Standards for cellular therapy product services:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Bethesda, Md.
AABB
2008
|
| Ausgabe: | 3. ed. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XV, 126 S. |
| ISBN: | 9781563952739 9783805589949 |
Internformat
MARC
| LEADER | 00000nam a2200000 c 4500 | ||
|---|---|---|---|
| 001 | BV035392893 | ||
| 003 | DE-604 | ||
| 005 | 20090507 | ||
| 007 | t | ||
| 008 | 090325s2008 gw |||| 00||| eng d | ||
| 015 | |a 08,N37,0764 |2 dnb | ||
| 016 | 7 | |a 990119858 |2 DE-101 | |
| 020 | |a 9781563952739 |9 978-1-56395-273-9 | ||
| 020 | |a 9783805589949 |c Pb. : EUR 293.00 (freier Pr.), sfr 410.00 (freier Pr.) |9 978-3-8055-8994-9 | ||
| 024 | 3 | |a 9783805589949 | |
| 035 | |a (OCoLC)228114868 | ||
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| 084 | |a 610 |2 sdnb | ||
| 245 | 1 | 0 | |a Standards for cellular therapy product services |c American Assoc. of Blood Banks |
| 250 | |a 3. ed. | ||
| 264 | 1 | |a Bethesda, Md. |b AABB |c 2008 | |
| 300 | |a XV, 126 S. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Blood Banks |x standards |z United States | |
| 650 | 4 | |a Cell Transplantation |x standards |z United States | |
| 650 | 4 | |a Cellular therapy equipment industry |x Standards |z United States | |
| 650 | 4 | |a Cellular therapy equipment industry |z United States |x Quality control | |
| 650 | 4 | |a Tissue Transplantation |x standards |z United States | |
| 650 | 0 | 7 | |a Frischzellentherapie |0 (DE-588)4067560-9 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Standardisierung |0 (DE-588)4056914-7 |2 gnd |9 rswk-swf |
| 651 | 4 | |a USA | |
| 689 | 0 | 0 | |a Frischzellentherapie |0 (DE-588)4067560-9 |D s |
| 689 | 0 | 1 | |a Standardisierung |0 (DE-588)4056914-7 |D s |
| 689 | 0 | |C b |5 DE-604 | |
| 710 | 2 | |a American Association of Blood Banks |e Sonstige |0 (DE-588)1030446-0 |4 oth | |
| 856 | 4 | 2 | |m Digitalisierung UB Regensburg |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017313650&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-017313650 | ||
Datensatz im Suchindex
| _version_ | 1804138816530808832 |
|---|---|
| adam_text | TABLE
OF
CONTENTS
Preface
...............................................
v
Introduction
..........................................ix
1.
ORGANIZATION
..................................1
1.1
Structure
................................... 1
1.2
Quality
......................................2
2.
RESOURCES
.....................................5
2.1
Resources
...................................5
2.2
Human Resources
.............................5
3.
EQUIPMENT
.....................................7
3.1
Control of Equipment
..........................7
3.2
Computer Systems
............................9
4.
AGREEMENTS
..................................11
4.1
Agreement Development and Review
.............11
4.2
Obtaining Materials and Services
................15
4.3
Notification
.................................16
Reference Standard
4.1^-1^011^
Consent
..........17
5.
PROCESS CONTROL
.............................19
5.1
Process Control
..............................19
5.2
Clinical Outcomes
............................19
5.3
Design Control
..............................20
5.4
Change Control.
.............................21
5.5
Quality Control
..............................21
5.6
Materials Management
........................21
5.7
Methods and Operational Controls
...............24
xiii
Table
of Contents
5.8
Product Identification and Traceability
............26
5.9
Labels, Labeling, and Labeling Controls
...........27
5.10
Donor Eligibility
..............................
28
5.11
Medical Management and Emergency Care of
Donors
..................................32
5.12
Procurement
................................34
5.13
Procurement
Endpoints.......................36
5.14
Packaging
..................................36
5.15
Transportation
...............................37
5.16
Inspection and Testing
........................38
5.17
Processing
..................................40
5.18
Storage and Preservation
......................42
5.19
Final Cellular Therapy Product Release
............45
5.20
Administration
...............................49
Reference Standard
5.9.1
А
-Requirements for Labeling
of Cellular Therapy Products
.......................52
Reference Standard
5.9.1
B-Biohazard and Warning
Labels
........................................56
Reference Standard
5.9.1
С
-Requirements for Labeling
Shipping Containers
.............................59
Reference Standard
5.1
OA-General Requirements for
Eligibility of Cellular Therapy Product Donors
..........60
Reference Standard
5.1
OB-Clinical Evaluation and
Laboratory Testing of Donors
......................64
Reference Standard
5.10.7.1
А
-Requirements for
Notification of Abnormal Results
....................66
Reference Standard
5.1
S.óA-Labelingand
Packaging
Requirements Upon Shipping of Cellular Therapy
Products
......................................68
Reference Standard
5.17A-Pгocessing
Tests for HPC,
Apheresis and HPC, Marrow Products
...............69
Reference Standard
5.17B-Processiпg
Tests for HPC,
Cord Blood Products
.............................70
Reference Standard
5.17C-Processiпg
Tests for
Cellular Therapy Products Other than HPC,
Apheresis; HPC, Marrow·, and HPC, Cord Blood
.......72
xiv
Table of Contents
6.
