PENGANTAR
PREFACE
Sejalan
dengan
perkembangan
ilmu
pengetahuan dan teknologi di bidang
farmasi, Pedoman CPOB edisi pertama
sekaligus Petunjuk Operasional Penerapan
CPOB telah direvisi pada tahun 2001 yang
terdiri dari 10 bab dan 3 addendum.
Selanjutnya untuk mengantisipasi era
globalisasi dan harmonisasi dalam bidang
farmasi terutama pemenuhan terhadap
persyaratan dan standar produk farmasi
global terkini, Pedoman CPOB hendaklah
diperbaiki
secara
berkesinambungan
mengikuti perkembangan ilmu pengetahuan
dan teknologi serta pergeseran paradigma
dalam melakukan pengawasan terhadap
mutu produk. Oleh karena itu, Pedoman
CPOB Edisi 2001 direvisi kembali menjadi
Pedoman CPOB yang dinamis Edisi Tahun
2006.
Edisi 2006
-i-
2006 - Edition
Edisi 2006
- ii -
2006 Edition
Advisor
Chairman
2. DeputiBidang Pengawasan
Produk Terapetik dan NAPZA
Ketua
Anggota
Members
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
23.
Edisi 2006
- iii -
2006 Edition
DAFTAR
ISI
TABLE OF CONTENT
Page
Halaman
PENGANTAR ...................................
P R E F A C E ........................................
iv
iv
PENDAHULUAN...............................
Prinsip ............................................
Umum.............................................
1
1
1
INTRODUCTION ...................................
Principle..............................................
General...............................................
1
1
1
3
4
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11
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22
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25
Principle ............................................
General .............................................
Weighing Areas .................................
Production Areas ..............................
Storage Areas ...................................
Quality Control Areas ........................
Ancillary Areas ..................................
17
17
19
19
22
24
25
26
26
26
28
28
CHAPTER 4 - EQUIPMENT...................
Principle ............................................
Design and Construction ...................
Installation and Location ....................
Maintenance ......................................
26
26
26
28
28
30
30
30
30
32
34
Prinsip.............................................
Higiene Perorangan........................
Sanitasi Bangunan dan Fasilitas ....
Pembersihan dan Sanitasi Peralatan.
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Daftar Isi
Edisi 2006
Table of Content
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Line Clearance.............................. 54
Packaging Practices ..................... 54
Completion of the Packaging
Operations .................................... 57
In-process Control ............................. 58
Rejected, Recovered and Returned
Materials ............................................ 59
Finished Product Quarantine and
Delivery to Finished Stock ................. 61
Control Record for Shipment of
Pharmaceutical Products .................. 63
Storage of Starting Materials, Packaging
Materials, Intermediates, Bulk Products
and Finished Product......................... 63
Storage of Starting Materials and
Packaging Materials..................... 65
Storage of Intermediate, Bulk
and Finished Products ................. 66
Dispatch and Transport ..................... 66
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59
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63
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66
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Daftar Isi
Table of Content
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Reprocessing ................................
Quality Control Evaluation on
Production Procedures .................
Stability Study ...............................
83
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85
86
86
86
87
87
87
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Daftar Isi
Table of Content
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Dokumen Produksi.....................
Dokumen Produksi Induk ...........
Prosedur Pengolahan Induk ......
Prosedur Pengemasan Induk ....
Catatan Pengolahan Bets ..........
Catatan Pengemasan Bets ........
Prosedur dan Catatan................
Penerimaan ........................
Pengambilan Sampel..........
Pengujian............................
Lain-lain ..............................
100
101
101
102
103
104
106
106
106
107
107
CHAPTER 11 CONTRACT
MANUFACTURE AND
ANALYSIS
Principle ..........................................
General ...........................................
The Contract Giver .........................
The Contract Acceptor ....................
The Contract ...................................
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117
Concurrent Validation ............... 118
118
Retrospective Validation........... 119
119
120
121
121
122
Cleaning Validation..........................
Change Control ...............................
Revalidation.....................................
Validation of Analytical Procedures ..
Types of Analytical Procedure
to be Validated.
122
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2006 - Edition
Daftar Isi
Table of Content
ANEKS
ANEKS 1 - PEMBUATAN PRODUK
STERIL..............................
ANNEXES
125
Prinsip
...............................
125
Umum
...............................
125
Teknologi Isolator.................... .... 130
Teknologi Peniupan / Pengisian/
Penyegelan .............................. .... 131
Produk yang Disterilisasi Akhir .... 131
Pembuatan Secara Aseptis .......... 132
Personil .................................... 133
Bangunan dan Fasilitas ................ 136
Peralatan .................................... 139
Sanitasi
.................................... 140
Air ................................................. 141
Pengolahan................................... 142
Sterilisasi ...............................
145
Sterilisasi Akhir ...................... 147
Sterilisasi Cara Panas ........... 147
Sterilisasi Cara Panas Basah 148
Sterilisasi Cara Panas kering. 149
Sterilisasi Dengan Cara
Radiasi................................... 149
Sterilisasi Dengan Gas dan
Fumigan................................. 151
Filtrasi Obat yang Tidak
Dapat Disterilkan Dalam
Wadah Akhirnya......................... 152
Indikator Biologis dan Kimiawi ... 154
Penyelesaian Produk Steril........ 155
Pengawasan Mutu ..................... 155
ANEKS 2 - PRODUKSI PRODUK
BIOLOGI...........................
Ruang Lingkup...........................
Prinsip .......................................
Personil......................................
Bangunan, Fasilitas dan
Peralatan ...................................
Sarana Pemeliharaan dan
Penanganan Hewan ..................
Dokumentasi ..............................
Produksi.....................................
Bahan Awal..............................
Lot Benih dan Sistem Bank Sel
Prinsip Kerja ............................
Pengawasan Mutu .....................
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131
132
133
136
139
140
141
142
145
147
147
148
149
149
157
157
157
158
159
159
Animal Quarters and Care .............. 162
162
163
163
163
163
165
166
Documentation ...............................
Production ......................................
Starting Materials .........................
Seed Lot and Cell Bank System ..
Operating Principles .....................
Quality Control ................................
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Daftar Isi
Table of Content
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167
ANNEX 3 - MANUFACTURE OF
MEDICINAL GASES 167
Principle . 167
Personnel 167
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170
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177
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