TS-qualification-storage-areas-final-sign-off-a.pdf

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WHO Vaccine

Qualification oftemperature-controlled

storage areasTechnical supplement to

WHO Technical Report Series, No. 961, 2011

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

temperaturesensitive 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;

: @.).

T

H O , ,

, . D

.

T

H O . E

, .

A H O

. H, ,

. T . I

H O . T

.


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T S: R 1

Acknowledgments

T J B MBA , I I.


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Contents

A ................................................................................................................................ 1

C ................................................................................................................................................... 2

A ........................................................................................................................................ 4

................................................................................................................................................... 5

1. .................................................................................................................................. 7

1.1 R ...................................................................................................................................... 7

1.2 O.............................................................................................................................................. 8

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

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

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

2.2 I ......................................................................................................... 9

2.2.1

............................................... 10

2.2.2 ................................................................................................................ 10

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

2.3 Q .................................................................................................................. 11

2.3.1 ............................................................................ 11

2.3.2 .................................................................................................................... 12

2.3.3 .............................................................................................................. 12

2.3.4 ......................................................................................................................... 12

2.3.5 ................................................................................................................................... 12

2.3.6 ............................................................................................................................................. 12

2.3.7 ...................................................................................................... 13

2.3.8 ................................................................................................................................ 13

2.4 I .............................................................................................................. 13

2.4.1 ................................................................................................... 14

2.4.2 , ............................................. 14

2.4.3 .................................................................... 16

2.4.4 .......................................................................................... 17

2.4.5 ........................................................................................................................ 18

2.4.6 ...................................................................................................... 18

2.4.7 ......... 19

2.4.8 ........................................................................................................................ 19

2.5 O .............................................................................................................. 19

2.5.1 , ............................................. 20


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2.5.2 ...................................................................................... 20

2.5.3 .................................................................................................. 21

2.5.4 ........................................................................................................................................ 21

2.5.5 ............................................................................................................................................. 21

2.5.6

.................................................................................................... 22

2.5.7 ............................................................................................................................... 23

2.5.8 ...................................................................................................................... 24

2.6 P ........................................................................................................... 24

2.6.1 , ............................................. 25

2.6.2 ......................................................................................................... 25

2.6.3 ............................................................................. 25

2.6.4 ....................................................................................................................... 26

2.7 S ............................................................. 26

............................................................................................................................................ 28

.................................................................................................................................. 29


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Abbreviations

CAPA C P A ()

EDLM E D L M

IATA I A T A

IQ I Q

OQ O Q

PDA P D A

PQ P Q

SLA S L A

SMS S M S

SOP Standard Operating Procedure

TTSPP Time and Temperature-Sensitive Pharmaceutical Product

PS P S


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Glossary

A : E

.

C: A ,

(, , .).

C, :A

.

C, :A

.

C:A , ,

, .

D:F IQ: A

( ) . F OQ: A

, , , .

():T

.

:M .

():D

, ,

.1

:S

, ,

, ,

.

():D

, ,

.2

: A

,

,

,

, . I ,

, 3.

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

E, 2007.23D HO/QAS/08.252 R 1 S 2009.

.


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T S: R 6

: D

4.

: A

, QA

. T

QA .

: T

/

.

: A ( , , .),

( , , , .)

.

:P

.

(): A ,

. S

.

:A TTSPP

() / . T

;

, .

:I

.

(): A

,

/ ,

.

:D ,

, ,

.5

4D PDA T R N. 39, 2007.5PDA T R N. 39: :

, 2007.


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T S: R 7

1. Introduction

T

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

6. I

: (IQ), (OQ) (PQ). R T

S:

.

.

.

?

I T S,

. T

. E .

1 ( ): E

(RS).T .

RS ;

RS

.

1 ( ):E

7

. T .

2: E

. T .

3: C

, ,

. T

.

1.1 Requirements

E

TTSPP. A , :

E , ,

,

;

6://..///18683/18683.7T .


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T S: R 8

D, ,

() TTSPP ,

;

D TTSPP (

, );

D ,

;

D

.

F

, . T

,

.

1.2 Objectives

T T S TTSPP

. T

G S P

. T I Q (IQ); O Q (OQ),

P Q (PQ).

1.3 Target readership

T , , ,

3PL TTSPP. T

, ,

Q A (QA) M O M.


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T S: R 9

2. Guidance

T

, ,

.

2.1 Associated materials and equipmentA

(EDLM) . I ,

. T

EDLM :

B

;

P ;

H

(.. 30C +60C).

H

15 ;

H NIST 3

0.5C .

R

;

D

(.. FDA 21 CFR 11).

2.2 Introduction to qualification

Q ,

.

.

