality and Compliance Head of IQC IQC Admin Asst. QC Supervisor QA Supervisor QC Foreman (for chemical) QA Officer QC Analyst QC Analyst QA Officer QC Analyst QC Analyst QA Officer QC Analyst QC Analyst QC Analyst QC Support Regulatory Site Officer QC Analyst QC Support

6 Lampiran 6. Contoh Label Pada barcode akan terlampir RELEASED, REJECTED, QUARANTINE dan SAMPLE TAKEN yang menandakan label pada SAP.

7 Lampiran 7. Alur Pemeriksaan Bahan Baku

8 Lampiran 8. Persyaratan Jumlah Bakteri, Total Koliform dan Koliform Tinja pada Masing-masing Jenis Air No Jenis uji Air sumur Air PAM 1 Jumlah bakteri Tidak ditetapkan 100 kol/ ml Portable water 100 kol/ ml Purified water 100 kol/ ml MiliQ- Plus 100 kol/ ml 2 Total koliform < 10 0 kol/ 100 ml 0 kol/ 100 ml Koliform tinja kol/ 100 ml - - Keterangan: 1. Air sumur adalah air yang diperoleh langsung dari sumur artesis tanpa pengolahan awal. Air sumur diperiksa setahun sekali 2. Air PAM adalah air yang berasal dari olahan PAM city water. Air PAM diperiksa cemaran mikroba seminggu sekali dan sebulan sekali untuk diperiksa keadaan kimia dan cemaran mikroba. 3. Potable water adalah air yang diperoleh dari pengolahan air sumur/ PAM. Potable water diperiksa cemaran mikroba seminggu sekali dan sebulan sekali untuk diperiksa keadaan kimia dan cemaran mikroba. 4. Purified water adalah air yang diperoleh dari pengolahan potable water dengan cara deionisasi, reverse osmosis, polishing (mixed bed procedure), elektro-deionisasi, atau kombinasi reverse osmosis dengan elektro-deionisasi. Purified water diperiksa seminggu sekali. 5. Purified water MiliQ-Plus adalah air yang diperoleh dari hasil pengolahan purified water dengan alat MiliQ-Plus untuk keperluan analisa di laboratorium. Purified water MiliQPlus diperiksa seminggu sekali.

9 Lampiran 9. Skema Purified Water Plant

10 Lampiran 10. Alur Penanganan Limbah 142

11 Lampiran 11. Skema Waste Water Treatment Plant Office building, security, packaging, warehouse, kantin, dapur Main Purpose Building Production, Purified Water Antibiotic waste Collecting pit 1 Collecting pit 2 Collecting pit 3 Perforated bath stream Equalization tank Aeration tank Sludge Sedimentation tank Water Sludge tank Clean water tank +hipoklorit Sludge drying bed Dry sludge Effluent/ water River Connect to WWTP operator room for sampling purposes PPLI 143

12 Lampiran 12. Denah Warehouse

13 Lampiran 13. Daftar produk PT Aventis Pharma Actonel 35mg Daonil 5 mg tab TH 10 x 10' Amaryl 1 mg 3x10 VN (SA) Daonil 5 mg tablet 10 x 10 Amaryl 1 mg 5x10 Daonil 5 mg tablet MAL 10 x 10 Amaryl 2 mg 3x10 VN Dermatop Cream 15G (SA) Amaryl 2 mg 5x10 Dermatop Cream 5G (SA) Amaryl 2 mg VN (3x10') Esperson Cream 15G Amaryl 3 mg 5x10 (SA) Esperson WO 5G (SA) - NEW Amaryl 4 mg (3 x 10') (TH) Favirab Amaryl 4 mg 3 x 10' SA Fexotabs 120 mg 50 TAB Aust-USA Amaryl 4 mg 3x10 VN Fexotabs 120mg 30TAB AUST - USA Amaryl 4mg 3x10 (TH) Fexotabs 180 mg 10 tabs AUST-USA Amaryl M 1 mg 3X10 Fexotabs 180 mg 50 Tablets (AU-UK) Amaryl M 2 mg 3X10 Fexotabs 180mg 10tab Aust-UK Amlogrix 10mg Fexotabs 180mg 30TAB AUST - UK Amlogrix 5 mg Fexotabs 180mg 30TAB AUST - USA Atorwin 10 mg (3x10') Fexotabs 180mg 50TAB AUST - UK Atorwin 20 mg (3x10') Fexotabs 180mg 50TAB AUST - USA Avaxim 160U Adult Fexotabs 60mg 20TAB AUST - USA Avaxim 80U Adult Flagyl 0.5 gr Suppository-OM Avaxim 80U Pediatric Flagyl 1 gr Suppository-OM Avaxim Adult Flagyl Forte 500 mg 1' Physician Avil 45,3 mg 50 Tab (SA) Flagyl Forte 500 mg tablet 10 x 10 Avil 45.3 mg x 50 tablet Flagyl Forte 500 mg tablet PH Avil tablet Flagyl O.S 60 ml Aziwin 250 Flagyl OS 60 ml Aziwin 500 Flagyl OS 60 ml Philipines Batrafen Cream 10 g Flagystatin Ovule OM BGStar Starter Kit mg Flagystatin Ovule SG BGStar Test Strips x50 Flagystatin Ovule Philipine Cardace 10 mg Fludara tablet Cardace 10 mg 30'S(TH) Fludara injection Cardace 2,5 mg 6x10'(askes)-1 Frisium Tablet Cardace 2.5mg TH Glibenclamide 3 x 10 (PH) Cardace 5 mg Grocery Pack Of Telfast 120 mg AU Cardace 5 mg 30 TH Grocery Pack Of Telfast 60 mg Au Cardace 5 mg 6x10'(askes)-1 Imogam Rabies Coaprovel 300 mg/12,5 mg Imovax Polio Co-Irvebal 150 2X14 Insulin Human Comb 25 Co-Irvebal 300 2X14 Insuman Basal 100UI Cordarone (Sanofi) Insuman Basal 100UI for ASKES Daonil ( PH ) ( 10x10' ) Insuman Human Generic

