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PEDOMAN

CARA PEMBUATAN OBAT YANG BAIK


GUIDELINES ON GOOD MANUFACTURING

Badan Pengawas Obat dan Makanan


National Agency of Drug and Food Control
Republik Indonesia
Republic of Indonesia
2006

PENGANTAR

PREFACE

Pedoman Cara Pembuatan Obat yang Baik


(CPOB) pertama kali diterbitkan pada tahun
1988, kemudian disusul dengan penerbitan.
Petunjuk Operasional Penerapan CPOB
pada tahun 1989 untuk memberikan
penjelasan dalam penjabaran sehingga
Pedoman ini dapat diterapkan secara efektif
di industri farmasi.

The Indonesian Good Manufacturing Practice


(GMP) guidelines for pharmaceuticals was first
developed in 1988 and enforced since 1989. To
make the guidelines effectively applicable and
implementable, an Operational Manual for GMP
Implementation was then developed in 1989.

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.

Due to the rapid development of science and


technology in the pharmaceutical field, the first
edition of GMP Guidelines was revised in 2001
which consisted of 10 chapters and 3 addenda.
To
anticipate
globalisation
era
and
harmonisation within the pharmaceutical sector
particularly in compliance with the current
requirements and standards
of global
pharmaceutical products, the GMP Guidelines
should continuously be updated in line with the
development of science and technology. Thus,
the GMP Guidelines 2001 Edition is again
revised to the current GMP Guidelines 2006
Edition.

Dibandingkan dengan edisi sebelumnya,


Pedoman CPOB Edisi 2006 mengandung
perbaikan
sesuai
persyaratan
CPOB
dinamis, antara lain Kualifikasi dan
Validasi, Pembuatan dan Analisis Obat
Berdasarkan Kontrak, Pembuatan Produk
Steril dan penambahan beberapa bab serta
aneks yaitu Manajemen Mutu, Pembuatan
Produk Darah, Sistem Komputerisasi, dan
Pembuatan Produk Investigasi untuk Uji
Klinis.

The previous guidelines is improved by


updating with the current GMP requirements,
among others for Qualification and Validation,
Contract
Manufacture
and
Analysis,
Manufacturing
of Sterile
Pharmaceutical
Products and addition of new chapters and
annexes for Quality Management System,
Manufacture of Blood Products, Manufacture of
Investigational Products for Clinical Trial and
Computerised System.

Dalam Pedoman CPOB Edisi Tahun 2006,


acuan yang digunakan antara lain WHO
Technical Report Series yakni TRS
902/2002, TRS 908/2003, TRS 929/2005,
dan TRS 937/2006, Good Manufacturing
Practices for Medicinal Products PIC/S 2006,

References used for revision of this GMP


Guidelines are WHOTRS 902/2002, WHO
TRS 908/2003, WHOTRS 929/2005, WHO
TRS 937/2006, Guide to GMP for Medicinal
Products PIC/S 2006 and other International
GMP Codes.

Edisi 2006

-i-

2006 - Edition

dan international codes of GMP lain.

Pedoman CPOB akan dikaji ulang secara


periodis dan direvisi, bila perlu.

The GMP Guidelines will be updated


periodically and revised as necessary.

Diharapkan penerapan Pedoman CPOB ini


akan
meningkatkan
mutu
produk
farmasi/obat secara terus menerus serta
memberikan perlindungan yang lebih baik
terhadap kesehatan masyarakat. Akhirnya
akan menjadi langkah progresif terhadap
perkembangan industri farmasi di Indonesia
sehingga mutu obat mendapat pengakuan
dan kepercayaan internasional.

Implementation of this GMP Guidelines is


expected to continually improve the quality of
pharmaceutical products and subsequently
provide better protection to the public health.
Additionally the GMP Guidelines should be a
progressive step towards the development of
the Indonesian pharmaceutical industries
capability to produce quality drug products that
receive international recognition and trust.

