KATA PENGANTAR

Puji dan syukur kepada Allah SWT atas Rahmat dan Karunia-Nya, sehingga

penulis dapat menyelesaikan laporan Praktek Kerja Profesi Apoteker (PKPA) di

PT Taisho Pharmaceutical Indonesia Tbk. Praktek Kerja Profesi Apoteker yang

dilaksanakan pada tanggal 3 Februari – 28 Maret 2014 ini disusun sebagai salah

satu persyaratan pada Program Studi Profesi Apoteker di Fakultas Farmasi,

Universitas Padjadjaran.

Penulis menyampaikan terima kasih kepada semua pihak yang telah

memberikan bantuan, dukungan, petunjuk, bimbingan, saran serta berbagai

fasilitas dan kemudahan bagi penulis, yaitu:

1. Dr. Ahmad Muhtadi, M.S., Apt., selaku Dekan Fakultas Farmasi Universitas

Padjadjaran.

2. Drs. Sohadi Warya, M.S., Apt., selaku Ketua Program Studi Profesi Apoteker

beserta seluruh staf pengajar Fakultas Farmasi Universitas Padjadjaran.

3. M. Sumarno, selaku Technical Operation Director PT Taisho Pharmaceutical

Indonesia Tbk.

4. Ika Kartikaningrum, selaku koordinator pembimbing dari Lean Continous

Improvement and Training Manager PT Taisho Pharmaceutical Indonesia

Tbk.

5. Panji Dewa Jayeng Raga, S. Si., Apt., selaku pembimbing dari Value Stream

Tempra Manager PT Taisho Pharmaceutical Indonesia Tbk..

6. Dr. Moelyono M. W., M.Si, Apt., selaku pembimbing dari Fakultas Farmasi,

Universitas Padjadjaran.

7. Seluruh staf dan karyawan PT Taisho Pharmaceutical Indonesia Tbk.

8. Keluarga tercinta, rekan-rekan Program Profesi Apoteker tahun ajar 2013 -

2014, dan semua pihak yang tidak dapat disebutkan satu-persatu, yang telah

memberikan doa dan dukungannya dalam menyelesaikan praktik kerja profesi

ini. Pihak-pihak lain yang tidak dapat disebutkan satu persatu yang telah

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memberikan bantuan baik secara langsung maupun tidak langsung kepada

penulis.

Penulis berharap semoga pengetahuan dan pengalaman yang diperoleh

selama menjalani PKPA dapat memberikan manfaat bagi semua pihak. Penulis

menyadari bahwa laporan ini masih jauh dari kesempurnaan untuk itu saran dan

kritik yang membangun dari pembaca sangat diharapkan untuk penyempurnaan

laporan ini.

Jatinangor, Maret 2014

Penulis

iv

DAFTAR ISI

Halaman

LEMBAR PENGESAHAN.......................................................................... ii

KATA PENGANTAR.................................................................................. iii

DAFTAR ISI................................................................................................. v

DAFTAR TABEL......................................................................................... viii

DAFTAR GAMBAR.................................................................................... ix

DAFTAR LAMPIRAN................................................................................ x

BAB I PENDAHULUAN........................................................................... 1

1.1 Latar Belakang Praktek Kerja Profesi Apoteker.................... 1

1.2 Tujuan Praktek Kerja Profesi Apoteker.................................. 2

1.3 Tinjauan Tentang Tempat Praktek Kerja Profesi Apoteker.... 2

BAB II PERANAN, FUNGSI DAN TUGAS APOTEKER DI

INDUSTRI FARMASI

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4

2.1 Peran Apoteker dalam Produksi............................................. 5

2.2 Peran Apoteker dalam Pemastian Mutu.................................. 6

2.3 Peran Apoteker dalam Pengawasan Mutu.............................. 9

2.4 Peran Apoteker dalam Technical Service............................... 10

BAB III KEGIATAN DAN HASIL PRAKTEK KERJA PROFESI

APOTEKER

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v

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12

3.1 Tinjauan Khusus PT Taisho Pharmaceutical Indonesia Tbk. . 12

3.2 Purchasing Department.......................................................... 13

3.3 Warehouse Department.......................................................... 14

3.4 Quality Operational Department............................................ 16

3.4.1 Quality Control (QC) Department........................... 17

..................................................................................