14 Insuman Rapid Solosa 1 mg 5 x 10 Insuman Rapid Generic Solosa 2 mg 12 x 10(TH) Irvebal 150 2X14 Solosa 2 mg 5 x 10 Irvebal 300 mg Solosa 3 mg 12 x 10 (TH) Jevtana 60 mg Solosa 3 mg 5 x 10 Lancets x 50 33G Solosa 4 mg 3 x 10 Lasix Tablet Stilnox 10 mg tablet 2 x 10 Loprox Nail 1.5 G Synvisc Lovenox 2000 anti-xa IU/0.2 ml Synvisc One Lovenox 4000 UI - NEW Taxotere 20mg Lovenox 4000 UI - NEW (ASKES) Taxotere 80mg Lovenox 6000 anti-xa IU/0.6 ml Telfast 120 mg 1 x 10 ' HK Lovenox 6000 UI - NEW (ASKES) Telfast 120 mg 5 x 10 ' HK Metronidazole Telfast 120 mg 5 x 10 ' PH Novalgin 500 mg tablet 10 x 10 (SA) Telfast 120 mg (2 tab) AUST (SA) Novalgin 500mg 50x10 (SA) Telfast 120 mg (5 x 10') AUST (SA) Novalgin Drops 10 ml New Telfast 120 mg 10 Tablets Novalgin Syrup 60 ml Telfast 120 mg 30 Tablets Orudis E x10 (PH) Telfast 120 mg 30 Tablets Orudis E-100 tablet Telfast 120 mg 5 Tablets Pediacel 0.5 ml Telfast 120 mg Grocery Platogrix (2x14) Telfast 120 mg NZ-UK Plavix Telfast 120 mg Phil Pneumo 23 Telfast 120mg (1x10') AUST - SA Proctosedyl Telfast 120mg (1x10') AUST - SA Proctosedyl Suppo (MAL) Telfast 120mg (1x10) SG Profenid 100 mg Supp (SA) Telfast 120mg (3x10') AUST - SA profenid CR 200 Caps (SA) Telfast 120mg 10TAB AUST - USA Profenid E-100 tablet 10 x 10' (SA) Telfast 120mg 10tab NZ-UK Profenid Gel 30 GR (SA) NEW Telfast 120mg 1x10 Mal Profenid Suppository for ASKES Telfast 120mg 2 tab AUST - USA Ramipril 10mg PH Telfast 120mg 2X10 (HK) Ramipril 2.5mg PH Telfast 120mg 30tab NZ-UK Ramipril 5 mg 100'S Phililpines Telfast 120mg 30tab USA-UK Ramipril 5mg PH Telfast 120mg 5tab AU (NZ) Recansa 10,0 mg (3x10') Telfast 120mg 5TAB AUST - USA Recansa 20,0 mg (3x10') Telfast 120mg 5tab NZ-UK Rovamycine 1.5 MIU Tab (10x10') Telfast 120mg 5x10 (OM)-SG Rovamycine 3 MIU (MRCSI) Telfast 180 2x10 (HK) Roxithromycin x 10' (PH) Telfast 180 mg 1 x 10 ' HK Roxithromycin x 10' (PH) Telfast 180 mg 1 x 10 ' Thailand Rulid 150 mg 3 x 10 Telfast 180 mg 5 x 10 ' HK Rulid 300 mg 5 x 10 (PH) Telfast 180 mg 5 x 10 ' MAL

