Struktur Organisasi PT. PRAFA per 1 Juni 2010

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Lampiran 1. Struktur Organisasi PT. PRAFA per 1 Juni 2010

Plant Manager Secretary PGA Manager TS Manager Logistic Manager Production Manager Quality Operation Manager PPC Spv RM&PM Warehouse Spv FG Warehouse Spv Maintenance Spv Utility Spv Electrical Spv Civil Work Spv Personnel Affairs Spv General Affairs Spv HSE Coordinator Solid NBL Senior Spv Sterile NBL Spv BL & CPL Spv Central Packaging Spv P&G Spv QC Senior Spv QC Lab Spv Micro Lab Spv Inspection Spv QA Senior Spv System Compliance Spv Product Integrity Spv Validation & Calibration

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64 Lampiran 1. (lanjutan)

FG = Finished Goods

HSE = Health and Safety Environment Micro = Microbiology

NBL = Non Betalaktam

PGA = Personnel and General Affairs PM = Packaging Material

PPC = Production Planning Control QA = Quality Assurance

QC = Quality Control RM = Raw Material Spv = Supervisor

TS = Technical Services

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Lampiran 2. Alur Barang yang Dikelola Departemen Logistik di PT. PRAFA secara Umum

Keterangan :

BPR = Batch Production Record CoA = Certificate of Analysis

PPC

Approved Supplier

Distributor Departemen Logistik

Gudang Bahan Baku &

Bahan Kemas Dispensary Gudang Obat Jadi Departemen QA/QC PO CoA Surat jalan QA rejected IML PRL/PRI IPC Departemen Produksi Divisi Produksi

yang lain Central Packaging QA released MI MO MRD MO MRD BPR QA released MI PHP repacking DO retur

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66 Lampiran 2. (lanjutan)

MRD= Material Requirement Document PHP = Pengiriman Hasil Produksi PO = Purchase Order

PPC = Production Planning Control PRI = Purchase Receipt Import PRL = Purchase Receipt Local

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Lampiran 3. Struktur Organisasi Departemen Produksi

Keterangan : VR = Vaporub Inh = Inhaler Production Manager VR & Inh Solid NBL Spv Packaging Spv BL Production Spv Sterile NBL Spv P&G Line Spv Granulation Tableting Coating& Primary Packaging Sterile NBL Solid Sterile Solid& Sterile BL Solid& Sterile NBL F44 Syrup Packaging

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Lampiran 4. Alur Proses Produksi secara Umum di PT. PRAFA

dokumen produksi (BPR &PDR) MO MRD MI PHP MI Keterangan :

PDRP = Packaging Direction Record Primary PDRS = Packaging Direction Record Secondary

Obat Jadi

Central Packaging

(PDRS) PPC

Produksi Gudang Bahan Baku

&

Gudang Bahan Kemas

Gudang Obat Jadi Proses Produksi (BPR) Produk Ruahan (PDRP)

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Lampiran 5. Alur Proses Produksi Sediaan Solid Dengan Metode Granulasi Basah

Keterangan :

FBD = Fluid Bed Dryer LOD = Loss of Drying

Bahan aktif + Pengisi Pramixing

Granulasi Basah + bahan Pengikat

Coating/Polishing pengeringan Pengayakan basah Final mixing Tableting/capsule filling Pengayakan kering Obat jadi Pengemasan Primer Pengemasan Sekunder Dengan FBD Bhn pelicin + penghancur + perasa (bila diperlukan)

IPC

IPC _IPC

IPC

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Lampiran 6. Alur Proses Produksi Sediaan Solid Dengan Metode Spraying

Bahan aktif + Pengisi Pramixing

Final mixing Pengayakan kering

Pengeringan Spraying

Larutan pengikat Dengan FBD

bhn Pelicin + Penghancur Coating/Polishing Pengemasan Primer Pengemasan Sekunder IPC IPC IPC IPC Obat jadi Dicek LOD Tableting/capsule filling

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Lampiran 7. Alur Proses Produksi Sediaan Solid Dengan Metode Granulasi Kering

Bahan aktif + Pengisi + Pelicin Mixing Slugging Pengayakan Final mixing Coating/Polishing Pengemasan primer Pengemasan sekunder IPC IPC IPC IPC IPC Obat jadi Tableting/capsule filling

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Lampiran 8. Alur Proses Produksi Sediaan Steril

Inspection

IPC : pemerian, pH, dan kadar zat aktif

IPC : keseragaman volume dan kebocoran Sealing

IPC : uji sterilisasi Kemasan Primer Washing Sterilization Filtration Filling Final Sterilization Labeling Packaging Raw Material Mixing

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Lampiran 9. Alur Proses Produksi Sediaan Solid Dengan Metode Cetak Langsung Penimbangan Mixing Tabletting Pengemasan primer Pengemasan sekunder IPC IPC IPC Obat jadi

