Lampiran 1. Bagan struktur organisasi PT. Prafa. Plant Manager Ariyono W Ardi Secretary
GMP Compliance
Ana Maria Ulfah Continous Improvement
Material Management Manager Yun Lisnawati
PGA Manager Intan Nurmaya
Production Manager Budi Handoyo
Quality Assurance Manager Emi Pudjiastuti
Dede Muhardi
Personal Affairs Supervisor (Vacant)
Solid NBL Supervisor Endang Pudjiati
QC Lab. Supervisor Ahmad Rodjai Hassan
Dispensary Supervisor
Utility Supervisor
General Affairs
Micro Lab. Supervisor
Vacant (to be hired)
Vacant (to be hired)
Supervisor (Vacant)
Sterile NBL Supervisor Budi Utomo
Warehouse Supervisor
Electrical Supervisor
HSE Coordinator
Sukarno
Vacant
Firmansyah
PPIC Supervisor Ida Suhardiah
Technical Service Manager Santoso Maintenance Supervisor
Beta Cepha Supervisor Arif Suryadi
Melly Kamilia Dini
QA Supervisor Farida
Central Packaging
Calibration & Validation
Supervisor
Supervisor
Nasihin
Antonious Raino Dymita
P&G Supervisor Ademulyana
P&G Supervisor Vacant
Universitas Sumatera Utara
Lampiran 2. Denah Bangunan PT. Prafa
Security Guard FG Warehouse
Central Laundry
Toll Jkt-Bgr
Technical Services Flammable Warehouse
Non-BL Building RM/PM Warehouse Betalactam Building
Waste Water Treatment Plant
Universitas Sumatera Utara
Lampiran 3. Struktur Organisasi Material Management Department
MM. Manager
PPIC Spv
PRAFA Mtrls W/H
PPIC
Dispensary Section head ERIC Opr
Warehouse Spv
Weigher
ERIC Opr
W/H-man
P&G Mtrls W/H
FG W/H
W/H-man
Forklift Opr
W/H-man
Planner P&G product
Planner Prafa Product
PPIC Officer
Universitas Sumatera Utara
Lampiran 4. Alur Aktivitas Material Management Department
Yes
No
Universitas Sumatera Utara
Lampiran 5. Struktur Organisasi Production Department
Production Manager Budi Handoyo
Solid NBL Spv Endang P
Sterile NBL Spv Budi Utomo Granulation (SH) Tableting (SH)
Coating& 1stPacking (SH)
Sterile NBL (SH)
BL Prod Spv Mahfud
Packaging Spv Nasihin Solid (SH)
Solid BL (SH)
Sterile (SH)
Solid NBL (SH)
P&G Prod Spv Ade Mulyana F44 Shift 1 (SH) F44 Shift 2 (SH) F44 Shift 3 (SH) VR & Inh (SH)
Universitas Sumatera Utara
Lampiran 6. Alur Proses Produksi di PT. Prafa
MO & MRD
Produksi
MRD
PPIC
Packaging Material WH Raw Material WH
Gudang Obat Jadi
MI PHP (Pengiriman Hasil Produksi) Proses Produksi
IPC
Produk Jadi
IPC Produk Ruahan
Universitas Sumatera Utara
Lampiran 7. Alur Proses Produksi Sediaan Solid dengan Wet Granulation
Zat aktif + filler Pramixing Larutan binder/warna
Spraying
Dengan Fluid Bed Granulator
Drying IPC Dry granulatesieving Lubricant + desintegrant
Final mixing IPC Tabletting/filling capsule IPC Primary packing
Coating/Polishing IPC
IPC Central Packaging
Universitas Sumatera Utara
Lampiran 8. Alur Proses Produksi Sediaan Solid dengan Dry Granulation
Zat aktif + filler + lubricant
Mixing IPC Compacting/slugging IPC
Sieving
Final mixing IPC Tabletting IPC
Coating/Polishing IPC
Primary packing IPC Central Packaging
Universitas Sumatera Utara
Lampiran 9. Alur Proses Produksi Sediaan Steril Primary PM Raw Material
Washing
IPC Sterilization
Mixing
IPC
IPC Filling
Seal Capping
Final Sterilization
Labeling
IPC Packaging
Universitas Sumatera Utara
Lampiran 10. Alur Proses Produksi Sirup Kering
IPC
Primary PM Raw Material Washing
IPC Mixing
Pengeringan di o oven 170 C, 2 jam
IPC
Fillling Low Humidity Seal Capping
IPC Labelling IPC Packaging
Universitas Sumatera Utara
Lampiran 11. Alur Proses Produksi Injeksi Kering Primary PM
Washing
Sterilization
IPC
Raw Material
IPC Filling
Low Humidity Seal Capping