15 Telfast 180 mg 5 x 10 ' PH Telfast 60 MG 10 TAB NZ-USA Telfast 180 mg 5 x 10 ' Thailand Telfast 60 mg 10 Tablets Telfast 180 mg Philipine Telfast 60 mg 1x10' TH OM Telfast 180 mg (3x10') AUST-SA Telfast 60 mg 5x10 TH-OM Telfast 180 mg 10 Tablets Telfast 60 mg New Zealand Telfast 180 mg 10 Tablets Telfast 60mg (2 x 10') AUST (SA) Telfast 180 mg 10 tabs Telfast 60mg (2x10') AUST - USA Telfast 180 mg 1x10' (OM)-SG Telfast 60mg 10tab GROCERY-UK Telfast 180 mg 1x10' TH OM Telfast 60mg 10tab NZ-UK Telfast 180 mg 2 Tablets Telfast 60mg 10TABS GROCERY Telfast 180 mg 30 Tablets Telfast 60mg 20tab AUST-USA Telfast 180 mg 30 Tablets Telfast 60mg 20tab NZ-UK Telfast 180 mg 30 tabs Telfast 60mg 20tabs Telfast 180 mg 50 Tablets Telfast BD 60 mg 1 x 10 ' VN Telfast 180 mg 5x10' TH OM Telfast BD 60 mg 10 ' VN (SA) OTC Telfast 180 mg 5x10'PH (SA) Telfast BD 60MG 10'VN OTC-1 Telfast 180 mg 60 Tablets Telfast D 1 x 10 ' HK Telfast 180 mg 70 Tablets Telfast D 1 x 10 ' SG Telfast 180mg (1x10') AU SA Telfast D 5 x 10 ' HK Telfast 180mg (3x10') AU SA Telfast D 5 x 10 ' MAL Telfast 180mg (7x10') AU SA Telfast D 5 x 10 ' SG Telfast 180mg 10tab AU-USA Telfast D (Reclasification)-SG Telfast 180mg 10tab NZ - UK Telfast D 2X10 (HK) Telfast 180mg 10tab NZ-USA Telfast D tabs HPM Telfast 180mg 10tabs Telfast HD 180 mg 1 x 10 ' Telfast 180mg 2 tab AU-USA Telfast HD 180 mg 10 ' VN (SA) OTC Telfast 180mg 2tab AU-SA Telfast HD 180 mg 1x10' Telfast 180mg 2tab sample pack NZ- Telfast HD 180mg HPM UK Telfast 180mg 30tab AU-USA Telfast OD 120 mg 1 Telfast 180mg 30tab NZ-UK Telfast OD 120 mg 10 x 10 ' OM Telfast 180mg 30tab NZ-USA Telfast OD 120 mg 10x10' Telfast 180mg 50tab AU-USA Telfast OD 120 mg 3x10' KH Telfast 180mg 5x10 SG Telfast OD 120MG 3X10'KH Telfast 180mg 70TAB AUST - USA Telfast Plus 10 x 10 ' Telfast 180mg 70tabs TETRAct-HIB Telfast 30 mg 20 Tablets Tetraxim Telfast 30 mg 20 TABS AUST-USA Toplexil Syrup 120 ml Telfast 30 mg 5x10 ID Toplexil syrup 60mL Telfast 30mg (2X10') AUST - SA Trental 400 mg FCT 10 x 10 TH Telfast 60 mg 10 ' VN Trental 400 mg (SA) Telfast 60 mg 1 x 10 ' TH Trental TH 400 mg (SA)

16 Telfast 60 mg 5 x 10 ' TH Triatec 2.5 mg 10 x 10 PH Triatec 2.5 mg 10 x 10 TH Triatec 2.5 mg 6 x 10' (SA) Triatec 5 mg 10 x 10 PH Triatec 5 mg 6 x 10 VN Triatec 5 mg 6 x 10' (SA) Triatec 5MG (3x10') VN Tripacel Tritace 10 mg Tritace 10 mg 3 x 10 TH Tritace 2.5 mg Tritace 5 mg Tritace 5 mg 3 x 10 TH Typhim Vi Urbason Tablet Urbason Tablet Trental 400mg 10x10' TH (SA) Taxotere 20mg/1ml Taxotere 20mg/1ml ASKES Frisium Tablet (SA) Sofra-tulle Avomine 25 mg x 30 tablets Avomine 25 mg x 10 tablets Modalim 100 mg tablet Triatec 10 mg 30' PH