DAFTAR ISI

Halaman

HALAMAN SAMPUL................................................................................... i

HALAMAN PENGESAHAN ....................................................................... ii

KATA PENGANTAR .................................................................................. iii

DAFTAR ISI................................................................................................... v

DAFTAR GAMBAR ..................................................................................... x

DAFTAR TABEL .......................................................................................... xi

BAB I PENDAHULUAN .............................................................................. 1

1.1. Pendahuluan.......................................................................................... 1

1.2. Tujuan PKPA Industri .......................................................................... 3

1.3. Manfaat PKPA Industri ........................................................................ 3

BAB II TINJAUAN PUSTAKA.................................................................... 5

2.1. Industri Farmasi Dan Industri Obat Tradisional (IOT) ........................ 5

2.1.1. Pengertian Industri Farmasi dan Industri Obat Tradisional........ 7

2.1.2. Izin Usaha Industri Farmasi dan Industri Obat Tradisional........ 6

2.2. Cara Pembuatan Obat Yang Baik ........................................................ 9

2.2.1. Sistem Mutu Industri Farmasi..................................................... 9

2.2.2. Personalia.................................................................................... 10

2.2.3. Bangunan Dan Fasilitas.............................................................. 11

2.2.4. Peralatan...................................................................................... 14

2.2.5. Sanitasi Dan Hygiene.................................................................. 15

2.2.6. Produksi...................................................................................... 15

2.2.7. Cara Menyimpan Dan Pengiriman Obat Yang Baik................... 17

2.2.8. Pengawasan Mutu....................................................................... 18

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 2.2.9. Inpeksi Diri, Audit Mutu dan Audit Serta Persetujuan Pemasok 18

2.2.10. PEnggunaan Keluahan Produk dan Penarikan Kembali Produk 19

2.2.11. Dokumentasi............................................................................. 20

2.2.12. Pembuatan dan Analisis Berdasarkan Kontrak......................... 21

2.2.13. Kualifikasi dan Falidasi............................................................ 21

2.2.14. Sampel Pembanding dan Sampel Pertinggal............................ 24

2.3. Cara Pembuatan Obat Tradisional Yang Baik (CPOTB)...................... 25

2.3.1. Manajemen Mutu........................................................................ 26

2.3.2. Personalia.................................................................................... 27

2.3.3. Bangunan, Fasilitas dan Peralatan.............................................. 28

2.3.4. Sanitasi dan Hygiene................................................................... 31

2.3.5. Dokumentasi............................................................................... 32

2.3.6. Produksi...................................................................................... 32

2.3.7. Pengawasan Mutu....................................................................... 33

2.3.8. Pembuatan dan Analisis Berdasarkan Kontrak........................... 34

2.3.9. Cara Penyimpanan dan Pengiriman Obat Tradisional yang Baik 34

2.3.10. Penanganan Keluhan Terhadap Produk , Penarikan Kembali

Produk dan Produk Kembalian................................................. 35

2.3.11. Inspeksi Diri.............................................................................. 36

2.4. Persyaratan Mutu Obat Tradisional...................................................... 37

2.5. Peran Apoteker Di Industri Farmasi..................................................... 38

2.5.1. Apoteker Sebagai Penanggung Jawab Pengawasan Mutu

(Quality Control)........................................................................ 38

2.5.2. Apoteker Sebagai Penanggung Jawab Pemastian Mutu

(Quality Control)........................................................................ 39

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 2.5.3. Apoteker Sebagai Penanggung Jawab Produksi......................... 40

2.5.4. Departemen PPIC........................................................................ 40

2.5.5. Quality Management Representative (QMR).............................. 41

2.5.6. Departemen PD & Registrasi...................................................... 41

BAB III RUANG LINGKUP PT BALATIF................................................ 42

3.1. Sejarah PT. Balatif ............................................................................... 42

3.2. Visi dan Misi PT. Balatif ..................................................................... 43

3.2.1. Visi ............................................................................................. 43

3.2.2. Misi ............................................................................................ 43

3.3. Struktur Organisasi ............................................................................... 44

3.4. Layout PT. Balatif ................................................................................ 45

3.6. Sarana Produksi .................................................................................... 46

3.7. Jenis Produk ......................................................................................... 47

BAB IV LAPORAN PELAKSANAAN KEGIATAN DAN LAPORAN . .