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IPC Lampiran 10. Alur Proses Produksi Sirup Kering

Keterangan :

PM = Packaging Material

Primary PM Raw Material

Washing Weighing Mixing Pengeringan di oven 170oC, 2 jam Fillling Seal Capping Labelling Packaging Sealing Low Humidity IPC IPC IPC filling

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IPC Lampiran 11. Alur Proses Produksi Serbuk Injeksi Kering

Kemasan Primer Washing Sterilization Filling Sealing Labeling Packaging Bahan aktif Low Humidity

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76 Lampiran 12. Alur Proses Pengemasan Sentral

MO PHP MRD MRD MI

Produksi (pengemasan primer)

Pengemasan Sentral Gudang Obat Jadi

Gudang Bahan Kemas

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Lampiran 13. Struktur Organisasi Departemen QA/QC

Quality Operation Manager

QC Senior Spv

QC Lab Spv Micro Lab Spv Inspection Spv System compliance Spv Product integrity Spv Validation and Calibration Spv QA Senior Spv

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Lampiran 14 Struktur Organisasi Product Development Department

Manajer PDD Generic Product Development Supervisor Cosmeceutical Product Development Supervisor Natural Product Development Supervisor Researcher Junior Researcher Aid Junior Researcher Researcher Machine operator Clerk Assistent manager Researcher Researcher

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Lampiran 15. Alur Pengembangan Produk Baru oleh Product Development Department

Marketing PDD HRA

Keterangan :

HRA = Health Regulatory Affair

PDD = Product Development Department PDRF Studi literatur

Buku, internet, produk inovator dan kompetitor

Laboratory trial Minimal 2 formulasi yang optimal Pilot scale trial QA/QC test (stability) Registrasi Data formula produk, spesifikasi,

manufacturing procedure,

validasi proses pilot scale, dan uji stabilitas No. Registrasi Marketing Approval Commercial production batch

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Lampiran 16. Struktur Organisasi Departemen Technical Services

Keterangan :

DIW Treat = Deionized Water Treatment TS Manager ADM Electrical Supervisor Maintenance Supervisor Electrical Section Head Electrician Maintenance Section Head Utility Section Head Utility Mechanic Utility/piping Mechanic DIW Treat. Operator Senior Mechanic Mechanic Workshop Mechanic

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tidak Lampiran 17. Alur Pembuatan Purified Water di PT. PRAFA

Pengisian air sumur ke storage tank

Pengisian NaOCl 1,5-2 ppm START

Dialirkan ke Multimedia filter Dialirkan ke karbon filter

Dialirkan ke cartridge filter 5 µm Dialirkan ke kation bed

Dialirkan ke anion bed

Dialirkan ke mix bed Dialirkan ke cardridge filter 1 µm Dialirkan ke cardridge filter 0,5 µm

Dilakukan penyinaran UV

Dialirkan ke PHE (plate heat exchanger)

Dialirkan ke storage tank Pemeriksaan suhu 85-93o_C

Pemeriksaan suhu 85-93o_C

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Lampiran 18. Alur Pembuatan Water For Injection di PT. PRAFA

Pengisian Purified Water ke tanki double jacket

Pemeriksaan suhu START

didestilasi dengan Finn aqua destilator

Dikondensasi dengan kondensor

Dialirkan ke storage tank yang dilengkapi heater

Pemeriksaan suhu 80-90ºC Memenuhi persyaratan ya Disirkulasi STOP tidak

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Lampiran 19. Struktur Organisasi Departemen Personnel and General Affairs

Keterangan:

WWTP = Waste Water Treatment Process Manajer PGA

Personnel Affairs Supervisor

General Affairs Supervisor

Health & Safety Environment Coordinator Pay master Pers Adm Receptionist Driver Laundry Housekeeping WWTP

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Lampiran 20. Alur Proses Pretreatment Limbah Cair Betalaktam Dan Cephalosporin

Limbah :

- Substandar produk yang mengandung antibiotik - Bilasan alat & buangan proses

Dikumpulkan dalam collecting tank & cek pH

NaOH 40%

Ditambah NaOH sampai pH 10-11 & diaduk menggunakan recirculating pump selama 120 menit

Netralisasi dengan HCl sampai pH 7 & diaduk selama 30 menit

Dibuang / dialirkan ke dalam tangki ekualisasi (dialirkan lewat pipa utama aliran limbah)

HCl 15%

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Lampiran 21. Alur Proses Pengolahan Limbah Cair Non Betalaktam

Keterangan :

PAC = Poly Aluminium Chloride NaOH 40%

HCl 32% _{Bak Ekualisasi}

Bak Pereaksi Bak Separasi

Fish bone weir

Bak Aerasi II Bak Aerasi I Bak Filtrasi I Bak Filtrasi II Bak Settle PAC Kolam Effluent Masih dapat digunakan untuk :

- Pertamanan - Kolam ikan - Air pendingin mesin - Pemadam kebakaran