Penghargaan dan ucapan terima kasih kami


sampaikan khususnya kepada Tim Revisi
Buku Pedoman dan Petunjuk Operasional
CPOB Edisi Tahun 2006 yang telah
memberikan sumbangan pikiran, waktu dan
tenaga mereka sehingga memungkinkan
penerbitan Pedoman CPOB ini yang
diharapkan dapat mempercepat penyebaran
upaya penerapan CPOB bagi industri
farmasi di Indonesia.Tim Revisi Buku
Pedoman dan Petunjuk Operasional CPOB
Edisi Tahun 2006 tersebut ditunjuk dalam
Surat Keputusan Kepala Badan Pengawas
Obat dan Makanan No.HK.00.06.0511,
Tanggal 24 Januari 2006.

We would like to express our appreciation and


gratitude to the National GMP Team for
Revision of GMP Guidelines and Operation
Manual for Implementation of GMP Edition 2006
who have given valuable contribution on ideas,
their time and energy, to enable the publication
of this GMP Guidelines which is expected to
accelerate the implementation of current GMP
requirements in the pharmaceutical industries in
Indonesia. The GMP Team for Revision of GMP
Guidelines
and
Operation
Manual
for
Implementation of GMP 2006 Edition was
appointed by the Head of National Agency of
Drug and Food Control under Decree No
No.HK.00.06.0511, dated 24 Januari 2006.

Kami juga mengucapkan banyak terima


kasih kepada semua pihak yang mendukung
dan berpartisipasi baik secara langsung atau
tidak langsung dalam penyusunan dan
penerbitan buku Pedoman CPOB ini.

We would like to express our gratitude and


respect to all other contributors, staf of National
Agency of Drug and Food Control and other
participants who are directly or indirectly
involved in revising this GMP Guidelines

Deputi Bidang Pengawasan


Produk Terapetik dan NAPZA,
Deputy for Therapeutic Products, Narcotics,
Psycotropics and Addictive Substances Control,

Dra. Lucky S. Slamet, M. Sc.


NIP 140099151

Edisi 2006

- ii -

2006 Edition

TIM REVISI BUKU PEDOMAN CPOB


EDISI 2006
Pengarah

GMP REVISION TEAM FOR


THE 2006 EDITION

: 1. Kepala Badan POM

Advisor

: 1. Head of National Agency of Drug


and Food Control
2. Deputy of Therapeutic Products,
Narcotics, Psychotropics and
Addictive Substances Control

Chairman

: Director for Control of Production of


Therapeutic Products and Household
Products

2. DeputiBidang Pengawasan
Produk Terapetik dan NAPZA

Ketua

: Direktur Pengawasan Produksi


Produk Terapetik dan PKRT.

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

Amin Sjaugi, Drs.


Berni Somalinggi, Dra.
Daniel Santoso, Dr.
Elis Sukmawati, Dra.
Herny Prasetya, Dra.
Kustantinah, Dra.
Lina Astuti, Dra, M.Med.Sc.
Mahendra, Drs.
M. Sumarno, Drs.
Mudi Yunita Bukit, Dra.
Oenggoel Pribudhi, Drs.
Pawitra Kresno, Dra.
Ratna Sosialin, Dra.
Retno Utami, Dra.
Rudy F. B. Mantik, Drs.
Rumondang Simanjuntak, Dra.
Sumaria Sudian, Dra.
Tanusoma Widjaja, Drs.
Togi Hutadjulu, Dra., MHA
Uluan Sitorus. Dr.
V. Surjana, Drs.
Dra. Yuli Hastini

- iii -

2006 Edition

DAFTAR

ISI

TABLE OF CONTENT
Page

Halaman
PENGANTAR ...................................

P R E F A C E ........................................

DAFTAR ISI ......................................

iv

TABLE OF CONTENT ...........................

iv

PENDAHULUAN...............................
Prinsip ............................................
Umum.............................................

1
1
1

INTRODUCTION ...................................
Principle..............................................
General...............................................

