DAFTAR ISI

LEMBAR PENGESAHAN
KATA PENGANTAR ......................................................................................... ..i
DAFTAR ISI .........................................................................................................ii
BAB I. PENDAHULUAN
1.1 Latar Belakang ............................................................................................ ...1
1.2 Tujuan ............................................................................................................2
BAB II. PROFIL PT. MUTIFA
2.1 Sejarah PT. MUTIFA ......................................................................................3
2.2 Visi dan Misi Perusahaan ...............................................................................4
2.3 Struktur Organisasi ........................................................................................4
BAB III. CARA PEMBUATAN OBAT YANG BAIK
3.1 Manajemen Mutu .........................................................................................10
3.2 Pengawasan Mutu (QC) .............................................................................. 12
3.2.1 Pengkajian Mutu Produk ................................................................... 14
3.3 Personalia ................................................................................................... 15
3.3.1 Pelatihan ........................................................................................... 16
3.4 Bangunan dan Fasilitas ............................................................................... 17
3.5 Peralatan .................................................................................................... 20
3.5.1 Rancang bangun dan Kontruksi ........................................................ 20
3.5.2 Pemasangan dan penempatan ......................................................... 21
3.5.3 Pemeliharaan .................................................................................... 21
3.6 Sanitasi dan Hygiene .................................................................................. 22
3.7 Produksi ...................................................................................................... 23
3.7.1 Bahan Awal ....................................................................................... 23
3.7.2 Proses validasi .................................................................................. 27
3.7.3 Pencemaran ...................................................................................... 28
3.7.4 Sistem Penomoran Bets dan Lot ....................................................... 28
3.7.5 Penimbangan dan Penyerahan ........................................................ 28
3.7.6 Pengambilan ..................................................................................... 30
3.7.7 Pengolahan ...................................................................................... 30
3.7.8 pengemasan ..................................................................................... 31
3.8 Inspeksi diri dan Audit Mutu ........................................................................ 32
3.8.1 Aspek untuk Inspeksi Diri .................................................................. 32
3.8.2 Tim Inspeksi Diri ................................................................................ 32
 3.8.3 Cakupan dan Frekuensi Inspeksi Diri ................................................ 33
3.8.4 Laporan Inspeksi Diri ......................................................................... 33
3.8.5 Tindak Lanjut..................................................................................... 33
3.8.6 Audit Mutu ......................................................................................... 33
3.8.7 Audit dan Persetujuan Pemasok ....................................................... 33
3.9 Penanganan Keluhan Konsumen Terhadap Produk, Penarikan kembali Produk
dan Produk Kembalian ................................................................................. 34
3.10 Dokumentasi ............................................................................................. 37
3.10.1 Ketentuan Umum ............................................................................ 38
3.10.2 Spesifikasi ....................................................................................... 39
3.11 Pembuatan dan Analisis Berdasarkan Kontrak ......................................... 39
3.12 Kualifikasi dan Validasi.............................................................................. 43
BAB IV. TINJAUAN PT. MUTIARA MUKTI FARMA MEDAN
4.1 Aspek Manajemen Mutu ............................................................................. 44
4.2 Aspek Pengawasan Mutu............................................................................ 46
4.3 Aspek Personalia ........................................................................................ 47
4.3.1 Jumlah Karyawan ............................................................................... 47
4.3.2 Struktur Organisasi PT. MUTIFA Medan ............................................ 48
4.4 Aspek Bangunan dan Fasilitas .................................................................... 48
4.5 Aspek Peralatan .......................................................................................... 50
4.6 Aspek Sanitasi dan Higiene ........................................................................ 50
4.7 Aspek Produksi ........................................................................................... 51
4.7.1 Bentuk Sediaan .................................................................................. 51
4.7.2 Kapasitas Produksi............................................................................. 51
4.7.3 Area Produksi..................................................................................... 52
4.7.4 Pengolahan Limbah ............................................................................ 55
4.8 Aspek Inspeksi Diri dan Audit Mutu ............................................................. 59
4.9 Aspek Penanganan Keluhan terhadap Produk,Penarikan Produk dan
Produk Kembalian ...................................................................................... 60
4.10 Aspek Dokumentasi .................................................................................. 60
4.11 Aspek Pembuatan dan Analisa berdasarkan Kontrak ................................ 61
4.12 Aspek Kualifikasi dan Validasi ................................................................... 61
BAB V. PEMBAHASAN
5.1 Aspek Manajemen Mutu.............................................................................. 62
5.2 Aspek Pengawasan Mutu............................................................................ 62
5.3 Aspek Personalia ........................................................................................ 62
5.4 Aspek Bangunan dan Fasilitas .................................................................... 63
5.5 Aspek Peralatan.......................................................................................... 64
5.6 Aspek Sanitasi dan Higiena ........................................................................ 64
5.7 Aspek Produksi ........................................................................................... 65
5.8 Aspek Inspeksi Diri dan Audit Mutu ............................................................. 66
5.9 Aspek Penanganan Keluhan terhadap Produk,Penarikan Produk dan
Produk Kembalian ........................................................................................ 66
5.10 Aspek Dokumentasi .................................................................................. 67
5.11 Aspek Pembuatan dan Analisa berdasarkan Kontrak ................................. 67
5.12 Aspek Kualifikasi dan Validasi .................................................................... 67
BAB VI. KESIMPULAN DAN SARAN
6.1 Kesimpulan ................................................................................................. 68
6.2 Saran .......................................................................................................... 68
DAFTAR PUSTAKA ......................................................................................... 69
LAMPIRAN