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

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Table of Contents

Abbreviations 

Acknowledgements 

Glossary 

1. Introduction 

1.1 Requirements 

1.2 Objectives 

1.3 Target readership 

2. Guidance 

2.1 Associated materials and equipment 

2.2 Introduction to qualification 

2.2.1 Qualification applied to temperature-controlled storage 

2.2.2 Installation qualification 

2.2.3 Operational and performance qualification 

2.3 Qualification protocols 

2.3.1 Approval page and change control history 

2.3.2 Acronyms and glossary 

2.3.3 Description and rationale 

2.3.4 Scope and objectives 

2.3.5 Key parameters 

2.3.6 Procedures 

2.3.7 Qualification report template 

2.3.8 Approval process 

2.4 Installation qualification 

2.4.1 Identifying critical components 

2.4.2 Checking installed systems, subsystems and components 

2.4.3 Checking electrical systems and requirements 

2.4.4 Checking environmental conditions 

2.4.5 Checking spare parts 

2.4.6 Checking auxiliary equipment 

2.4.7 Checking information needed for the preventive maintenance programme 

2.4.8 Writing the IQ report 

2.5 Operational qualification 

2.5.1 Checking installed systems, subsystems and components 

2.5.2 Calibration of controllers and sensors 

2.5.3 Standard operating procedures 

2.5.4 Control panel 

2.5.5 Alarm tests 

2.5.6 Temperature mapping – empty 

2.5.7 Power failure test 

2.5.8 Writing the OQ report 

2.6 Performance qualification 

2.6.1 Checking installed systems, subsystems and components 

2.6.2 Temperature mapping – full 

2.6.3 Temperature recovery after door opening 

2.6.4 Writing the PQ report 

2.7 Specific requirements for small-scale equipment 

Bibliography 

Revision history 

Annex 1

Deviation and corrective action report form 

Supplement 7- Qualification of temperature-controlled storage areas