DAFTAR ISI

Halaman
JUDUL ........................................................................................................ i
LEMBAR PENGESAHAN ........................................................................ ii
KATA PENGANTAR .................................................................................. iii
DAFTAR ISI ............................................................................................... v
DAFTAR TABEL........................................................................................ vii
DAFTAR GAMBAR .................................................................................. viii
DAFTAR LAMPIRAN ............................................................................... ix
BAB I PENDAHULUAN ........................................................................... 1
1.1 Latar Belakang ..................................................................................... 1
1.2 Tujuan .................................................................................................. 2
1.3 Manfaat ................................................................................................ 2
1.4 Pelaksanaan Kegiatan .......................................................................... 3
BAB II TINJAUAN PUSTAKA ................................................................. 4
2.1 Industri Farmasi .................................................................................... 4
2.1.1 Pengertian Industri Farmasi ............................................................... 4
2.1.2 Persyaratan Industri Farmasi.............................................................. 4
2.1.3 Perizinan Industri Farmasi.................................................................. 5
2.1.3.1 Izin Prinsip Industri Farmasi............................................................ 5
2.1.3.2 Izin Industri Farmasi........................................................................ 7
2.1.4 Pembinaan dan Pengawasan Industri Farmasi.................................... 9
2.1.5 Pencabutan Izin Usaha Industri Farmasi............................................ 10
2.2 Cara Pembuatan Obat yang Baik.......................................................... 10
2.2.1 Manajemen Mutu................................................................................ 11
2.2.2 Personalia............................................................................................ 12
2.2.3 Bangunan dan Fasilitas....................................................................... 12
2.2.4 Peralatan............................................................................................. 13
2.2.5 Sanitasi dan Higiene........................................................................... 14
2.2.6 Produksi.............................................................................................. 14
2.2.7 Pengawasan Mutu............................................................................... 18
2.2.8 Inspeksi Diri, Audit Mutu dan Audit Persetujuan Pemasok.......... 19
2.2.9 Penanganan Keluhan Terhadap Produk dan Penarikan Kembali
Produk................................................................................................. 20
2.2.10 Dokumentasi.................................................................................... 21
2.2.11 Pembuatan dan Analisis Berdasarkan Kontrak................................ 22
2.2.12 Kualifikasi dan Validasi................................................................... 23
2.3 Registrasi Sediaan Farmasi .................................................................. 25
2.3.1 Persyaratan Obat Yang Beredar di Indonesia..................................... 25
2.3.2 Kategori Registrasi............................................................................. 25
2.3.3 Masa Berlaku Izin Edar...................................................................... 26
BAB III PT. KIMIA FARMA (Persero) Tbk............................................. 27
3.1 Tinjauan Umum PT. Kimia Farma (Persero) Tbk................................. 27
3.1.1 Sejarah Perusahaan............................................................................. 27
3.1.2 Visi dan Misi Perusahaan................................................................... 28
3.1.2.1 Visi Perusahaan.............................................................................. 28

v
3.1.2.2 Misi Perusahaan............................................................................. 28
3.1.2.3 Budaya Perusahaan........................................................................ 28
3.1.2.4 Ruh Perusahaan.............................................................................. 29
3.1.3 Production Plant................................................................................. 30
3.1.3.1 Plant Jakarta, DKI Jakarta............................................................. 30
3.1.3.2 Plant Bandung, Jawa Barat............................................................ 30
3.1.3.3 Plant Semarang, Jawa Tengah....................................................... 30
3.1.3.4 Plant Watudakon, Jombang, Jawa Timur...................................... 30
3.1.3.5 Plant Medan, Sumatera Utara........................................................ 30
3.1.4 Anak Perusahaan PT. Kimia Farma.................................................... 31
3.2 Tinjauan Khusus PT. Kimia Farma (Persero) Tbk. Plant Medan......... 31
3.2.1 Personalia............................................................................................ 31
3.2.2 Letak dan Lokasi................................................................................ 32
3.2.3 Bangunan dan Fasilitas....................................................................... 32
3.2.4 Sanitasi dan Higiene........................................................................... 35
3.2.5 Pengendalian Proses Produksi (PP).................................................... 36
3.2.6 Produksi.............................................................................................. 37
3.2.7 Pengawasan Selama Proses (In Process Control).............................. 46
3.2.8 Pengawasan Mutu............................................................................... 47
3.2.9 Pemeriksaan Mutu Bahan Baku dan Bahan Pengemas...................... 48
3.2.10 Pemastian Mutu................................................................................ 48
3.3 Pengolahan Limbah.............................................................................. 49
3.3.1 Pengolahan Limbah Cair.................................................................... 49
3.3.2 Pengolahan Limbah Padat.................................................................. 51
3.4 Sistem Pengolahan Air.......................................................................... 51
3.5 Sistem Tata Udara (AHU/HVAC)......................................................... 52
3.6 Produk-Produk...................................................................................... 53
3.6.1 Produk-Produk PT. Kimia Farma....................................................... 53
3.6.2 Produk-Produk PT. Kimia Farma Plant Medan................................. 53
3.7 Kesehatan dan Keselamatan Kerja (K3)............................................... 54
3.7.1 Kecelakaan Kerja................................................................................ 54
3.7.2 Upaya Pengendalian K3 pada PT. Kimia Farma................................ 55
BAB IV PEMBAHASAN.......................................................................... 59
BAB V KESIMPULAN DAN SARAN..................................................... 67
5.1 Kesimpulan........................................................................................... 51
5.2 Saran..................................................................................................... 52
DAFTAR PUSTAKA................................................................................... 68
LAMPIRAN................................................................................................. 69

vi
 DAFTAR TABEL

Tabel Halaman
1. Kelas Kebersihan Ruangan ................................................................ 13
2. Produk Salep, Krim, Tablet dan Kapsul Generik PT. Kimia Farma
Plant Medan....................................................................................... 53

vii
 DAFTAR GAMBAR

Gambar Halaman
1. Alur permohonan izin prinsip industri farmasi .................................... 5
2. Alur permohonan izin industri farmasi............................................... 7
3. Denah Lokasi PT. Kimia Farma (Persero) Tbk. Plant Medan........... 32
4. Denah Instalasi Pengolahan Limbah Cair PT. Kimia Farma (Persero)
Tbk. Plant Medan............................................................................... 49

viii
 DAFTAR LAMPIRAN

Lampiran Halaman
1. Struktur Organisasi PT. Kimia Farma (Persero) Tbk. Plant Medan
........................................................................................................... 69
2. Bagan Proses Pembuatan Krim.......................................................... 70
3. Bagan Proses Pembuatan Salep.......................................................... 71
4. Bagan Proses Pembuatan Tablet......................................................... 72
5. Bagan Proses Pembuatan Kapsul....................................................... 73

ix