TS Mapping Storage Areas WHO

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WHO Vaccine

Temperature mapping ofstorage areas

Technical supplement to

WHO Technical Report Series, No. 961, 2011

Annex 9: Model guidance for the storage and transport of time and

temperature–sensitive pharmaceutical products

January 2014

2014

HO P, H O, 20 A A, 1211 G 27, S (.: +41 22 791 3264; : +41 22

791 4857; : @. ). R HO

HO P, (: +41 22 791 4806;

: @. ).

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H O , ,

, . D

.

T

H O . E , .

A H O

. H, , . T . I

H O . T

.


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T S: T 1

Acknowledgments

T J B, P & C E O, I

I.


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Contents

................................................................................................................................ 1

................................................................................................................................................... 2

........................................................................................................................................ 3

................................................................................................................................................... 4

1. .................................................................................................................................. 6

1.1 R ...................................................................................................................................... 6

1.2 O.............................................................................................................................................. 7

1.3 T .............................................................................................................................. 8

2. ......................................................................................................................................... 9

2.1 A ........................................................................................ 9

2.2 T ................................................................................................................... 10

2.2.1

: ........................................................................... 10

2.2.2 :................................................................................................................... 11

2.2.3 .............................................................................................................. 11

2.2.4 : ....................................................................................................................................................... 11

2.2.5 : .............................................................................................................................................. 11

2.2.6 ......................................................................................................................................... 12

2.2.7 ............................................................................................................... 15

2.3 C ............................................................................................ 16

2.4 A ................................................... 16

2.4.1 ......................................................................................................................... 16

2.4.2 .................................. 16

2.4.3 ........................................................................................................................... 17

2.4.4 .................................................. 18

2.4.5 ................................................................................................................................... 19

2.5 I .................................................... 19

R.................................................................................................................................................... 20

1 .............................................................................................................. 21

A1.1 T : ........................................................ 21

A1.2 T : ........................................................................... 22

A1.3 T : ........................................................................... 23

.................................................................................................................................. 24


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Abbreviations

3PL T P L ()

CAPA C P A ()

GMP G M P

IQ I Q

NIST N I S T (S)

SLA S L A

SOP S O P

EDLM E D L M

TTSPP T TS P P


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Glossary

: A ,

(, , .).

: A , ,

, .

: A ,

, , .

(): T

.

: A ,

, (C, % RH, A, .) .

:

.

: M .

: D

.

(): D

, ,

.1

(): D

, ,

.2

: A

,

,

,

, . I ,

, 3.

: T

/

.

: A ( , , .),

( , , , .)

1 PDA T R N. 39: G T C M P:M Q TS M P T

E, 2007.2 3 D HO/QAS/08.252 R 1 S 2009.

.


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T S: T 5

.

(): A

, ,

. I ,

. T SLA

, 4.

(): A

,

. S

.

: T TTSPP ,

, .

:I

.

(): A

,

/ ,

.

: D ,

, ,

.5

4 D IATA, C 17, 9 E, J 2009. 5 PDA T R N. 39: :

, 2007.


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1. Introduction

T

S 4.7 HO T R S N. 961, 2011, A 9:

6. T

.

T

, . I

. G ,

TTSPP,

7.

T T S :

• .

• .

• .

• .

1.1 Requirements

A

,

. , TTSPP .

T :

• D ,

;

• D TTSPP (

, );

• D

.

S ,

. I

. E

,

, . F

/

.A

, .

6 ://..///18683/18683. 7 S : ://..////


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1.2 Objectives

T T S

. T

TTSPP

.


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1.3 Target readership

T , , ,

3PL TTSPP. T

,

, Q A (QA) M O M.


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2. Guidance

A

. T

, , ,

. I . T

: 25C 10C, 2C 8C, 15C 25C, .T

.

A

. T

TTSPP

(). M

;

,

8 .

A , :

. P .

. C .

. P .

. I

. A

.

2.1 Associated materials and equipment

A E D L M

(EDLM) . I ,

. T EDLM :

• B

;

• P ;

• H

(.. 30C +60C)

• H ,

15

;

• H NIST 3

0.5C .

• A

;

8 H . I

.


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T S: T 10

• H

(21 CFR 11)9,10,11.

2.2 The mapping protocol

A ,

. A

.

,

.

T :

. A .

. A .

. D .

. S

. O.

. M. M .

. A ,

T .

2.2.1 Approval page and change control h istory:

I . T

:

A :

R :

R :

O :

9 S P: C 1079: & .10 S P: C 1118: , .11 S F & D A (FDA): 21 11.


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N D D R

1 O

2

3

4

5

I ,

.

2.2.2 Acronyms and glossary:

D .

2.2.3 Description and rationaleD

.

2.2.4 Scope:

C . T

()

, . P,

. I

,

. T

.T

. T

.

2.2.5 Objectives:

C , :

• M . T

, , , ,

,

.

• M ,

, .

• D

, ,

.

• I

.


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T S: T 12

• R TTSPS . T

()

.