Labeling
IPC Packaging
Universitas Sumatera Utara
Lampiran 12. Alur Proses Pengemasan Sentral
Produksi (pengemasan primer)
MO
Pengemasan Sentral
MRD
MR
Gudang Obat Jadi
PHP MRD
MI
Gudang Obat Kemas
Universitas Sumatera Utara
Lampiran 13. Struktur Organisasi QA/QC Department
QA Manager Emi Pujiastuti
Chem Lab Spv Ahmad Rojai RM QA
RM Inspector
Analyst
Micro Lab Spv Melly KD Analyst
Lab Tech
IPC Spv Farida
Validation Spv A. Raino D IPC
IPC Inspector
Lab Tech
Calibration Technician
QA Spv (Vacant)
DCC
Validation Pharmacist
GMP Coordinator
Lab Tech
Universitas Sumatera Utara
Lampiran 14. Diagram Alir Proses Pengolahan Limbah Cair Betalaktam
Limbah : ‐ ‐
Substandar produk yang mengandung antibiotik Bilasan alat & buangan proses
Dikumpulkan dalam collecting tank & cek pH
NaOH
Ditambah NaOH sampai pH 10-11 dan diaduk menggunakan recirculating pump selama 120 menit
HCl
Netralisasi dengan HCl sampai pH 7 dan diaduk selama 30 menit
Dibuang / dialirkan ke dalam bak ekualisasi
Universitas Sumatera Utara
Lampiran 15. Diagram Alir Proses Pengolahan Limbah Cair Non Betalaktam
Limbah Cair
Bak Ekualisasi
Bak Reaksi NaOH
HCl Bak Separasi
Bak Aerasi I PAC Bak Filtrasi I
Bak Aerasi II SGB 14 Bak Filtrasi II
Bak Settle NaOCl Bak Desinfeksi
Effluent
Universitas Sumatera Utara
Lampiran 16. Struktur Organisasi Technical Services Department TS Manager Santoso ADM/Data/Draftsman Wahyu Amperawati
Electrical Supervisor Vacant
Maintance Supervisor Ade Hidayat
Maintance Section Head Abdul Majid
Electrical Section Head Adi Kurnianto
Utility Section Head Vacant
Electrician Udin Unan
Senior Mechanic Sumarna Senior Mechanic Kartiyo Mechanic Hatoyo Workshop Mechanic Lardi
Utility Mechanic Mukhalip
DIW Treat Operator Indraman
Utility Mechanic Vacant
DIW Treat Operator Wakijo
Utility Piping Mechanic Salmikin
DIW Treat Operator Supriyanto
Electrician Suherman
Universitas Sumatera Utara
Lampiran 17. Purified Water System PT. Prafa Deep well water
Water Chlorine tank
Multimedia filter
Carbon filter
Filter 5 μm
Cation Bed
Anion Bed
Mix Bed
Filter 1 μm
Filter 0.45 μm
UV Light
Filter 0.2 μm
PHE suhu 90oC
Purified Water storage tank
Universitas Sumatera Utara
Lampiran 18. Diagram Alir Pembuatan WFI Purified water
Tampung dalam tanki double jacket
Side tank
Finn aqua destilator Column I Column II Column III Column IV Column V
: 1390C : 1300C : 1230C : 1180C : 1140C
Storage tank dilengkapi heater
Disirkulasi
Universitas Sumatera Utara
Lampiran 19. Struktur Organisasi Personnel and General Affairs (PGA) Department
PGA Manager
Pay Master
Adm
Health and Safety Environment (HSE)
GA Affairs Spv
Personnel Affairs Spv
Receptionist
Driver
Laundry
House Keeping
Universitas Sumatera Utara
Lampiran 20. Struktur Organisasi Product Development Department (PDD)
Manager PDD
Liquid Supervisor
Solid Supervisor
Teknisi
Asisten Apoteker
Parentral Supervisor
Operator
Universitas Sumatera Utara
Lampiran 21. Alur Pengembangan Produk Baru Marketing
PDRF
PDD
HRA
Studi literatur Internet, buku standar, produk inovator dan kompetitor Trial skala laboratorium Minimal 2 formulasi yang sesuai
Pilot scale Sampel pilot scale untuk persetujuan produk
Validasi proses pilot scale, pengujian QA/QC, pengujian stabilitas
Data formula produk, spesifikasi, manufacturing procedure, validasi proses pilot scale, dan uji stabilitas
Registrasi
No. Registrasi
Keterangan: PDRF : Product Development Request Form PDD : Product and Development Department HRA : Health Regullatory Affair
Universitas Sumatera Utara
