RENCANA PROPOSAL INDUSTRI FARMASI

“Obat Tradisional”

DOSEN :

Prof. Dr. Teti Indrawati, M.Si., Apt

Disusun Oleh :

Kelompok 14 - Apoteker XXXI B (Reguler)

Disusun Oleh :

1. Rizki Nasrullah (19340208)

2. Dony Hermanto (19340209)

PROGRAM STUDI PROFESI APOTEKER

FAKULTAS FARMASI
INSTITUT SAINS DAN TEKNOLOGI NASIONAL
JAKARTA
2020

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 DAFTAR ISI
Judul................................................................................................................. i
Daftar isi ......................................................................................................... ii
BAB I PENDAHULUAN ............................................................................... 1
I.1. Latar Belakang ........................................................................................... 1
I.2. Perumusan Masalah .................................................................................... 2
I.3. Tujuan ......................................................................................................... 2
BAB II TINJAUAN PUSTAKA .................................................................... 3
2.1. Definisi Industri Farmasi ............................................................................ 3
2.2. Persyaratan Industri Farmasi ...................................................................... 4
2.3. Obat Tradisional ......................................................................................... 5
2.4. Penggolongan Industi Bahan Alam ........................................................... 6
2.4.1. Bentuk Industri ................................................................................. 6
2.4.2. Bentuk Usaha ................................................................................... 6
2.4.3. Penyelenggara Golongan Industri .................................................... 6
2.5. Pelayanan Izin Pendirian Industri Obat Tradisional.................................... 7
2.6 Aspek - Aspek CPOTB Pada Industri Obat Tradisional ............................. 7
2.6.1. Personalia......................................................................................... 7
2.6.2. Sarana dan prasarana Bangunan....................................................... 7
2.6.3. Sarana dan prasarana Peralatan......................................................... 8
2.6.4. Sanitasi dan Hygine........................................................................... 8
2.6.5. Peyiapan Bahan Baku....................................................................... 10
2.6.6 Pengolahan dan Pengemasan ............................................................ 11

2.6.7 Pengawasan Mutu.............................................................................. 13

2.6.8. Inspeksi Diri...................................................................................... 14
2.6.9. Dokumentasi..................................................................................... 14
2.6.10. Penangan terhadap Produk Jadi Di Pasaran.................................... 15
BAB III PEMBAHASAN ............................................................................... 16
3.1. Pendirian Industri Obat Tradisional ............................................................ 16
3.2. Persyaratan Industri Obat Tradisional ........................................................ 17
3.2.1. Persyaratan Bangunan....................................................................... 17
3.2.2. Persyaratan Ruangan ........................................................................ 20
3.2.3. Persyaratan Persetujuan Prinsip ....................................................... 22

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 3.2.4. Persyaratan Perpanjangan Persetujuan Prinsip ................................. 23
3.2.5. Persyaratan Permohonan Izin OIT/IEBA ......................................... 23
3.2.6. Persyaratan Legalisir Izin ................................................................. 23
3.2.7. Perubahan Izin (ADDENDUM) ....................................................... 23
3.2.8. Syarat Pergantian Penanggung Jawab .............................................. 24
3.2.9 Persyaratan Perubahan Kapasitas Atau Fasilitas Produksi ............... 24
3.2.10. Persyaratan Perubahan Alamat Dilokasi Yang Sama .................... 24
3.3. Alur Perizinan Pendirian Industri Obat Tradisional ................................... 25
3.3.1. Permohonan Izin IOT/IEBA ............................................................ 25
3.3.2. Alur Penerbitan Izin IOT/IEBA ....................................................... 26
3.4. Alur Perizinan Pendirian UKOT ................................................................ 27
3.5. Alur Perizinan Pendirian UMOT ................................................................ 28
3.6. Produksi ..................................................................................................... 29
3.6.1. Departemen Produksi .......................................................................... 29
3.6.2. Alur Produksi ...................................................................................... 31
BAB IV KESIMPULAN .......................................................................................... 33
DAFTAR PUSTAKA ............................................................................................... 3

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