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3/26/2012 11:53:35 AM

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20011123

(I)

Clostridium Sordellii

4

2

(II)

(CDC)

Clostridium Infections Associated with M l k l t l Ti All ftMusculoskeletal-Tissue Allografts

N Engl J Med 2004; 350:2564-2571

5

FDA 2002/3

FDA+CDC

CDC 2002/7 54

2002/8 7913

6

3

CDC

CDC findings

+

7

1980dura mater (C t f ld J k b Di CJD)

(I)

(Creutzfeld-Jakob DiseaseCJD)

19927 1990

CJD

8

4

1999

(II)

2002 C 6

9

Take home message (I)

CDC2002 3Morbidity and Mortality Weekly Report (MMWP)(aseptic)(sterile) (sterile)

10

5

42 USC 264 - Regulations to control i bl di

(I)

communicable diseasesSection 361 (Sec. 361) of the Public Health Service Act (PHS Act) [42 USC 264].FDA 1993/12

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12/14/1993 provisions of the interim l fi l l 21 CFR 1270

(II)

rule final rule 21 CFR 1270 (1998/1/26 )FDA PHS Act Section 36121 CFR 1270, F d l F d D dFederal Food, Drug, and Cosmetic Act (FD&C Act)

13

6

1997 FDA:

(III)

;

(cGTP)

21 CFR 1271 (2004/1/21 )14

21 CFR part 1270: human tissue intended for transplantation

(IV)

transplantation

FDAFDAFDA

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7

Subpart A--General Provisions

(IV-1) 21 CFR 1270

Subpart B--Donor Screening and TestingSubpart C--Procedures and RecordsSubpart D--Inspection of Tissue Establishments

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21 CFR part 1271: current good tissue ti f f t f h

(V)

practice for manufacturers of human cellular and tissue-based products cGTPHCT/Ps

17

8

Subpart A--General ProvisionsS b t B P d f R i t ti d

(V-1) 21 CFR 1271

Subpart B--Procedures for Registration and Listing Subpart C--Donor Eligibility Subpart D--Current Good Tissue Practice Subpart E Additional Requirements forSubpart E--Additional Requirements for Establishments Described in 1271.10 Subpart F--Inspection and Enforcement of Establishments Described in 1271.10

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AATB

1976

19861993 6th Standards1996 7thS

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Standards 21 108200 510th Standards 142200812th Standards 113()+ guidance2012/213th

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21 CFR 1270 & 1271

Regulations vs. Standards (I)

AATB standardsfunctional components of a tissue bank director, medical director, technical t ff lit staff, quality assurance program

qualifications & responsibilities

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Sec. 1271.260 Storage. ( )C t l f t Y t

Regulations vs. Standards (II)

(a)Control of storage areas. You must control your storage areas and stock rooms to prevent:(1) Mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents, and (2) An HCT/P from being improperly made available for distribution.(b)Temperature. You must store HCT/Ps at an appropriate temperature.21

10

Sec. 1271.260 Storage.

Regulations vs. Standards (III)

(c)Expiration date . Where appropriate, you must assign an expiration date to each HCT/P based on the following factors: (1) HCT/P type; (2) Processing, including the method of preservation; (3) Storage conditions; and (4) Packaging.(d)Corrective action(e)Acceptable temperature limits .

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AATB standards

Regulations vs. Standards (IV)

E 4.100 storage temperature (

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E4.300 Expiration Date/Storage period

Regulations vs. Standards (IV-1)

E4.320 :5: 5

: 5

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EU

1994(R d ti N R(94)1)(Recommendation No. R(94)1)2004(Directive)2004/23/EC 2005(European

i i H lth & C

25

commission Health & Consumer Protection Directorate-General)

12

Derivative 2006/86/EC

Unless otherwise specified in point 4, where tissues or cells are exposed to thetissues or cells are exposed to the environment during processing, without a subsequent microbial inactivation process, an air quality with particle counts and microbial colony counts equivalent to those f G f

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of Grade A as defined in the current European Guide to Good Manufacturing Practice (GMP)

Grade Aclass 100 ISO 5

Remark(I)

Derivative 2006/86/EC2003/94/ECGMPD(Class 10ISO 8)

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13

2006/86/EC(microbial inactivation)

Remark(II)

(microbial inactivation)A A AAA

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EATB (I)

The first European Conference on Ti B ki i 1991 ETissue Banking in 1991 European Association of Tissue Banks (EATB)The Association shall promote cooperation, research and d l t i th f Ti

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developments in the area of Tissue Banking and related sciences in Europe.

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EATB(II)

The aims of the EATB are:- international coordination;- international standardization;- exchange of experience;- cooperation

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cooperationCommon Standards for Tissues and Cells Banking, version 2003

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15

7

2

56

198810(Asia Pacific Association of(Asia Pacific Association of Surgical Tissue BanksAPASTBwww.apastb.net )APASTB standards for tissue banking

57

16

(I)

GMPGMP4

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200(cornea)20(sclera)10

(II)

(www.eplanetventures.com/en/news/releases/pr_031408_1.html)Korea Bone Bank Inc.(1997)www kbbcom co kr

59

)www.kbbcom.co.kr

17

Korea Bone Bank

(III)

Dr. Nather 1988

NUS 1992960(deep-frozen long bones)(lyophilized)

61

1994NUS9

18

(III-1)

National University Hospital Tissue Bank protocol follows guidelinesBank protocol follows guidelines recommended by the American Association of Tissue Banks and the European Association of Tissue Banks using donor selection criteria

62

using donor selection criteria Femoral Head Banking: NUH Tissue Bank Experience ORTHOPEDICS April 2007;30(4):308.

(III-1)

http://www.nhcs.com.sg/patientcare/clinicalspecialtiesservices/cardiothoracicsurgery/NCHB/Pages/Home.aspx

63

19

Take home message (II)

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TW &

67

20

14

68

18-1

69

21

98.02.02

2

70

www.fda.gov.tw/people_laws_list.aspx?classifysn=88 ?

71

22

72

73

23

74

14

76

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1st 120K NT 2nd 80K NT

1st 120K NT, 2nd 80K NT

1st 80K NT, 2nd 50K NT 5K NT 50K NT: ,,

77

Remark:

120K NT 150K 80K 80K

20~100 200~1000

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TFDA

or

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GTP(I)

()

AATB standards: training, competency, continuing education, training records

79

GTP(II)

However, class 100 l 10Kclass 10K

80

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EXP:

81

USA EU APASTB TW

PHS directives

21 CFR 1270,1271

82

AATB standards

EATB standards

APASTB standards

27

199711 26

() ()

83

199711 26

84

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Take home message (I)

CDC2002 3Morbidity and Mortality Weekly Report (MMWP)(aseptic)(sterile) (sterile)

85

Take home message (II)

86

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tissue bank or cell bank

Take home message (III)

:3:

2 2:

87

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