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

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.

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

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

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 2009-2010 Submission to ECBS 2011

Document review process Guidance harmonization process

Document review process

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

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

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

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

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

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

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

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

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