DAFTAR ISI

Halaman
HALAMAN JUDUL .....

LEMBAR PENGESAHAN ...............

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KATA PENGANTAR.............................

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DAFTAR ISI ...........................................

DAFTAR TABEL ..................................

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DAFTAR GAMBAR ......................................

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DAFTAR LAMPIRAN...................................................................................

BAB 1. PENDAHULUAN .

1.1 Latar Belakang ....................

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

1.3 Manfaat Praktek Kerja Profesi Apoteker........

BAB 2. TINJAUAN PUSTAKA ....

2.1 Industri Farmasi ....................................................................

2.2 Tugas dan Fungsi Industri Farmasi ..............................................

2.3 Perizinan Industri Farmasi ........................

2.4 Pencabutan Izin Usaha Industri Farmasi ...................

2.5 CPOB ................................

2.5.1 Manajemen Mutu..................................................................

2.5.2 Personalia .............................................................................

2.5.3 Bagunan dan Fasilitas ..........................................................

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2.5.4 Peralatan ..............................................................................

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2.5.5 Sanitasi dan Higine ..............................................................

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2.5.6 Produksi ..............................................................................

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2.5.7 Pengawasan Mutu................................................................

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2.5.8 Inspeksi Diri dan Audit Mutu ..............................................

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2.5.9 Penanganan Keluhan Terhadap Produk, Penarikan Produk

dan Produk Kembalian..........................................................

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2.5.10 Dokumentasi .......................................................................

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2.5.11 Pembuatan dan Analisis Berdasarkan

Kontrak...............................................................................

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2.5.12 Kualifikasi dan Validasi......................................................

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2.6 Peran, Fungsi dan Tugas Apoteker ...................

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2.6.1 Apoteker Penanggung Jawab produksi.................................

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2.6.2 Apoteker Penanggungjawab Pemastian Mutu .....................

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2.6.3 Apoteker Penanggungjawab Pengawasan Mutu...................

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BAB 3. TINJAUAN KHUSUS PT. GPL ......

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3.1 Sejarah PT. Galenium Pharmasia Laboratories

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3.2 Visi dan Misi Perusahaan ............................................

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3.3 Kebijakan Mutu Perusahaan..........................................................

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3.3.1 cGMP ......................................

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3.3.2 ISO 9001:2008 .......................

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3.3.3 5S/5R....................................................................................

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3.3.4 OHSAS 18001......................................................................

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3.4 Logo ..............................................

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3.5 Lokasi bagunan .....................................

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3.6 Struktur Organisasi .......................................

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3.7 Departemen Quality Assurance (QA) ...................

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3.8 Departemen Quality Control (QC) ..........................

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3.9 Departemen Health, Safety and Environment (HSE) ...

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3.9.1 Instalasi Pengolahan Air Limbah .........................

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3.10 Departemen Produksi Farma ...............

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3.11 Departemen Engineering ............................

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3.11.1 HVAC dan AHU ..................

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3.11.2 Purified Water System ...................

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3.12 Departemen Supply Chain (SC)..........

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3.12.1 PPIC (Production Planning Inventory Control).........

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3.12.2 Gudang ...........................................

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3.12.2 Sistem Dokumentasi ......................

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BAB 4. KEGIATAN PKPA DAN PEMBAHASAN ..

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4.1 Kegiatan yang dilakukan ..................................

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4.2 Tugas Khusus yang Dikerjakan Selama PKPA ..........

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4.2.1 Pembahasan Departemen Produksi Pharma dan Alur

Produksi Sediaan ....................

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4.2.2 Penerapan Budaya Kerja 5S di PT. GPL .....

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4.3 Pembahasan Departemen Produksi Pharma .................

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4.3.1 Proses Produksi ............................................

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BAB 5. KESIMPULAN DAN SARAN .....

5.1 Kesimpulan ..........

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5.2 Saran .........

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DAFTAR PUSTAKA .................................

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LAMPIRAN

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