1
1
1

BAB 1 - MANAJEMEN MUTU


Prinsip.............................................
Pemastian Mutu..............................
Cara Pembuatan Obat yang
Baik (CPOB) ...................................
Pengawasan Mutu ..........................
Pengkajian Mutu Produk.................
BAB 2 - PERSONALIA ....................
Prinsip.............................................
Umum .............................................
Personil Kunci.................................
Organisasi, Kualifikasi dan
Tanggung Jawab............................
Pelatihan.........................................

CHAPTER 1 - QUALITY MANAGEMENT


Principle ............................................
Quality Assurance ............................
Good Manufacturing Practices for
Pharmaceutical Products (GMP) ......
Quality Control ..................................
Product Quality Review ....................

3
4
5
7
9
11
11
11
11
12
15

3
4
5
7
9

CHAPTER 2 - PERSONNEL .................


Principle ............................................
General .............................................
Key Personnel ..................................
Organization, Qualification and
Responsibilities .................................
Training .............................................

11
11
11
11
12
15

BAB 3 - BANGUNAN DAN


FASILITAS..........................
Prinsip.............................................
Umum .............................................
Area Penimbangan .........................
Area Produksi .................................
Area Penyimpanan .........................
Area Pengawasan Mutu .................
Sarana Pendukung .........................

CHAPTER 3 - PREMISES ....................

17

17
17
17
19
19
22
24
25

Principle ............................................
General .............................................
Weighing Areas .................................
Production Areas ..............................
Storage Areas ...................................
Quality Control Areas ........................
Ancillary Areas ..................................

17
17
19
19
22
24
25

BAB 4 - PERALATAN ........................


Prinsip ...........................................
Desain dan Konstruksi....................
Pemasangan dan Penempatan ......
Perawatan .....................................

26
26
26
28
28

CHAPTER 4 - EQUIPMENT...................
Principle ............................................
Design and Construction ...................
Installation and Location ....................
Maintenance ......................................

26
26
26
28
28

BAB 5 - SANITASI DAN HIGIENE

30

CHAPTER 5 - SANITATION AND


HYGIENE ......................
Principle ............................................
Personnel Hygiene ............................
Premises Sanitation...........................
Equipment Cleaning and Sanitation ..

30
30
30
32
34

Prinsip.............................................
Higiene Perorangan........................
Sanitasi Bangunan dan Fasilitas ....
Pembersihan dan Sanitasi Peralatan.

Edisi 2006

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30
32
34

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2006 Edition

Daftar Isi

Validasi Prosedur Pembersihan


dan Sanitasi ...................................
BAB 6 - P R O D U K S I ..................
Prinsip.............................................
Umum .............................................
Bahan Awal ...................................
Validasi Proses...............................
Pencegahan Pencemaran
Silang .............................................
Sistem Penomoran Bets/lot ............
Penimbangan dan Penyerahan ......
Pengembalian.................................
Pengolahan ....................................
Bahan dan Produk Kering...............
Pencampuran dan Granulasi ..
Pencetakan Tablet...................
Penyalutan ..............................
Pengisian Kapsul Keras ..........
Penandaan Tablet Salut
dan Kapsul ..............................
Cairan, Krim dan Salep
(non steril) .....................................
Bahan Pengemas ...........................
Kegiatan Pengemasan ...................
Pra-kodifikasi Bahan
Pengemas ...............................
Kesiapan Jalur.........................
Praktik Pengemasan ...............
Penyelesaian Kegiatan
Pengemasan.............................
Pengawasan-Selama-Proses...........
Bahan dan Produk yang Ditolak,
Dipulihkan dan Dikembalikan .........
Karantina dan Penyerahan
Produk Jadi .......................................
Catatan Pengendalian Pengiriman
Obat ..................................................
Penyimpanan Bahan Awal, Bahan
Pengemas, Produk Antara, Produk
Ruahan dan Produk Jadi ...................
Penyimpanan Bahan Awal
dan Bahan Pengemas................
Penyimpanan Produk Antara,
Produk Ruahan dan Poduk Jadi..
Pengiriman dan Pengangkutan .........
BAB 7 - PENGAWASAN MUTU .....
Prinsip .............................................
Umum..............................................
Cara Berlaboratorium Pengawasan
Mutu Yang Baik ...............................