• I , ,

. I , (

).

• M

.

2.2.6 Methodology

T .

STEP 1 EDLM: S EDLM . C

. A S 1.4, NIST 3

( ), 0.5C

.

. S EDLM

;

.

C

. I

, ,

.

T , . P

.

STEP 2 : I . R

. E

.

STEP 3 : C () . T

:

• L, .

• D , , ,

. T

EDLM, .

• T ,

/ .

• T

.


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STEP 4 : G

, TTSP ,

: +2C

+8C +15C +25C. H,

. T

,

.

STEP 5 EDLM :

EDLM. T

EDLM :

: EDLM

, EDML 510 .

T :

• T (.., ).

• T .

• . T EDLM

TTSP . F ,

EDLM .

• O EDLM.

: A , EDLM :

• I 3.6 , EDLM

(.. EDLM , 1.2

EDLM 3.0 .

• I 3.6 , EDLM

, . F , , EDML 1.8

, 3.6 5.4 .

G ID. I

F 1 2. F 1

. F 2 .


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T S: T 14

1

2

STEP 6 EDLM : R EDLM

1.1. A

1.2.

STEP 7 EDLM: L EDLM ID,

. E

( 1.1). R

. P ,

5 15

. S . T ;

. M

.


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STEP 8 EDLM : F EDLM . M

.

P

.

STEP 9 : T .

T 10

. F

(..

), 24 72 ,

. I

; . T

12.

A , EDLM

.

STEP 10 : D EDLM

S 2.4.

2.2.7 Mapping report template

T . T

:

. : .

. :

, ( ).

. :

.

R .

. : T :

− T , EDLM .

− T ,

1.

− S EDLM

.

− R .

− K ,

.

− D , C P A (CAPA) ,

.

− C EDLM .

12 D . T

.


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2.3 Conducting the mapping exercise

C . E

EDLM. A , ,

, .

2.4 Analyzing the data and preparing the mapping report

T S 2.2.7. T

.

2.4.1 Preliminary analysis

A

. C . T

:

• T

( ).

• T ,

.

T :

• EDLM.

• T ,

, EDLM.

• T ,

2.4.2 Minimum and maximum temperatures and hot and cold spots

A . F ,

.

M

;

. E

. 1.3

, S 2.4.4.

A ()

, ()

(.. +15C +17.5C

+15C +25C).

A ()

, ()

(.. +23C +25C

+15C +25C).


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T

. H

.

2.4.3 Mean temperatures

E (MKT)13

. T

(.. ,

)

.

T MKT

EDLM . T

EDLM . T

,

.

I F 1, (EDLM1 EDLM2). T EDLM2

,

.

D ,

;

.

13 S: S, R. . () , . P O, M/J

2009.


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T S: T 18

3

2.4.4 Interpreting the results and making recommendationsT ,

:

• D ,

EDLM .

•

( ).


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T S: T 19

• A

14.

• L . F ,

.

• A , ,

.

• B

,

, .

• B

,

()

.

2.4.5 Report auditing

T , , ,

. T

,

. I

, .

2.5 Implementing the mapping report recommendations

T

. A

, :

• A TTSPP

. I . F,

.

• A TTSPP

.

• R /

.

• A /

.

•

.

• A

TTSPP.

14 T : ; / . T

.


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References

• S P: C 1079: & .

• S P: C 1118: ,

.

• H C (HPFB I): G 0069: . O 17, 2005.

• S, R. . () ,

. P

O, M/J 2009.

• S F & D A (FDA): 21 11.

• HO T S.

.

• HO T S. .

• HO T S. .

• HO T S.

.


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Annex 1 – Test data sheets

T

.

A1.1 Test data sheet: temperature data logger locations

D

ID

D

ID

M

()D / C

DL001 1 0.3

DL002 2 2.8

DL003 3 5.4

DL004 4 0.3

DL005 5 2.8

DL006 6 5.4

DL007 7 0.3

DL008 8 2.8

DL009 9 5.4

DL010 10 0.3

DL011 11 2.8

DL012 12 5.4

DL013 13 0.3

DL014 14 2.8

DL015 15 5.4

DL016 16 0.3

DL017 17 2.8

DL018 18 5.4

DL019 19 0.3

DL020 20 2.8

DL021 21 5.4

DL022 22 0.3

DL023 23 2.8

DL024 24 5.4


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A1.2 Test data sheet: temperature distribution

L S C

N #1 20C L

N #4 20C L


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A1.3 Test data sheet: temperature distribution

D

ID

M. .

R

(C)

M .

R

(C)

M

.

(C)

?

NI D

DL001 18.6 22.4 20.5 JB

DL002

DL003

DL004

DL005

DL006

DL007

DL008

DL009

DL010

DL011

DL012

DL013

DL014

DL015

DL016

DL017

DL018

DL019

DL020

DL021

DL022

DL023

DL024

M (/):

M (/):

: :


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Revision history

D C R A

Documents

TS Mapping Storage Areas WHO