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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 [email protected]– Feel free to further distribute the draft document