Edisi 2006

Table of Content

Validation of Cleaning and Sanitation


Procedures ........................................

35
36
36
36
38
41

CHAPTER 6 - PRODUCTION ...............


Principle ............................................
General .............................................
Starting Materials...............................
Process Validation .............................
Prevention of Cross-Contamination in
Production ........................................
Batch and Lot Numbering System .....
Weighing and Dispensing ..................
Returns ..............................................
Processing ........................................
Dry Material and Products .................
Mixing and Granulating ................
Compression.................................
Coating .........................................
Hard Capsule Filling......................
Coated Tablet and Capsule
Printing..........................................
Liquids, Creams, and Ointments
(non-sterile) .......................................
Packaging Materials ..........................
Packaging Operations ......................
Pre-coding of Components ...........

42
43
44
45
46
47
48
49
49
50
50
50
52
53
53
54
54

35
36
36
36
38
41
42
43
44
45
46
47
48
49
49
50
50
50
52
53
53

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

57
58
59
61
63

63
65
66
66
68
68
68

CHAPTER 7- QUALITY CONTROL .....


Principle ............................................
General .............................................
Good Quality Control Laboratory
Practices ...........................................

70

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2006 - Edition

Daftar Isi

Pengawasan Bahan Awal, Produk


Antara,Produk Ruahan dan
Produk Jadi ................................... .....
Dokumentasi................................. .....
Pengambilan Sampel.................... .....
Bahan Awal ................................
Bahan Pengemas .......................
Kegiatan Pengambilan Sampel ..
Persyaratan Pengujian ...............
Pengendalian Lingkungan ....... ..
Pengawasan-Selama-Proses .....
Pengujian Ulang Bahan yang
Diluluskan ................................
Pengolahan Ulang ...................
Evaluasi Pengawasan Mutu
terhadap Prosedur Produksi ...
Studi Stabilitas............................
BAB 8 - INSPEKSI DIRI DAN
AUDIT MUTU .......................
Prinsip.............................................
Aspek Untuk inspeksi Diri ...............
Tim Inspeksi Diri .............................
Cakupan dan Frekuensi Inspeksi
Diri ..................................................
Laporan Inspeksi Diri ......................
Tindak Lanjut ..................................
Audit Mutu .....................................
Audit dan Persetujuan Pemasok ....

Table of Content

Control of Starting Materials,


Intermediate, Bulk and Finished
Products ............................................
Documentation .................................
Sampling ...........................................
Starting Materials ..........................
Packaging Materials......................
Sampling Operations ....................
Test Requirements ......................
Environment Control .....................
In-process Control.........................
Retesting of Approved Materials ...

75
76
76
77
78
78
80
81
82
82
82

Reprocessing ................................
Quality Control Evaluation on
Production Procedures .................
Stability Study ...............................

83
83

CHAPTER 8 - SELF INSPECTION AND


QUALITY AUDITS ........
Principle ............................................
Item for Self Inspection ......................
Team of Self Inspection .....................
Coverage and Frequency of Self
Inspection ..........................................
Self Inspection Report .......................
Follow - up Action ..............................
Quality Audit ......................................
Suppliers Audit and Approval............

85
85
85
86
86
86
87
87
87

75
76
76
77
78
78
80
81
82
82
82
83
83

85
85
85
86
86
86
87
87
87

BAB 9 - PENANGANAN KELUHAN TERHADAP PRODUK, PENARIKAN


KEMBALI PRODUK DAN
PRODUK KEMBALIAN ......... 89
Prinsip.............................................
89
Keluhan ..........................................
89
Penarikan Kembali Produk .............
91
Produk Kembalian ..........................
94
Dokumentasi ...................................
95

CHAPTER 9 - HANDLING OF PRODUCT


COMPLAINT, PRODUCT
RECALL AND RETURNED
PRODUCTS ................. 89
Principle............................................. 89
Complaints......................................... 89
Recalls............................................... 91
Returned Products............................. 94
Documentation .................................. 95

BAB 10 - DOKUMENTASI ................


