Qualification of temperature-controlled storage areas
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Course
Qualification
Institution
Qualification
Introduction to qualification
Qualification is part of validation, but the individual qualification steps do not in
themselves constitute process validation. Validation is the entire process by
which a product is obtained from a manufacturer or distributor and is examined
and tested before i...
Supplement 7
Qualification of
temperature-controlled
storage 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
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
, 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
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
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