Lampiran 1. Bagan struktur organisasi PT. Prafa. - USU Institutional ...

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


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


Lampiran 4. Alur Aktivitas Material Management Department

Yes

No


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)


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


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


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


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


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


Lampiran 11. Alur Proses Produksi Injeksi Kering Primary PM

Washing

Sterilization

IPC

Raw Material

IPC Filling

Low Humidity Seal Capping

Labeling

IPC Packaging


Lampiran 12. Alur Proses Pengemasan Sentral

Produksi (pengemasan primer)

MO

Pengemasan Sentral

MRD

MR

Gudang Obat Jadi

PHP MRD

MI

Gudang Obat Kemas


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


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


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


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


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


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


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


Lampiran 20. Struktur Organisasi Product Development Department (PDD)

Manager PDD

Liquid Supervisor

Solid Supervisor

Teknisi

Asisten Apoteker

Parentral Supervisor

Operator


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
