model guidance for storage and transport of time and temperature-sensitive pharmaceutical products...

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 MaireEssential Medicines and Health Products

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.

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

• 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

Objectives

Buildings

Equipment

Transport

Management procedures

The WHO guideline

The TASK FORCE – 41 members, 35 organizations, 19 countries

consultation

Public review

ECBS* and ECSPP** submission

Process

Matrix displayOverlaps

Conflicting areas

Gaps

Collection of documentsUSP Chapter 1079

Health Canada Guide 0069

EC Directives

Irish Medicines Board

…

Development of minimum standards

Draft document

Reviews by the Task Force

Submission to ECBS 2011 Extended reviews2009-2010

Process Regulatory oversight on pharmaceutical cold chain management TF

Guidance harmonization process

Document review process

Document review process

Importation

Main section headings

Warehouse sites

Storage buildings

Temperature-controlled storage

Materials handling

Transport and delivery

Stock management

General procedures and record keeping

Labelling

Environmental management

Quality management

Personnel training

The WHO guideline

Main section headingsExample: Typical clause format

The WHO guideline

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

Next steps

The WHO guideline

The WHO guideline

GUIDELINES – Tell only WHAT needs to be done

1. Importation and port clearing (MSH)2. Warehouse site selection3. Warehouse design4. Estimating warehouse storage capacity5. Building security and fire protection6. Building maintenance7. Temperature monitoring of storage areas8. Temperature mapping of storage areas9. Qualification of temperature controlled storage areas10. Calibration of control and monitoring devices11. Cold chain equipment maintenance12. Guidelines for warehousing health commodities (JSI)13. Transport route profiling qualification14. Temperature and humidity control during transport15. Qualification of temperature controlled road vehicles16. Qualification of shipping containers17. Packing shipping containers and refrigerated vehicles18. Environmental management of refrigeration equipment

Technical Supplements – Cold chain functions covered

Tell HOW it can be done – focus on topics not well addressed

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

Requirements

Model GuidanceTemperature

mapping of a

storage area

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

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)

Feedback before finalization

– Technical Supplements can be downloaded at:http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/

– Send your comments to kartogluu@who.int– Feel free to further distribute the draft document