KHUSUS ………………………………………………………….. 52

4.1. Timeline Pelaksanaan................................................................................ 52

4.2. Tugas Khusus ............................................................................................ 57

4.2.1. Judul Tugas Khusus.......................................................................... 57

4.2.2. Pendahuluan...................................................................................... 57

4.2.3 Tujuan ............................................................................................... 58

4.2.4. Tinjauan Pustaka .............................................................................. 58

4.2.4.1. Tanaman Cengkeh (Syzygium aromaticum L)............................ 58

4.2.4.2. Kramatograpi Lapis Tipis........................................................... 60

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 4.2.5. Prosedur Kerja Identifikasi Simplisia .............................................. 61

4.2.5.1. Identifikasi Pemerian.................................................................. 61

4.2.5.2. Identifikasi Makroskopik............................................................ 61

4.2.5.3. Identifikasi Mikroskopik............................................................ 61

4.2.5.4. Identifikasi Uji Kimiawi............................................................. 62

4.2.5.5. Uji Kadar Air.............................................................................. 63

4.2.6. Hasil Pengujian ................................................................................ 63

4.2.6.1. Pemerian..................................................................................... 63

4.2.6.2. Makroskopi................................................................................. 63

4.2.6.3. Kadar Air.................................................................................... 63

4.2.6.4. Pola Kromatografi...................................................................... 64

4.2.7. Pembahasan ..................................................................................... 64

4.2.8. Kesimpulan ...................................................................................... 65

4.2.9. Pustaka ............................................................................................. 65

BAB V PEMBAHASAN................................................................................. 66

5.1. Manajemen Mutu ...................................................................................... 66

5.2. Personalia .................................................................................................. 67

5.3. Bangunan, Fasilitas dan Peralatan ............................................................ 67

5.3.1. Sistem HVAC (Heating Ventilation Air Conditioning).................... 68

5.3.2. Sistem Pengolahan Air (SPA).......................................................... 69

5.4. Sanitasi Higiene ........................................................................................ 71

5.5. Dokumentasi ............................................................................................. 72

5.6. Produksi .................................................................................................... 72

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5.7. Pengawasan Mutu ..................................................................................... 76

5.8. Pembuatan dan Analisa Berdasarkan Kontrak ......................................... 77

5.9. Cara Penyimpanan dan Pengiriman Obat Tradisional .............................. 77

5.10. Penanganan Keluhan Terhadap Produkdan Penarikan Kembali Produk 77

5.11. Inspeksi Diri ............................................................................................ 78

BAB V KESIMPULAN.................................................................................. 79

6.1. Kesimpulan ............................................................................................... 79

6.2. Saran ......................................................................................................... 79

DAFTAR PUSTAKA...................................................................................... 81

LAMPIRAN.................................................................................................... 83

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 DAFTAR GAMBAR

Halaman

Gambar 2.1 Contoh Struktur Organisasi........................................................ 11

Gambar 3.1 Struktur Organisasi PT. Balatif.................................................. 44

Gambar 3.2 Denah PT. Balatif Divisi Herbal Pakis....................................... 45

Gambar 4.1 Tanaman Cengkeh (Syzygium Aromaticum L)........................... 59

Gambar 4.2 Struktur Kimia Flavanoid Sumber.............................................. 60

Gambar 4.3 Simplisia Cengkeh...................................................................... 61

Gambar 4.4 Mikroskopik simplisia bunga cengkeh (a) serbuk sari lepas,

(b) kelenjar minyak skizolisigen, (c) berkas pembuluh dan

serabut sklerenkim, (d) epidermis dasar bunga, (e) sel batu

dan sklereida ………………………………………………….. 62

Gambar 4.5 Pola Kromatografi dengan fase gerak Etil asetat - Asam Format

- Asam Asetat - Air (100 : 11 : 11 : 26 ……………………….. 64

Gambar 5.1 Sistem Pengolahan Limbah Cair PT. Balatif.............................. 71

Gambar 5.2 Alur Produksi.............................................................................. 75

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 DAFTAR TABEL

Halaman

Tabel 2.1 Klasifikasi Kelas Kebersihan......................................................... 13

Tabel 3.1 Jenis Produk Herbal Di PT. Balatif................................................ 48

Tabel 3.2 Jenis Produk Obat Farma Di PT. Balatif........................................ 50

Tabel 3.3 Jenis Produk Suplemen Di PT. Balatif........................................... 51

Tabel 4.1 Timeline Pelaksanaan..................................................................... 52

Tabel 5.1 Parameter Monitoring HVAC........................................................ 69

Tabel 5.2 Spesifikasi Air................................................................................ 70

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