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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 WHO–TRS 902/2002, WHO – TRS 908/2003, WHO–TRS 929/2005, WHO– TRS 937/2006, Guide to GMP for Medicinal Products PIC/S 2006 and other International GMP Codes.
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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
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TIM REVISI BUKU PEDOMAN CPOB EDISI 2006 Pengarah
GMP REVISION TEAM FOR THE 2006 EDITION
: 1. Kepala Badan POM
Advisor
2. DeputiBidang Pengawasan Produk Terapetik dan NAPZA
Ketua
: Direktur Pengawasan Produksi Produk Terapetik dan PKRT.
Chairman
: 1. Head of National Agency of Drug and Food Control 2. Deputy of Therapeutic Products, Narcotics, Psychotropics and Addictive Substances Control : Director for Control of Production of Therapeutic Products and Household Products
Anggota Members 1. Amin Sjaugi, Drs. 2. Berni Somalinggi, Dra. 3. Daniel Santoso, Dr. 4. Elis Sukmawati, Dra. 5. Herny Prasetya, Dra. 6. Kustantinah, Dra. 7. Lina Astuti, Dra, M.Med.Sc. 8. Mahendra, Drs. 9. M. Sumarno, Drs. 10. Mudi Yunita Bukit, Dra. 11. Oenggoel Pribudhi, Drs. 12. Pawitra Kresno, Dra. 13. Ratna Sosialin, Dra. 14. Retno Utami, Dra. 15. Rudy F. B. Mantik, Drs. 16. Rumondang Simanjuntak, Dra. 17. Sumaria Sudian, Dra. 18. Tanusoma Widjaja, Drs. 19. Togi Hutadjulu, Dra., MHA 20. Uluan Sitorus. Dr. 21. V. Surjana, Drs. 23. Dra. Yuli Hastini
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DAFTAR
ISI
TABLE OF CONTENT Halaman
Page
PENGANTAR ...................................
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P R E F A C E ........................................
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DAFTAR ISI ......................................
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TABLE OF CONTENT ...........................
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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.........................................
5 7 9 11 11 11 11 12 15
BAB 3 - BANGUNAN DAN FASILITAS.......................... Prinsip............................................. Umum............................................. Area Penimbangan......................... Area Produksi ................................. Area Penyimpanan ......................... Area Pengawasan Mutu ................. Sarana Pendukung.........................
17 17 17 19 19 22 24 25
BAB 4 - PERALATAN ........................ Prinsip ........................................... Desain dan Konstruksi.................... Pemasangan dan Penempatan ...... Perawatan .....................................
26 26 26 28 28
BAB 5 - SANITASI DAN HIGIENE
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CHAPTER 1 - QUALITY MANAGEMENT Principle ............................................ Quality Assurance ............................ Good Manufacturing Practices for Pharmaceutical Products (GMP) ...... Quality Control .................................. Product Quality Review ....................
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CHAPTER 2 - PERSONNEL ................. Principle ............................................ General ............................................. Key Personnel .................................. Organization, Qualification and Responsibilities ................................. Training .............................................
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CHAPTER 3 - PREMISES ....................
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Principle ............................................ General ............................................. Weighing Areas ................................. Production Areas .............................. Storage Areas ................................... Quality Control Areas ........................ Ancillary Areas ..................................
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CHAPTER 4 - EQUIPMENT................... 26 Principle ............................................ 26 Design and Construction ................... 26 Installation and Location.................... 28 Maintenance ...................................... 28
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CHAPTER 5 - SANITATION AND HYGIENE ...................... Principle ............................................ Personnel Hygiene ............................ Premises Sanitation........................... Equipment Cleaning and Sanitation ..
Prinsip............................................. 30 Higiene Perorangan........................ 30 Sanitasi Bangunan dan Fasilitas .... 32 Pembersihan dan Sanitasi Peralatan. 34
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Validasi Prosedur Pembersihan dan Sanitasi ...................................
