Qualification of temperature-controlled
storage areas ( summary and questions)
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
May 2015
© World Health Organization 2015
WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264;
fax: +41 22 791 4857; e-mail: ). Requests for permission to reproduce or translate WHO
publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at
the above address (fax: +41 22 791 4806; e-mail: ).
The designations employed and the presentation of the material in this publication do not imply the
expression of any opinion whatsoever on the part of the World Health Organization concerning the legal
status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers
or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full
agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are
endorsed or recommended by the World Health Organization in preference to others of a similar nature that
are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by
initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information
contained in this publication. However, the published material is being distributed without warranty of any
kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with
the reader. In no event shall the World Health Organization be liable for damages arising from its use. The
named authors alone are responsible for the views expressed in this publication.
Contents
Abbreviations 4
Acknowledgements 5
,Glossary 6
1 . Introduction 9
1.1 Requirements 10
1.2 Objectives 11
1.3 Target readership 11
2 . Guidance 12
2.1 Associated materials and equipment 12
2.2 Introduction to qualification 12
2.2.1 Qualification applied to temperature-controlled storage 13
2.2.2 Installation qualification 14
2.2.3 Operational and performance qualification 14
2.3 Qualification protocols 15
2.3.1 Approval page and change control history 15
2.3.2 Acronyms and glossary 16
2.3.3 Description and rationale 16
2.3.4 Scope and objectives 16
2.3.5 Key parameters 16
2.3.6 Procedures 16
2.3.7 Qualification report template 17
2.3.8 Approval process 18
2.4 Installation qualification 18
2.4.1 Identifying critical components 18
2.4.2 Checking installed systems, subsystems and components 19
2.4.3 Checking electrical systems and requirements 21
2.4.4 Checking environmental conditions 23
2.4.5 Checking spare parts 25
2.4.6 Checking auxiliary equipment 25
2.4.7 Checking information needed for the preventive maintenance
programme 25
2.4.8 Writing the IQ report 26
2.5 Operational qualification 26
2.5.1 Checking installed systems, subsystems and components 27
2.5.2 Calibration of controllers and sensors 27
2.5.3 Standard operating procedures 27
2.5.4 Control panel 28
2.5.5 Alarm tests 28
2.5.6 Temperature mapping – empty 29
2.5.7 Power failure test 30
2.5.8 Writing the OQ report 32
2.6 Performance qualification 32
2.6.1 Checking installed systems, subsystems and components 33
2.6.2 Temperature mapping – full 33
2.6.3 Temperature recovery after door opening 32
2.6.4 Writing the PQ report 33
2.7 Specific requirements for small-scale equipment 33
Bibliography 35
2
,Revision history 37
Annex 1
Deviation and corrective action report form 38
3
, WHO Expert Committee on Specifications for Pharmaceutical Preparations
Abbreviations
CAPA corrective and preventive action (procedures)
EDLM electronic data logging monitor
IATA International Air Transport Authority
IQ installation qualification
OQ operational qualification
PDA Parenteral Drug Association
PQ performance qualification
SMS short message service
SOP standard operating procedure
TTSPP time- and temperature-sensitive pharmaceutical product
UPS uninterrupted power supply
4
storage areas ( summary and questions)
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
May 2015
© World Health Organization 2015
WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264;
fax: +41 22 791 4857; e-mail: ). Requests for permission to reproduce or translate WHO
publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at
the above address (fax: +41 22 791 4806; e-mail: ).
The designations employed and the presentation of the material in this publication do not imply the
expression of any opinion whatsoever on the part of the World Health Organization concerning the legal
status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers
or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full
agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are
endorsed or recommended by the World Health Organization in preference to others of a similar nature that
are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by
initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information
contained in this publication. However, the published material is being distributed without warranty of any
kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with
the reader. In no event shall the World Health Organization be liable for damages arising from its use. The
named authors alone are responsible for the views expressed in this publication.
Contents
Abbreviations 4
Acknowledgements 5
,Glossary 6
1 . Introduction 9
1.1 Requirements 10
1.2 Objectives 11
1.3 Target readership 11
2 . Guidance 12
2.1 Associated materials and equipment 12
2.2 Introduction to qualification 12
2.2.1 Qualification applied to temperature-controlled storage 13
2.2.2 Installation qualification 14
2.2.3 Operational and performance qualification 14
2.3 Qualification protocols 15
2.3.1 Approval page and change control history 15
2.3.2 Acronyms and glossary 16
2.3.3 Description and rationale 16
2.3.4 Scope and objectives 16
2.3.5 Key parameters 16
2.3.6 Procedures 16
2.3.7 Qualification report template 17
2.3.8 Approval process 18
2.4 Installation qualification 18
2.4.1 Identifying critical components 18
2.4.2 Checking installed systems, subsystems and components 19
2.4.3 Checking electrical systems and requirements 21
2.4.4 Checking environmental conditions 23
2.4.5 Checking spare parts 25
2.4.6 Checking auxiliary equipment 25
2.4.7 Checking information needed for the preventive maintenance
programme 25
2.4.8 Writing the IQ report 26
2.5 Operational qualification 26
2.5.1 Checking installed systems, subsystems and components 27
2.5.2 Calibration of controllers and sensors 27
2.5.3 Standard operating procedures 27
2.5.4 Control panel 28
2.5.5 Alarm tests 28
2.5.6 Temperature mapping – empty 29
2.5.7 Power failure test 30
2.5.8 Writing the OQ report 32
2.6 Performance qualification 32
2.6.1 Checking installed systems, subsystems and components 33
2.6.2 Temperature mapping – full 33
2.6.3 Temperature recovery after door opening 32
2.6.4 Writing the PQ report 33
2.7 Specific requirements for small-scale equipment 33
Bibliography 35
2
,Revision history 37
Annex 1
Deviation and corrective action report form 38
3
, WHO Expert Committee on Specifications for Pharmaceutical Preparations
Abbreviations
CAPA corrective and preventive action (procedures)
EDLM electronic data logging monitor
IATA International Air Transport Authority
IQ installation qualification
OQ operational qualification
PDA Parenteral Drug Association
PQ performance qualification
SMS short message service
SOP standard operating procedure
TTSPP time- and temperature-sensitive pharmaceutical product
UPS uninterrupted power supply
4
