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DAFTAR ISI

KATA PENGANTAR...................................................................................... ii

DAFTAR ISI.................................................................................................... iii

BAB I PENDAHULUAN

1.1 Latar Belakang................................................................................... 1

1.2 Tujuan Penelitian............................................................................... 3

BAB II TINJAUAN PUSTAKA

2.1. Industri Farmasi................................................................................ 3


2.2 Cara Pembuatan Obat Yang Baik(CPOB).......................................... 4
2.2.1 Sistem Mutu Industri Farmasi................................................... 4
2.2.2 Personalia.................................................................................. 6
2.2.3 Bangunan dan Fasilitas............................................................. 8
2.2.4 Peralatan.................................................................................... 10
2.2.5 Produksi.................................................................................... 11
2.2.6 Cara Penyimpanan Dan Pengiriman Obat yang baik................ 14
2.2.7 Pengawasan Mutu..................................................................... 17
2.2.8 Inspeksi Diri.............................................................................. 19
2.2.9 Keluhan dan Penarikan Produk................................................. 20
2.2.10 Dokumentas............................................................................ 20
2.2.11 Kegiatan Alih Daya................................................................. 21
2.2.12 Kualifikasi Dan Validasi......................................................... 22

BAB III TUGAS BAHASAN LITERATUR INDUSTRI

3.1 Teori................................................................................................... 25
3.2 Prosedur............................................................................................. 34
3.3 Pembahasan........................................................................................ 37
3.4 Kesimpulan........................................................................................ 45

DAFTAR PUSTAKA........................................................................................46

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