Laporan Praktek Kerja Profesi Farmasi Industri

Lampiran 1. Peta Akses PT Aventis Pharma

Universitas Sumatera Utara

Lampiran 2. Peta Lokasi PT Aventis Pharma

Universitas Sumatera Utara

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

Universitas Sumatera Utara

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

Universitas Sumatera Utara


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
Regulatory
Site Officer

QC Analyst

QC Support

QC Analyst

QC Support

Universitas Sumatera Utara

Lampiran 6. Contoh Label


Pada barcode akan terlampir “RELEASED”, “REJECTED”, “QUARANTINE”
dan “SAMPLE TAKEN” yang menandakan label pada SAP.

Universitas Sumatera Utara

Lampiran 7. Alur Pemeriksaan Bahan Baku

Universitas Sumatera Utara

Lampiran 8. Persyaratan Jumlah Bakteri, Total Koliform dan Koliform Tinja
pada Masing-masing Jenis Air
No

Jenis uji

Air sumur

Air PAM


Portable
water

Purified
water
100 kol/
ml

MiliQPlus
100 kol/
ml

1

Jumlah
bakteri

Tidak
ditetapkan


100 kol/
ml

100 kol/ ml

2

Total
koliform

< 10

0 kol/
100 ml

0 kol/ 100
ml

-


-

3

Koliform
tinja

-

-

0 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.

Universitas Sumatera Utara

Lampiran 9. Skema Purified Water Plant

Universitas Sumatera Utara


Lampiran 10. Alur Penanganan Limbah

142
Universitas Sumatera Utara

Lampiran 11. Skema Waste Water Treatment Plant
Office building,
security,
packaging,
warehouse,
kantin, dapur

Main Purpose
Building

Collecting pit 1

Collecting pit 2

Production,
Purified Water

Antibiotic waste

Collecting pit 3

Perforated bath stream
Equalization tank

Aeration tank
Sedimentation tank
Sludge

Water

Sludge tank

Clean water tank

Sludge drying bed

Dry sludge

River

Effluent/
water

+hipoklorit

Connect to
WWTP operator
room for
sampling
purposes

PPLI

143
Universitas Sumatera Utara

Lampiran 12. Denah Warehouse

Universitas Sumatera Utara

Lampiran 13. Daftar produk PT Aventis Pharma
Actonel 35mg
Amaryl 1 mg 3x10 VN (SA)
Amaryl 1 mg 5x10
Amaryl 2 mg 3x10 VN
Amaryl 2 mg 5x10
Amaryl 2 mg VN (3x10')
Amaryl 3 mg 5x10 (SA)
Amaryl 4 mg (3 x 10') (TH)
Amaryl 4 mg 3 x 10' SA
Amaryl 4 mg 3x10 VN
Amaryl 4mg 3x10 (TH)
Amaryl M 1 mg 3X10
Amaryl M 2 mg 3X10
Amlogrix 10mg
Amlogrix 5 mg
Atorwin 10 mg (3x10')
Atorwin 20 mg (3x10')
Avaxim 160U Adult
Avaxim 80U Adult
Avaxim 80U Pediatric
Avaxim Adult
Avil 45,3 mg 50 Tab (SA)
Avil 45.3 mg x 50 tablet
Avil tablet
Aziwin 250
Aziwin 500
Batrafen Cream 10 g
BGStar Starter Kit mg
BGStar Test Strips x50
Cardace 10 mg
Cardace 10 mg 30'S(TH)
Cardace 2,5 mg 6x10'(askes)-1
Cardace 2.5mg TH
Cardace 5 mg
Cardace 5 mg 30 TH
Cardace 5 mg 6x10'(askes)-1
Coaprovel 300 mg/12,5 mg
Co-Irvebal 150 2X14
Co-Irvebal 300 2X14
Cordarone (Sanofi)
Daonil ( PH ) ( 10x10' )

Daonil 5 mg tab TH 10 x 10'
Daonil 5 mg tablet 10 x 10
Daonil 5 mg tablet MAL 10 x 10
Dermatop Cream 15G (SA)
Dermatop Cream 5G (SA)
Esperson Cream 15G
Esperson WO 5G (SA) - NEW
Favirab
Fexotabs 120 mg 50 TAB Aust-USA
Fexotabs 120mg 30TAB AUST - USA
Fexotabs 180 mg 10 tabs AUST-USA
Fexotabs 180 mg 50 Tablets (AU-UK)
Fexotabs 180mg 10tab Aust-UK
Fexotabs 180mg 30TAB AUST - UK
Fexotabs 180mg 30TAB AUST - USA
Fexotabs 180mg 50TAB AUST - UK
Fexotabs 180mg 50TAB AUST - USA
Fexotabs 60mg 20TAB AUST - USA
Flagyl 0.5 gr Suppository-OM
Flagyl 1 gr Suppository-OM
Flagyl Forte 500 mg 1' Physician
Flagyl Forte 500 mg tablet 10 x 10
Flagyl Forte 500 mg tablet PH
Flagyl O.S 60 ml
Flagyl OS 60 ml
Flagyl OS 60 ml Philipines
Flagystatin Ovule OM
Flagystatin Ovule SG
Flagystatin Ovule Philipine
Fludara tablet
Fludara injection
Frisium Tablet
Glibenclamide 3 x 10 (PH)
Grocery Pack Of Telfast 120 mg AU
Grocery Pack Of Telfast 60 mg Au
Imogam Rabies
Imovax Polio
Insulin Human Comb 25
Insuman Basal 100UI
Insuman Basal 100UI for ASKES
Insuman Human Generic