DOCUMENTS AND RECORDS
......................73
6.1
Document Control
...........................73
6.2
Record Control
..............................74
6.3
Computer Records
...........................76
Reference Standard
6.2.1
A-Records
..................77
7.
DEVIATIONS AND NONCONFORMING
PRODUCTS OR SERVICES
.........................83
7.1
Deviations
..................................83
7.2
Control of Nonconforming Products or Services
___83
7.3
Adverse Reactions
............................85
7.4
Reporting
...................................86
8.
INTERNAL AND EXTERNAL ASSESSMENTS
............87
8.1
Quality Assessments
..........................87
8.2
Proficiency Testing
...........................87
9.
PROCESS IMPROVEMENT
.........................89
9.1
Corrective and Preventive Action Plans
...........89
10.
SAFETY AND FACILITIES
..........................91
10.1
Safety
.....................................91
10.2
Facilities and Environmental Controls
.............91
10.3
General Operational Controls
...................92
Glossary
............................................93
Crosswalk Between the Second and
Third Editions of CT Standards
..........................111
Index
.............................................117
XV
|
| any_adam_object | 1 |
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| ctrlnum | (OCoLC)228114868 (DE-599)DNB990119858 |
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| dewey-raw | 681/.761 |
| dewey-search | 681/.761 |
| dewey-sort | 3681 3761 |
| dewey-tens | 680 - Manufacture of products for specific uses |
| discipline | Handwerk und Gewerbe / Verschiedene Technologien Medizin |
| edition | 3. ed. |
| format | Book |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV035392893 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T21:34:12Z |
| institution | BVB |
| institution_GND | (DE-588)1030446-0 |
| isbn | 9781563952739 9783805589949 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-017313650 |
| oclc_num | 228114868 |
| open_access_boolean | |
| owner | DE-355 DE-BY-UBR |
| owner_facet | DE-355 DE-BY-UBR |
| physical | XV, 126 S. |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | AABB |
| record_format | marc |
| spelling | Standards for cellular therapy product services American Assoc. of Blood Banks 3. ed. Bethesda, Md. AABB 2008 XV, 126 S. txt rdacontent n rdamedia nc rdacarrier Blood Banks standards United States Cell Transplantation standards United States Cellular therapy equipment industry Standards United States Cellular therapy equipment industry United States Quality control Tissue Transplantation standards United States Frischzellentherapie (DE-588)4067560-9 gnd rswk-swf Standardisierung (DE-588)4056914-7 gnd rswk-swf USA Frischzellentherapie (DE-588)4067560-9 s Standardisierung (DE-588)4056914-7 s b DE-604 American Association of Blood Banks Sonstige (DE-588)1030446-0 oth Digitalisierung UB Regensburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017313650&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Standards for cellular therapy product services Blood Banks standards United States Cell Transplantation standards United States Cellular therapy equipment industry Standards United States Cellular therapy equipment industry United States Quality control Tissue Transplantation standards United States Frischzellentherapie (DE-588)4067560-9 gnd Standardisierung (DE-588)4056914-7 gnd |
| subject_GND | (DE-588)4067560-9 (DE-588)4056914-7 |
| title | Standards for cellular therapy product services |
| title_auth | Standards for cellular therapy product services |
| title_exact_search | Standards for cellular therapy product services |
| title_full | Standards for cellular therapy product services American Assoc. of Blood Banks |
| title_fullStr | Standards for cellular therapy product services American Assoc. of Blood Banks |
| title_full_unstemmed | Standards for cellular therapy product services American Assoc. of Blood Banks |
| title_short | Standards for cellular therapy product services |
| title_sort | standards for cellular therapy product services |
| topic | Blood Banks standards United States Cell Transplantation standards United States Cellular therapy equipment industry Standards United States Cellular therapy equipment industry United States Quality control Tissue Transplantation standards United States Frischzellentherapie (DE-588)4067560-9 gnd Standardisierung (DE-588)4056914-7 gnd |
| topic_facet | Blood Banks standards United States Cell Transplantation standards United States Cellular therapy equipment industry Standards United States Cellular therapy equipment industry United States Quality control Tissue Transplantation standards United States Frischzellentherapie Standardisierung USA |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017313650&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT americanassociationofbloodbanks standardsforcellulartherapyproductservices |