DAFTAR ISI

Halaman
LEMBAR PENGESAHAN............................................................................. i
KATA PENGANTAR...................................................................................... ii
DAFTAR ISI.................................................................................................... iv
DAFTAR LAMPIRAN................................................................................... vii

DAFTAR GAMBAR....................................................................................... viii

DAFTAR TABEL............................................................................................ ix
BAB I PENDAHULUAN............................................................................. 1

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

1.2 Tujuan Kegiatan............................................................................ 3

1.2.1 Tujuan Umum..................................................................... 3

1.2.2 Tujuan Khusus.................................................................... 4

1.3 Ruang Lingkup............................................................................. 4

1.4 Pelaksanaan Kegiatan................................................................... 4

BAB II TINJAUAN UMUM......................................................................... 5

2.1 Definisi Industri........................................................................... 5

2.2 Persyaratan Usaha Industri Farmasi............................................ 5

2.3 Cara Pembuaatan Obat yang Baik (CPOB)................................. 7

2.3.1 Manajemen Mutu............................................................. 7

2.3.2 Personalia......................................................................... 7

2.3.3 Bangunan dan Fasilitas..................................................... 8

2.3.4 Peralatan.......................................................................... 8

2.3.5 Sanitasi dan Hagiene....................................................... 8

2.3.6 Produksi........................................................................... 9

2.3.7 Pengawasan Mutu............................................................ 9

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 2.3.8 Inspeksi Diri dan Audit Mutu.......................................... 9

2.3.9 Penanganan Keluhan Terhadap Produk, Pemarikan

Kembali dan Produk Kembali........................................... 10

2.3.10 Dokumentasi..................................................................... 10

2.3.11 Pembuatan dan Analisis Berdasarkan Kontrak Prinsip.... 11

2.3.12 Kualifikasi dan Validasi................................................... 11

BAB III TINJAUAN KHUSUS..................................................................... 12

3.1 Sejarah Berdirinya PT. Ferron Par Pharmaceuticals.................. 12

3.2 Visi, Misi, Logo dan Tujuan Perusahaan................................... 13

3.2.1 Visi.................................................................................... 13

3.2.2 Misi................................................................................... 13

3.2.3 Logo.................................................................................. 14

3.2.4 Tujuan............................................................................... 14

3.3 Lokasi dan Letak Geografis....................................................... 15

3.4 Struktur Organisasi..................................................................... 15

3.5 Produk dan Sertifikasi yang Diperoleh...................................... 18

3.6 Saran Produksi Pabrik................................................................ 19

3.6.1 Bangunan.......................................................................... 19

3.6.2 Pembagian Daerah............................................................ 22

3.6.3 Saran Produksi.................................................................. 24

3.6.4 Sarana Penunjang Produksi.............................................. 28

BAB IV PEMBAHASAN.............................................................................. 30
BAB V PENUTUP........................................................................................ 35

5.1 Kesimpulan.................................................................................. 35

5.2 Saran............................................................................................ 36
DAFTAR PUSTAKA....................................................................................... 37
LAMPIRAN..................................................................................................... 38

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 DAFTAR LAMPIRAN

Lampiran Halaman

1.Jenis-jenis Produk yang Dihasilkan PT. Ferron Par

Pharmaceuticals...................................................................... 38

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 DAFTAR GAMBAR

Gambar Halaman

2. Logo PT. Ferron Par Pharmaceuticals.......................................... 14

3. Sertifikat CPOB yang diperoleh PT. Ferron Par Pharmaceutical 19

4. Produk Cardiovascular Metabolic.............................................. 38

5. Produk Kemoterapi.................................................................... 39

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 6. Produk Dermatological Cosmetik............................................... 39

7. Produk Gastri intestinal.............................................................. 39

8. Produk Neuromuscular System................................................... 40

9. Produk Opthalmological............................................................ 40

10. Produk Lainnya......................................................................... 40

DAFTAR TABEL

Tabel Halaman

1. Setifikat CPOB yang Diperoleh PT. Ferron Par Pharmaceucticals.. 29

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