Prinsip.............................................
Umum .............................................
Dokumen yang Diperlukan .............
Spesifikasi..................................
Spesifikasi Bahan Awal..............

96
96
96
98
98
98

Spesifikasi Bahan Pengemas ....

99

CHAPTER 10 - DOCUMENTATION .....


Principle ............................................
General .............................................
Documents Required ........................
Specifications ..............................
Specifications for Starting
Materials .......................................
Specifications for Packaging
Materials ......................................
Specifications for Intermediate
and Bulk Product...........................

Spesifikasi Produk Antara dan


Produk Ruahan ..........................

Edisi 2006

99

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96
96
98
98
98
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2006 - Edition

Daftar Isi

Table of Content

Spesifikasi Produk Jadi ..............

100

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

Specifications for Finished


Products .......................................
Production Documents..................
Master Production Document .......
Master Processing Procedure.......
Master Packaging Procedure........
Batch Processing Record .............
Batch Packaging Record ..............
Procedures and Records ..............
Receipt ................................
Sampling..............................
Testing.................................
Others..................................

BAB 11 - PEMBUATAN DAN ANALISIS


BERDASARKAN
KONTRAK .......................... 109
Prinsip............................................. 109
Umum ............................................ 109
Pemberi Kontrak ............................. 110
Penerima Kontrak.........................
110
Kontrak .......................................... 111

CHAPTER 11 CONTRACT
MANUFACTURE AND
ANALYSIS
Principle ..........................................
General ...........................................
The Contract Giver .........................
The Contract Acceptor ....................
The Contract ...................................

BAB 12 KUALIFIKASI DAN


VALIDASI ...................... ...
Prinsip...........................................
Perencanaan Validasi...................
Dokumentasi.................................
Kualifikasi .....................................
Kualifikasi Desain (KD) ............
Kualifikasi Instalasi (KI) ............
Kualifikasi Operasional (KO) .....
Kualifikasi Kinerja (KK) ..............
Kualifikasi Fasilitas, Peralatan
dan Sistem Terpasang yang
telah operasional........................
Validasi Proses .................................
Umum ........................................
Validasi Prospektif (Prospective
Validation) ..................................
Validasi Konkuren (Concurrent
Validation) ..................................
Validasi Retrospektif
(Retrospective Validation) ..........
Validasi Pembersihan .....................
Pengendalian Perubahan ...............
Validasi Ulang.................................
Validasi Metode Analisis.................
Jenis Metode Analisis yang
Divalidasi ..............................

CHAPTER 12 QUALIFICATION AND


VALIDATION ............
Principle ..........................................
Planning For Validation....................
Documentation ...............................
Qualification .....................................
Design Qualification ...............
Installation Qualification .........
Operational Qualification........
Performance Qualification......
Qualification of Established
(in-use) Facilities, Systems
and Equipment .......................
Process Validation ...........................
General.....................................
Prospective Validation ..............

Edisi 2006

113
113
113
114
114
114
115
115
116

116
116
116

100
100
101
101
102
103
104
106
106
106
107
107

109
109
109
110
110
111

113
113
113
114
114
114
115
115
116

116
116
116
117

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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121
121
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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 .....................

Edisi 2006

157
157
157
158

ANNEX 1 - MANUFACTURE OF STERILE


PHARMACEUTICAL
PRODUCTS ..................... 125
Principle .......................................... 125
General ........................................... 125
Isolator Technology ........................ 130
Blow/Fill/Seal Technology ............... 131
Terminally Sterilized Products ........
Aseptic Preparation ........................
Personnel .......................................
Premises .........................................
Equipment ......................................
Sanitation ........................................
Water ...............................................
Processing ......................................
Sterilization .....................................
Terminal Sterilization ................
Sterilization by Heat .................
Sterilization by Moist Heat .......
Sterilization by Dry Heat ..........
Sterilization by Radiation .........
Sterilization by Gases and