A : I

Q (IQ), O Q (OQ), P Q (PQ).

. :T (IQ)

.

. :A (OQ)

IQ

. A , OQ

.

. :F OQ, (PQ)

. T PQ


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T S: R 10

,

. I OQ, PQ

.

2.2.1 Qualification applied to temperature-controlled storage

Q

,

.

I , TTSPP

(..: 28C, 1525C). T :

A , ,

, , , .

A . T

,

. R T S:

.

P ( ). T

. R T S:

.

A ,

TTSPP .

A IQ, OQ PQ

. I IQ, OQ PQ

,

. H

.

2.2.2 Installation qualificationT IQ . I

. T

.

S, IQ :

. I

. E ;

. E (.. );

. E (SOP)

;

. E .


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T S: R 11

2.2.3 Operational and performance qualificationO IQ , OQ PQ

. T

,

.

. I :

C ;

A ;

A

8;

P .

,

. T

:

T .

T .

2.3 Qualification protocols

P,

.

T ,

IQ, OQ PQ

. E

. H ;

;

.

T :

. A .

. A .

. D .

. S .

. K .

. P.

. Q .

2.3.1 Approval page and change control history

I . T

:

8S T S: .


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T S: R 12

A D

A :

R :

R :

O :

N D D R

1 O

2

3

4

5

I ,

.

2.3.2 Acronyms and glossary

D .

2.3.3 Description and rationale

D

.

2.3.4 Scope and objectives

C .

2.3.5 Key parameters

D .

2.3.6 Procedures

T

, :

. : B ;

. : N , ;

. : C .

S ;

. : D ;

. : I .

A IQ, OQ PQ 2.4 2.7 .


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2.3.7 Qualification report template

T . T

,

:

. :D .

. :O . I .

. :S

. L ;

.

. : A :

R (

). I , .

K ,

.

D , C P A (CAPA) ,

.

C EDLM .

C

.

L , .

A , ,

. T

, .

2.3.8 Approval process

I , IQ/OQ/PQ

()

.

I , IQ/OQ/PQ

.

2.4 Installation qualificationT

, , , ,

. T

. T

.

O ,

. P :


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T S: R 14

C

.

C .

C .

C

.

I, .

I, ,

, , .

C

.

2.4.1 Identifying critical components

A IQ,

.

, : T

( ) ;

30 9.

: T , ,

, .

C , , , . F

,

10. A

, , .

I , . C

. C IQ .

2.4.2 Checking installed systems, sub-systems and components

T 1

. T .

9S T S: .10S T S:

.


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T S: R 15

1 E

: SOTH AREHOSE

: C #1

/: R #1

: I: T:

/: IQ : RF01

D: A

M: ABC ABC P

M: TT50 TT40 F

S : N TT401310025 F

I ID : CR1/RF01 CR1/RF01 P

D :

E DE/001

: AG D: 27 Oct 2013

C : JB D: 5 Nov 2013

F , , IQ

( ), (

) ( ).

. : T , ,

. T

T 2 4. P IQ

.

. I , / ()

/ ()

. K .

. :

. T ,

. I T 1 , ,

.

. : C

. I T 1 ,

, . H,

, .


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T S: R 16

. : ,

. E

. I

, A 1).

. : T

.

,

.

2.4.3 Checking electrical systems and requirements

B ,

. T 2

. T 3

.

2

E :

: SOTH AREHOSE

: E

/: 3 #1

: I: T

/: IQ : ELEC01

A

M (): 415 415 P

C (H): 50H 50H P

A (A): 100 A 100 A P

P: 3 3 P

: AG D: 27 Oct 2013

C : JB D: 5 Nov 2013

O ,

. T

T 1 .


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3 E :

E :

: SOTH AREHOSE

: E

/: 3 A

: I T:

/: IQ : ELEC05

E A

B /

P A P A

P

C / N RF1 P

C () 315 315 P

C (A) 30 A 20 A F

C 3 3 P

E ? R N

P

I ? R N

P

I

?

R N F

G? R N P

S /

?N N P

I

?R N P

: AG D: 27 Oct 2013

C : JB D: 5 Nov 2013

T

.

2.4.4 Checking environmental conditions

C

, , . R

IQ T 4.


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4 E ,

E

: SOTH AREHOSE

: C #1

/: A

: I: T:

/:IQ : EN01

EN02

A

C: A F F

F: N N P

: N RF #1 F

T : S S P

H : N N P

T : 3 3 P

H : N N P

T (C): +2C +8C

+5.5C ( 1)

+6.1C ( 2)

+4.9C ( 3)

P

H (% RH): 60% 75% 70% P

: AG D: 27 Oct 2013

C : JB D: 5 Nov 2013

2.4.5 Checking spare parts

I , IQ

. T

2.4.1.