Universitas Sumatera Utara

Insuman Rapid
Insuman Rapid Generic
Irvebal 150 2X14
Irvebal 300 mg
Jevtana 60 mg
Lancets x 50 33G
Lasix Tablet
Loprox Nail 1.5 G
Lovenox 2000 anti-Xa IU/0.2 ml
Lovenox 4000 UI - NEW
Lovenox 4000 UI - NEW (ASKES)
Lovenox 6000 anti-Xa IU/0.6 ml
Lovenox 6000 UI - NEW (ASKES)
Metronidazole
Novalgin 500 mg tablet 10 x 10 (SA)
Novalgin 500mg 50x10 (SA)
Novalgin Drops 10 ml New
Novalgin Syrup 60 ml
Orudis E-100 10x10 (PH)
Orudis E-100 tablet
Pediacel 0.5 ml
Platogrix (2x14)
Plavix
Pneumo 23
Proctosedyl
Proctosedyl Suppo (MAL)
Profenid 100 mg Supp (SA)
profenid CR 200 Caps (SA)
Profenid E-100 tablet 10 x 10' (SA)
Profenid Gel 30 GR (SA) NEW
Profenid Suppository for ASKES
Ramipril 10mg PH
Ramipril 2.5mg PH
Ramipril 5 mg 100'S Phililpines
Ramipril 5mg PH
Recansa 10,0 mg (3x10')
Recansa 20,0 mg (3x10')
Rovamycine 1.5 MIU Tab (10x10')
Rovamycine 3 MIU (MRCSI)
Roxithromycin 150 3 x 10' (PH)
Roxithromycin 300 3 x 10' (PH)
Rulid 150 mg 3 x 10
Rulid 300 mg 5 x 10 (PH)

Solosa 1 mg 5 x 10
Solosa 2 mg 12 x 10(TH)
Solosa 2 mg 5 x 10
Solosa 3 mg 12 x 10 (TH)
Solosa 3 mg 5 x 10
Solosa 4 mg 3 x 10
Stilnox 10 mg tablet 2 x 10
Synvisc
Synvisc One
Taxotere 20mg
Taxotere 80mg
Telfast 120 mg 1 x 10 ' HK
Telfast 120 mg 5 x 10 ' HK
Telfast 120 mg 5 x 10 ' PH
Telfast 120 mg (2 tab) AUST (SA)
Telfast 120 mg (5 x 10') AUST (SA)
Telfast 120 mg 10 Tablets
Telfast 120 mg 30 Tablets
Telfast 120 mg 30 Tablets
Telfast 120 mg 5 Tablets
Telfast 120 mg Grocery
Telfast 120 mg NZ-UK
Telfast 120 mg Phil
Telfast 120mg (1x10') AUST - SA
Telfast 120mg (1x10') AUST - SA
Telfast 120mg (1x10) SG
Telfast 120mg (3x10') AUST - SA
Telfast 120mg 10TAB AUST - USA
Telfast 120mg 10tab NZ-UK
Telfast 120mg 1x10 Mal
Telfast 120mg 2 tab AUST - USA
Telfast 120mg 2X10 (HK)
Telfast 120mg 30tab NZ-UK
Telfast 120mg 30tab USA-UK
Telfast 120mg 5tab AU (NZ)
Telfast 120mg 5TAB AUST - USA
Telfast 120mg 5tab NZ-UK
Telfast 120mg 5x10 (OM)-SG
Telfast 180 2x10 (HK)
Telfast 180 mg 1 x 10 ' HK
Telfast 180 mg 1 x 10 ' Thailand
Telfast 180 mg 5 x 10 ' HK
Telfast 180 mg 5 x 10 ' MAL

Universitas Sumatera Utara

Telfast 180 mg 5 x 10 ' PH
Telfast 180 mg 5 x 10 ' Thailand
Telfast 180 mg Philipine
Telfast 180 mg (3x10') AUST-SA
Telfast 180 mg 10 Tablets
Telfast 180 mg 10 Tablets
Telfast 180 mg 10 tabs
Telfast 180 mg 1x10' (OM)-SG
Telfast 180 mg 1x10' TH OM
Telfast 180 mg 2 Tablets
Telfast 180 mg 30 Tablets
Telfast 180 mg 30 Tablets
Telfast 180 mg 30 tabs
Telfast 180 mg 50 Tablets
Telfast 180 mg 5x10' TH OM
Telfast 180 mg 5x10'PH (SA)
Telfast 180 mg 60 Tablets
Telfast 180 mg 70 Tablets
Telfast 180mg (1x10') AU–SA
Telfast 180mg (3x10') AU–SA
Telfast 180mg (7x10') AU–SA
Telfast 180mg 10tab AU-USA
Telfast 180mg 10tab NZ - UK
Telfast 180mg 10tab NZ-USA
Telfast 180mg 10tabs
Telfast 180mg 2 tab AU-USA
Telfast 180mg 2tab AU-SA
Telfast 180mg 2tab sample pack NZUK
Telfast 180mg 30tab AU-USA
Telfast 180mg 30tab NZ-UK
Telfast 180mg 30tab NZ-USA
Telfast 180mg 50tab AU-USA
Telfast 180mg 5x10 SG
Telfast 180mg 70TAB AUST - USA
Telfast 180mg 70tabs
Telfast 30 mg 20 Tablets
Telfast 30 mg 20 TABS AUST-USA
Telfast 30 mg 5x10 ID
Telfast 30mg (2X10') AUST - SA
Telfast 60 mg 10 ' VN
Telfast 60 mg 1 x 10 ' TH

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

Universitas Sumatera Utara

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

Universitas Sumatera Utara