PENGANTAR
PREFACE
Edisi 2009
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Edisi 2009
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2009 Edition
EDITOR TEAM
TIM PENYUSUN
Pengarah
Ketua
Advisor
Edisi 2009
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2009 Edition
Daftar Isi
Table of Contents
DAFTAR ISI
TABLE OF CONTENTS
Halaman
PENGANTAR ......................................
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TIM PENYUSUN .................................. iii
DAFTAR ISI ........................................ iv
PREFACE ...........................................
EDITOR TEAM ....................................
TABLE OF CONTENT ........................
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CHAPTER 2 QUALITY
MANAGEMENT .......
Principle ..........................................
Responsibilities of the Quality
Unit(s) .............................................
Responsibility for Production
Activities .........................................
Internal Audits (Self Inspection) ......
Product Quality Review ..................
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CHAPTER 3 PERSONNEL
Personnel Qualifications .................
Personal Hygiene ...........................
Consultants ....................................
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CHAPTER 5 PROCESS
EQUIPMENT ............
Design and Construction ................
Equipment Maintenance and
Cleaning .........................................
Calibration ......................................
Computerized Systems ..................
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CHAPTER 6 DOCUMENTATION
AND RECORDS ......
Documentation System and
Specifications .................................
Equipment Cleaning and Use
Record ............................................
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CHAPTER 7 MATERIALS
MANAGEMENT .......
General Controls ............................
Receipt and Quarantine .................
Sampling and Testing of Incoming
Production Materials .......................
........................................................
Storage ...........................................
Re-evaluation .................................
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CHAPTER 11 QUALITY
CONTROLS..............
General Controls ............................
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BAB 13 PENGENDALIAN
PERUBAHAN ......................
BAB 14 PENOLAKAN DAN
PENGGUNAAN KEMBALI
BAHAN ...............................
Penolakan........................................
Pengolahan Ulang ...........................
Pengerjaan Ulang ............................
Perolehan Kembali Bahan dan
Pelarut ............................................
Pengembalian..................................
BAB 15 PENANGANAN KELUHAN
DAN PENARIKAN
KEMBALI PRODUK ............
BAB 16 PABRIK (TERMASUK
LABORATORIUM)
PENERIMA KONTRAK .......
BAB 17 AGEN, PERANTARA,
PEDAGANG,
DISTRIBUTOR,
PERUSAHAAN
PENGEMASAN ULANG
DAN PERUSAHAAN
PELABELAN ULANG ........
Penerapan .......................................
Ketertelusuran BAO dan Produk
Antara yang Didistribusikan ............
Manajemen Mutu .............................
Pengemasan Ulang, Pelabelan
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CHAPTER 16 CONTRACT
MANUFACTURERS
(INCLUDING
LABORATORIES) ...
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CHAPTER 17 AGENTS,
BROKERS,
TRADERS,
DISTRIBUTORS,
REPACKERS AND
RELABELLERS .......
Applicability ....................................
Traceability of Distributed APIs and
Intermediates ..................................
Quality Management ......................
Repackaging, Relabelling and
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CHAPTER 18 SPECIFIC
GUIDANCE FOR
APIs
MANUFACTURED
BY CELL CULTURE/
FERMENTATION ....
General ..........................................
Cell Bank Maintenance and Record
Keeping ..........................................
Cell Culture/Fermentation ..............
Harvesting, Isolation and
Purification .....................................
Viral Removal/Inactivation Steps ....
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GLOSARIUM .......................................
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GLOSSARY ........................................
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