Table of Content
Validation of Cleaning and Sanitation Procedures ........................................ 35
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BAB 6 - P R O D U K S I .................. 36 Prinsip............................................. 36 Umum............................................. 36 Bahan Awal ................................... 38 Validasi Proses............................... 41 Pencegahan Pencemaran Silang ............................................. 42 Sistem Penomoran Bets/lot ............ 43 Penimbangan dan Penyerahan ...... 44 Pengembalian................................. 45 Pengolahan .................................... 46 Bahan dan Produk Kering............... 47 Pencampuran dan Granulasi .. 48 Pencetakan Tablet................... 49 Penyalutan .............................. 49 Pengisian Kapsul Keras .......... 50 Penandaan Tablet Salut dan Kapsul .............................. 50 Cairan, Krim dan Salep (non steril) ..................................... 50 Bahan Pengemas ........................... 52 Kegiatan Pengemasan ................... 53 Pra-kodifikasi Bahan Pengemas ............................... 53 Kesiapan Jalur......................... 54 Praktik Pengemasan ............... 54 Penyelesaian Kegiatan Pengemasan............................. 57 Pengawasan-Selama-Proses........... 58 Bahan dan Produk yang Ditolak, Dipulihkan dan Dikembalikan ......... 59 Karantina dan Penyerahan Produk Jadi ....................................... 61 Catatan Pengendalian Pengiriman Obat .................................................. 63 Penyimpanan Bahan Awal, Bahan Pengemas, Produk Antara, Produk Ruahan dan Produk Jadi ................... 63 Penyimpanan Bahan Awal dan Bahan Pengemas................ 65 Penyimpanan Produk Antara, Produk Ruahan dan Poduk Jadi.. 66 Pengiriman dan Pengangkutan ......... 66
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 ...........
BAB 7 - PENGAWASAN MUTU..... Prinsip ............................................. Umum.............................................. Cara Berlaboratorium Pengawasan Mutu Yang Baik...............................
CHAPTER 7- QUALITY CONTROL ..... 68 Principle ............................................ 68 General ............................................. 68 Good Quality Control Laboratory Practices ........................................... 70
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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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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 ............................................ 75 Documentation ................................. 76 Sampling ........................................... 76 Starting Materials .......................... 77 Packaging Materials...................... 78 Sampling Operations .................... 78 Test Requirements ...................... 80 Environment Control ..................... 81 In-process Control......................... 82 Retesting of Approved Materials... 82
75 76 76 77 78 78 80 81 82 82 82
Reprocessing................................ 82 Quality Control Evaluation on Production Procedures ................. 83 Stability Study ............................... 83
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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
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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..............
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Spesifikasi Bahan Pengemas ....
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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..........................
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Spesifikasi Produk Jadi ..............
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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
Specifications for Finished Products ....................................... 100 Production Documents.................. 100 Master Production Document ....... 101 Master Processing Procedure....... 101 Master Packaging Procedure........ 102 Batch Processing Record ............. 103 Batch Packaging Record .............. 104 Procedures and Records .............. 106 Receipt ................................ 106 Sampling.............................. 106 Testing................................. 107 Others.................................. 107
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 ............ 113 Principle .......................................... 113 Planning For Validation.................... 113 Documentation ............................... 114 Qualification ..................................... 114 Design Qualification ............... 114 Installation Qualification ......... 115 Operational Qualification........ 115 Performance Qualification...... 116 Qualification of Established (in-use) Facilities, Systems and Equipment....................... 116 Process Validation........................... 116 General..................................... 116 Prospective Validation .............. 117
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109 109 109 110 110 111
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………………….
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ANEKS ANEKS 1 - PEMBUATAN PRODUK STERIL..............................
NNEXES NNEX 1 - MANUFACTURE OF STERILE PHARMACEUTICAL PRODUCTS ..................... 125 Principle .......................................... 125 General ........................................... 125 Isolator Technology ........................ 130 Blow/Fill/Seal Technology ............... 131
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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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 NNEX 2 - MANUFACTURE OF BIOLOGICAL PRODUCTS.. 157 Scope ............................................. 157 Principle .......................................... 157 Personnel ....................................... 158 Premises and Equipment ................ 159
157 157 157 158 159
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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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 .....
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167 167 167
NNEX 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 Equipment…………………………168 Documentation ………………………. 170 Production ……………………………. 171 Bulk Production…………………. 171 Filling and Labeling..................... 172 Quality Control ................................ 176 Storage and Release ...................... 177
ANEKS 4 - PEMBUATAN INHALASI DOSIS TERUKUR BERTEKANAN (AEROSOL)... 179
ANNEX 4 - MANUFACTURE OF PRESSURIZED METERED DOSE INHALER (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
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Equipment Cleaning and Sanitation.................................... Validation of Cleaning and Sanitation Procedures................. Production ....................................... Component Preparation .............. Processing ................................ Labelling .................................... Release of Products...................
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