2.4.6 Checking auxiliary equipment

T , IQ . A

. T IQ . T

,

.


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2.4.7 Checking information needed for the preventive maintenance programme

A (PMP)

. T IQ :

. I ?

. A

?

. I , ?

. I , ?

A ,

IQ . T 5

.

5 E

E

ID

E

TS OI MI RS R R

TS = T MI = M

OI = O RS = R

2.4.8 Writing the IQ report

A IQ ,

2.3.11. P :

M IQ ,

.

R

. M

IQ .

S

.

T IQ

.

L , .

2.5 Operational qualification

D

IQ .


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T S: R 20

T

. A OQ

, (PQ) ,

. O OQ/PQ ,

.

A OQ :

C

.

T

. C .

I ,

, SMS

. R .

C .

S T S: . E (SOP) ,

SOP

.


A IQ 2.4.2, OQ

. A

,

.

2.5.2 Calibration of controllers and sensors

A

. T OQ

. C .

E ID,

.

T :

C

.

E .

I , :

A , .

A .

A .


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T S: R 21

A

.

2.5.3 Standard operating procedures

T SOP

, . T

:

C SOP .

C

.

C , SOP.

T :

A SOP .

A SOP .

T , SOP,

..

2.5.4 Control panel

T ,

. T

.

T .

2.5.5 Alarm tests

T

. F ,

. I

.

F , . C

. A

,

(SS), SMS

.

O ,

. A T 6. M

.


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T S: R 22

6 A

A

C D

D

H A .

L A .

H :

L :

C : D:

2.5.6 Temperature mapping - empty

T

. T 24

(EDLM). T 7

.

7 :

D

ID

M. .

R

(C)

M .

R

(C)

M

.

(C)

?

NI D

DL001

DL002

DL003

DL004

DL005

DL006

DL007

DL

M (/):

M (/):

C : D:

:T T S:

. H,


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T S: R 23

,

. T 7 A 1 11.

2.5.7 Power failure test

T

. T :

T

.

H

.

T . F

, 12

. H,

; ,

.

P :

. :I

,

.

P

.

B ,

TTSPP . F

. T 8

.

11T . H, , .12I , . F HO , . S HO PQS :

://..////


25/31

T S: R 24

8

D

ID

T

(:)

T

(:)

I D

DL001

DL002

DL003

DL004

DL005

DL006

DL007

DL008

DL009

DL

P (:):

P (:):

C : D:

2.5.8 Writing the OQ report

A OQ ,

2.3.11. P :

M OQ ,

.

R

. M

OQ .

T OQ

.

S

.

L , .

2.6 Performance qualification

D

OQ .

T

.


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T S: R 25

P

IQ OQ . A , OQ/PQ

,

.

A PQ :

C .

C

. R . S T S:

.

T

.


A IQ 2.4.2 OQ 2.5.1,

PQ

.

A ,

.

2.6.2 Temperature mapping full

T OQ 2.5.6 ,

TTSPP. T EDLM

PQ OQ .

2.6.3 Temperature recovery after door opening

T

. T

:

T EDLM OQ PQ

.

T

. I ,

. I

, ,

, .

T EDLM

(..

2C 8C) 30 ()

. T 9 .


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T S: R 26

9 D

D

ID

T

()

C?

N I D

DL001

DL002

DL003

DL004

DL005

DL006

DL007

DL

D() (:):

D() (:):

C : D:

2.6.4 Writing the PQ report

A PQ ,

2.3.11. P :

M PQ ,

.

R

. M

PQ .

T PQ

.

S

.

L , .

T

PQ .

2.7 Specific requirements for small-scale equipment

C TTSPP

. T


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13, 14,

. C

1015 1,000

.

,

. H,

:

; , .

C IQ/OQ/PQ ,

,

. I ,

; . I ,

EDLM

. D TTSPP

.

13D HO , .14S HO PQS :

://..////


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References

C, P A. :

. I P, 1998.

H C (HPFB I). G 0001,

(), 2009 , 2.

H C (HPFB I). G 0069,

. O 17, 2005.

S P: C 1079: & .

S F & D A (FDA). 21 210.

S F & D A (FDA). 21 211.

S F & D A (FDA). 21 820.

HO T S.

.

HO T S.

.

HO T S. .


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Revision history

D C R A


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Annex 1 Deviation and corrective action report form

:

DEA DEC

D : D:

AC AEE ACA

D

?

N

D : D:

AAE CECE AC

D : D:

CECE AC AA

N S D

AAE C E DEA E

D ?

(A )

N

N

C ?

N

N S D

Documents

TS-qualification-storage-areas-final-sign-off-a.pdf