3.4.2 Quality Assurance (QA) Department....................... 20

3.4.3 Training Department................................................ 20

3.5 Value Stream Counterpain...................................................... 21

3.6 Value Stream Tempra............................................................. 23

3.7 Value Stream Diamond........................................................... 25

3.8 Technical Service Departement.............................................. 27

3.8.1 Manufacturing Technology...................................... 27

3.8.2 Packaging Development........................................... 29

3.8.3 Validation................................................................. 29

3.9 Maintenance, Engineering and Continuous Innovation,

EHS, Project (ME &CEP) Departement................................ 33

3.9.1 Maintenance and Engineering (ME)

..................................................................................

..................................................................................

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33

3.9.2 Occupancy................................................................ 33

3.9.3 Utility........................................................................ 34

3.9.4 Continuous Innovation (CI)...................................... 34

3.9.5 Project...................................................................... 35

3.9.6 Environment, Health and Safety Comittee Department 35

3.10 Penerapan CPOB di PT Taisho Pharmaceutical Indonesia

Tbk.

vi

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38

3.10.1 Manajemen Mutu

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38

3.10.2 Personalia

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38

3.10.3 Bangunan dan Fasilitas

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39

3.10.4 Peralatan

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42

3.10.5 Sanitasi dan Hygiene

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43

3.10.6 Produksi

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vii

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45

3.10.7 Pengawasan Mutu

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49

3.10.8 Inspeksi Diri dan Audit Mutu

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52

3.10.8.1 Inspeksi Diri

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52

3.10.8.2 Audit Mutu

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53

3.10.9 Penanganan Keluhan Terhadap Produk, Penarikan

Kembali Produk dan Produk Kembalian.................. 53

3.10.10 Dokumentasi

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55

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3.10.11 Pembuatan dan Analisis berdasarkan Kontrak

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56

3.10.12 Kualifikasi dan Validasi

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57

3.11 Tugas Khusus: Review Dokumen Halal

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59

3.11.1 Latar Belakang.......................................................... 59

3.11.2 Objektif..................................................................... 61

3.11.3 Waktu Pelaksanaan................................................... 61

3.11.4 Identifikasi Masalah................................................. 61

3.11.5 Pengumpulan Data.................................................... 62

3.11.6 Analisis Data............................................................. 63

3.11.7 Result........................................................................ 65

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3.11.8 Saran......................................................................... 72

4 BAB IV SIMPULAN DAN SARAN............................................................ 73

4.1 Simpulan................................................................................. 73

4.2 Saran....................................................................................... 74

5 DAFTAR PUSTAKA................................................................................... 75

6 LAMPIRAN.................................................................................................. 76

ix

DAFTAR TABEL

Halaman

3.1 Waktu Pelaksanaan .............................................................................. 61

x

DAFTAR GAMBAR

Halaman3.1. Struktur Organisasi Value Stream Counterpain....................................... 21

3.2. Struktur Organisasi Value Stream Tempra.............................................. 23

3.3. Struktur Organisasi Value Stream Diamond............................................ 25

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3.4.

DAFTAR LAMPIRAN

Halaman

A. STRUKTUR ORGANISASI TECHNICAL OPERATION PT TAISHO PHARMACEUTICAL INDONESIA TBK.............................

B. STRUKTUR ORGANISASI QUALITY OPERATION DEPARTMENT......................................................................................

C. STRUKTUR ORGANISASI TECHNICAL SERVICE DEPARTMENT...................................................................................... 78

D. STRUKTUR ORGANISASI MAINTENANCE, ENGINEERING & CONTINOUS INOVATION, ENVIRONMENT HEALTH AND SAFETY, PROJECT (ME & CEP) DEPARTMENT............................. 79

E. PRETREATMENT PENGOLAHAN PURIFIED WATER................... 80

F. FLOW PROCESS REVERSE OSMOSIS (RO) SYSTEM.................... 81

G. DECISION TREE INDENTIFIKASI TITIK KRITIS KEHARAMAN PENYIMPANAN DAN LINI PRODUKSI............................................ 82

H. DECISION TREE PROSEDUR PENETAPAN STATUS BAHAN...... 83

I. DECISION TREE IDENTIFIKASI TITIK KRITIS KEHARAMAN DISTRIBUSI........................................................................................... 84

J. PENETAPAN TITIK KRITIS KEHARAMAN PARASETAMOL....... 85

K. PENETAPAN TITIK KRITIS KEHARAMAN KELACID NF............. 86

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xii

L. ML-RM-018.05....................................................................................... 87

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