131
132
133
136
139
140
141
142
145
147
147
148
149
149

Fumigants ................................ 151


Filtration of Pharmaceutical Products
which cannot be Sterilized in their Final
Container ........................................ 152
Biological and Chemical Indicators .. 154
Finishing of Sterile Products ........... 155
Quality Control ................................ 155
ANNEX 2 - MANUFACTURE OF
BIOLOGICAL PRODUCTS ..
Scope .............................................
Principle ..........................................
Personnel .......................................
Premises and Equipment ................

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 ................................

- viii -

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163
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2006 - Edition

Daftar Isi

ANEKS 3 - PEMBUATAN GAS


MEDISINAL ......................
Prinsip........................................
Personil......................................
Bangunan, Fasilitas dan
Peralatan ...................................
Bangunan dan fasilitas..........
Peralatan...............................
Dokumentasi ..............................
Produksi.....................................
Produksi Produk Ruahan ......
Pengisian dan Pelabelan ......
Pengawasan Mutu .....................
Penyimpanan dan Pelulusan .....

Table of Content

167
167
167

ANNEX 3 - MANUFACTURE OF
MEDICINAL GASES 167
Principle . 167
Personnel 167

168
168
168
170
171
171
172
176
177

Premises and Equipment 168


Premises 168
Equipment168
Documentation . 170
Production . 171
Bulk Production. 171
Filling and Labeling..................... 172
Quality Control ................................ 176
Storage and Release ...................... 177
ANNEX 4 - MANUFACTURE OF
PRESSURIZED METERED DOSE
INHALER (AEROSOL) 179

ANEKS 4 - PEMBUATAN INHALASI


DOSIS TERUKUR BERTEKANAN (AEROSOL)... 179
Prinsip 179
Bangunan, Fasilitas dan
Peralatan ....................................... 179
Produksi dan Pengawasan Mutu 180

Principle .......................................... 179


Premises and Equipment ................ 179

ANEKS 5 - PEMBUATAN PRODUK


DARAH ........................... 182
Prinsip ........................................ 182
Manajemen Mutu ....................... 183
Personil dan Pelatihan ............... 183
Pengambilan Darah dan Plasma... 184
Uji Screening untuk Screening
Penanda Inspeksi .. 186
Ketertelusuran dan Tindakan
Pasca Pengambilan ...................
186
Bangunan dan Fasilitas..............
188
Area Penerimaan dan
Penyimpanan barang ............
188
Area Pembuatan ...................
188
Peralatan....................................
189
Sanitasi dan Higiene ..................
191
Higiene Perorangan ..............
191
Sanitasi Bangunan dan
Fasilitas .................................
191
Pembersihan dan Sanitasi
Peralatan...............................
192
Validasi Prosedur Pembersihan
dan Sanitasi .......................... 193
Produksi ..................................... 193
Penyediaan Komponen ......... 193
Pengolahan ........................... 193
Pelabelan .............................. 193
Pelulusan Produk .................. 194

ANNEX 5 - MANUFACTURE OF BLOOD


PRODUCTS .................... 182
Principle .......................................... 182
Quality Management........................ 183
Personnel and Training.................... 183
Blood and Plasma Collection........... 184
Screening Tests for Infectious Screening
Markers............................................ 186
Traceability and Post Collection
Measures......................................... 186
Premises.......................................... 188
Goods Receipt and Storage
Areas ........................................ 188
Manufacturing Areas............. 188
Equipment ....................................... 189
Sanitation and Hygiene.................... 191
Personnel Hygiene...................... 191
Premises Sanitation .................... 191

Edisi 2006

Production and Quality Control ....... 180

Equipment Cleaning and


Sanitation....................................
Validation of Cleaning and
Sanitation Procedures.................
Production .......................................
Component Preparation ..............
Processing ................................
Labelling ....................................
Release of Products...................

- ix -

192
193
193
193
193
193
194

2006 - Edition