1. Model guidance for storage and transport of time and temperature-sensitive pharmaceutical products (WHO Technical Report Series, no.961, 2011, Annex 9) &Technical supplements
Umit Kartoglu/Denis Maire
Essential Medicines and Health Products

2. The MODEL GUIDANCE (Annex 9)
WHO Technical Report Series, no.961, 2011
Developed by the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management
Based upon existing regulations and best practice guidance from a wide range of international sources
For regulators, logisticians and pharmaceutical professionals in the industry, government and international agencies
The guidance should be directly applicable in less-developed countries as well as in the industrialized world.

3. The WHO guideline Objectives Buildings Management procedures Equipment
Bring developed country methodologies to bear on developing country cold chain management
Define minimum requirements for storing and transporting time & temperature-sensitive pharmaceutical products
Develop a document that covers all key components of the supply chain
Buildings
Management procedures
Equipment
Transport

4. ECBS* and ECSPP** submission
Process
The TASK FORCE – 41 members, 35 organizations, 19 countries
consultation
Public review
ECBS* and ECSPP** submission

5. Process Regulatory oversight on pharmaceutical cold chain management TF
Collection of documents
USP Chapter 1079
Health Canada Guide 0069
EC Directives
Irish Medicines Board …
Matrix display
Overlaps
Conflicting areas
Gaps
Development of minimum standards
Draft document
Reviews by the Task Force
Extended reviews
Submission to ECBS 2011

6. Document review process
Guidance harmonization process

7. Document review process

8. The WHO guideline Main section headings Importation Warehouse sites
Storage buildings
Warehouse sites
Importation
Materials handling
Temperature-controlled storage
Personnel training
Quality management
Environmental management
Labelling
General procedures and record keeping
Stock management
Transport and delivery

9. The WHO guideline Example: Typical clause format Main section headings
National guidelines: Australia, Canada, Ireland, Singapore, UK

10. The WHO guideline Next steps
Encourage member states to adopt good cold chain practices
Ensure that guidance takes account of developing country constraints
Maintain and develop the package in line with best practice
In support to the guideline, develop supplementary model guidance modules as a reference for good practices enhancement

11. The WHO guideline
GUIDELINES – Tell only WHAT needs to be done

12. Technical Supplements – Cold chain functions covered
Tell HOW it can be done – focus on topics not well addressed
Importation and port clearing (MSH)
Warehouse site selection
Warehouse design
Estimating warehouse storage capacity
Building security and fire protection
Building maintenance
Temperature monitoring of storage areas
Temperature mapping of storage areas
Qualification of temperature controlled storage areas
Calibration of control and monitoring devices
Cold chain equipment maintenance
Guidelines for warehousing health commodities (JSI)
Transport route profiling qualification
Temperature and humidity control during transport
Qualification of temperature controlled road vehicles
Qualification of shipping containers
Packing shipping containers and refrigerated vehicles
Environmental management of refrigeration equipment

13. Technical Supplements - General structure
Abbreviations
Glossary
Requirements and objectives
Requirements
Objectives
Target audience
Associated materials and equipment
Procedure
Related documents and references
Revision history

14. Temperature mapping of a storage area
Requirements
Temperature mapping of a storage area
Model Guidance

15. Procedure Step-by-step As much detail as necessary to perform
Figure 2 – Typical location of data loggers in a walk-in cold room
Step-by-step
As much detail as necessary to perform
Criteria for acceptance
Illustrations, graphics, flow charts and tables all in one style, newly created
Necessary annexes such as blank forms

16. References and annexes
International standards
Other references
If in public domain, hyperlinks
Annexes

17. Communication Electronic publishing
Distribution to all Regulatory agencies, Ministries of Health, international organizations, public and private pharmaceutical industry, supply chain professionals
Incorporate in syllabus - Pharmaceutical cold chain management on wheels and the e-learning course
Presentation at international conferences (TechNet, PDA, IQPC, VIB)

18. Feedback before finalization
Technical Supplements can be downloaded at:
Send your comments to
Feel free to further distribute the draft document