Immunization standards

WHO-PDA Pharmaceutical cold chain management on wheels

The World Health Organization (WHO) Department of Immunization, Vaccines and Biologicals (IVB), Quality, Safety and Standards (QSS) team support countries and vaccine manufacturers to strengthen and expand capacities in vaccine regulation. Along with this support, WHO/IVB/QSS manages Global Learning Opportunities for Vaccine Quality (GLO/VQ) through its accredited training centres and delivers various training courses.

Pharmaceutical cold chain management on wheels is a new WHO and Parenteral Drug Association (PDA) training course offered in association with Tip Kurumu (Medical Society - Turkey). The course was first held in Turkey in 2008.

Introduction

Members of the pharmaceutical supply chain have various global requirements to meet during storage, transport and handling of temperature sensitive products. Changing product portfolios, requirements for good storage and distribution practices, regulatory trends, quality management, and risk assessment factors bring many challenges to pharmaceutical cold chain management.

WHO’s purpose in sponsoring the course described in this document is to provide the manufacturing sector with insights into the operation of a complete cold chain from product arrival through to administration of the product to the patient.

The World Health Organization QSS team provides a "prequalification of vaccines" service to UN procurement agencies. This ensures that vaccines used in immunization services are safe and effective and that tender specifications meet the specific needs of individual country programmes . Validation of packaging and the shipping of vaccines are part of this prequalification process.

WHO also publishes guidelines on the international packaging and shipping of vaccines that form part of the contractual agreement between vaccine manufacturers and UN procurement agencies, when vaccine contracts are awarded.

Course objectives

Pharmaceutical cold chain management on wheels (PCCM on wheels) is a training course aimed at developing skills in the critical evaluation of a pharmaceutical cold chain system and improving associated supervisory skills. The course encourages participants to make direct observations at the storage and health facilities which participants will visit whilst physically travelling down the length of the cold chain. This competency based training approach is designed to offer the participants insights into the theoretical background of pharmaceutical cold chain management, combining this with real life, hands-on observation at a variety of storage and health facilities.

By the end of the 6-day training programme, the participants will be able to:

  • List and explain the importance of regulatory requirements for the pharmaceutical cold chain
  • Critically review product arrival procedures
  • Observe and evaluate the layout of a cold storage facility
  • Calculate the required volume of a storage facility
  • Evaluate the stock management system
  • Observe and assess packaging of temperature sensitive products
  • Observe and assess transport of temperature sensitive products
  • Observe and evaluate the use of temperature monitoring devices and related processes
  • Review and critically evaluate standard operating procedures
  • Assess the performance of active cooling units (cold rooms, freezer rooms, refrigerators and freezers)

Target audience

The maximum number of participants for each course is set as 15.

Primary target audience
  • Representatives from the government sector including military services involved in pharmaceutical cold chain in the areas of: regulation, inspection, planning and monitoring.
  • Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: supply, packaging, distribution, logistics and cold chain management. Manufacturers who already supply WHO prequalified products are encouraged to participate.
  • Representatives from the equipment and device manufacturing industry in the areas of: active cooling, passive cooling, temperature monitoring, and track and trace. Manufacuters who already supply WHO PQS prequalified products, or who wish to enter this market, are encouraged to participate.
Secondary target audience
  • Representatives from the pharmaceutical/biopharmaceutical/vaccine industry in the areas of: R&D, quality, regulation, and manufacturing.
  • Representatives from the government sector including military services involved in pharmaceutical cold chain in the areas of: regulation, inspection, planning and monitoring.
  • Representatives from WHO, UNICEF and other partner organizations: technical officers responsible for pharmaceutical cold chain management activities at regional level, intercountry logisticians, health officers, EPI officers, and immunization advisers whose involvement in pharmaceutical cold chain is confirmed by their organizations.
  • Members of the faculty of institutions of higher education in health professions.
  • Independent consultants.

Application procedures

Dates for the 2011 course are not yet confirmed, however, if you are interested in participating, please send a message to kartogluu@who.int.

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Last update:

10 November 2011 21:06 CET