Technical supplements to Annex 9 Model guidance for storage and transport of time and temperature-sensitive pharmaceutical products WHO Technical Report Series, no.961, 2011

Umit Kartoglu Dept. of Essential Medicines and Health Products

Developed by the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management 42 members from 35 organizations and 19 countries

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.

The MODEL GUIDANCE (Annex 9) WHO Technical Report Series, no.961, 2011

GUIDELINES – Tell only WHAT needs to be done

“The intention is that the guidance in this document should be directly applicable in less-developed countries as well as in the industrialized world. To this end, supplementary materials will be developed to show how the requirements can practicably be achieved, particularly in resource constrained settings. Experience with vaccine supply chain assessments in many less-developed countries demonstrates that the mandatory standards set out in this document can be achieved, and that some countries are also capable of meeting many of the optional requirements.” page 328

TECHNICAL SUPPLEMENTS – tell HOW it can be done

1. Port handling and customs clearance In coordination with MSD (MSD3)

2. Estimating warehouse storage capacity Andrew Garnett

3. Warehouse design Andrew Garnett

4. Building security and fire protection Clare Barker

5. Building maintenance Andrew Garnett

6. Warehouse site selection Andrew Garnett

7. Temperature monitoring of storage areas Jean Bédard

8. Temperature mapping of storage areas Jean Bédard

9. Qualification of temperature controlled storage areas Jean Bédard

10. Calibration of control and monitoring devices Claude Haffner 11. Cold chain equipment maintenance Richard Lawton

12. Materials handling JSI / Delivery document

13. Transport route profiling qualification Kevin O’Donnell

14. Temperature and humidity control during transport Kevin O’Donnell

15. Qualification of shipping containers Kevin O’Donnell

16. Qualification of temperature-controlled road vehicles Richard Lawton

17. Packing shipping containers and refrigerated vehicles Kevin O’Donnell

18. Environmental management of refrigeration equipment Richard Lawton

Technical supplements (development 2012-2013)

1. Abbreviations

2. Glossary

3. Requirements and objectives

Requirements

Objectives

Target audience

Associated materials and equipment

4. Procedure

5. Related documents and references

6. Revision history

Technical supplements - General structure

Technical supplements - General structure

Requirements

Model Guidance

Figure 2 – Typical location of data loggers in a walk-in cold room

Procedure

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

References and annexes

International standards Other references If in public domain, hyperlinks Annexes

Communication

Distribution to all WHO committee members, regulatory agencies, Ministries of Health, international organizations, public and private pharmaceutical industry, supply chain professionals for comments Incorporate in syllabus - Pharmaceutical cold chain management on wheels and the e-learning course Presentation at international conferences (TechNet, PDA, IQPC, VIB) Confirmed > 20-21 March 2014 Brussels Electronic publishing in Q4 2014.

Pharmaceutical Cold Chain Management on Wheels 9-14 June 2014, Izmir-Aydin-Mugla-Antalya

Learning opportunities

Bus course, 9-14 June 2014, TURKEY – kartogluu@who.int Bus course, 8-13 September 2014, GREECE – kartogluu@who.int Authentic e-learning , 12 weeks course - http://epela.net/epela_web/introduction.html 2014 5 May – 25 July 8 September – 28 November 2015 February-May