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e-Pharmaceutical Cold Chain Management Course
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Ümit Kartoglu
James Vesper
Kevin O’Donnell
Andrew Garnett
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Assessing the potency of oral polio vaccine kept outside of the cold chain...
This study is the first systematic documentation of the potency of monovalent oral polio vaccine type 3 (mOPV3) kept at ambient temperatures during a polio immunization campaign in Chad. During the study test vials were exposed to temperatures of up to 47.1 ◦C, and kept outside of the 2–8 ◦C range for a maximum of 86.9 hours. This study provides proof-of-concept evidence that certain types of OPV remain potent and thus can be kept, for limited periods of time, as well as administered at ambient temperatures.
Simona Zipursky
et al.
A vaccine cold chain freezing study in PNG highlights technology needs for hot climate countries
Fourteen data loggers were packed with vaccine vials at the national vaccine store, Port Moresby, Papua New Guinea (PNG), and sent to peripheral locations in the health system. The temperatures that the data loggers recorded during their passage along the cold chain indicated that heat damage was unlikely, but that all vials were exposed to freezing temperatures at some time. The commonest place where freezing conditions existed was during transport.
Theo Wirkas
et al.
Freezing temperatures in the vaccine cold chain: A systematic literature review
The dangers of accidental freezing of vaccines in the cold chain have prompted studies throughout the globe to better characterize the risk. To date, there has been no systematic review of these studies. This analysis highlights that accidental freezing is pervasive and occurs across all segments of the cold chain…
Dipika M. Matthias
et al.
Getting started with vaccine vial monitors
Practical book in a Q&A style. Reviews the issues of how a vaccine vial monitor works, advantages and costs, getting started with vaccine vial monitors, training, and impact on programme operations in 38 questions and answers.
World Health Organization
Good distribution practices for pharmaceutical products
Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. This document sets out appropriate steps to assist in fulfilling the responsibilities involved in the different aspects of the distribution process. The guidelines are intended to apply to all steps in the distribution/supply chain.
World Health Organization
Guideline for establishing or improving primary and intermediate vaccine stores
Aimed at senior managers at the national and intermediate levels who are responsible for logistics, the book provides guidance on planning a distribution system, estimating vaccine storage needs, suitable refrigeration equipment, planning within the vaccine store, selection of storage site, power supply, building standards, and management of the procurement process.
World Health Organization
Guidelines for temperature control drug products during storage and transportation
These guidelines are intended to be applicable to all persons and companies involved in the storage and transportation of drug products. All persons and companies including fabricators, packagers/labellers, distributors, importers, and wholesalers share responsibility for ensuring that appropriate storage and transportation conditions are maintained from the point of manufacturing up to the delivery of the drug products to the final distribution point.
Health Canada, Guide 0069
Guidelines for warehousing commodities
These guidelines were written for anyone trying to meet and solve the challenges of operating a warehouse today. They are an important reference tool for managers and staff, whether they are constructing a new warehouse, implementing a new warehouse system, or redesigning their current system. The guidelines consist of four sections—human resource, layout planning, racking systems and material handling equipment, and warehouse management system. The text is augmented by detailed illustrations, including a proposed organogram for staff. Guidelines for Warehousing Health Commodities provides up-to-date information on all aspects of warehousing.
JSI, Deliver
Guidelines on the international packaging and shipping of vaccines
Guidelines on the international packaging and shipping of vaccines, has been one of the most widely used manuals in the field of immunization. It is referenced by UNICEF and PAHO in all their invitations to bid for vaccine supplies and also by countries that directly procure their vaccines. This 2005 edition takes into account new developments in the field of vaccine stability, temperature monitoring and information on recently prequalified vaccines. In addition to the updated volume per dose of vaccine, it provides data on the packed volume of diluents and droppers and includes transport-box bulking factors for countries where insulated packages are used for the storage of vaccines. A special section on temperature monitoring has been added to describe the temperature limits for international shipments.
World Health Organization
Improving temperature monitoring in the vaccine cold chain at the periphery
This intervention study was conducted in Albania to establish the superiority of the Fridge-tag® (30-day electronic refrigerator temperature logger) against thermometers. Thermometers are not sufficient to monitor temperatures in refrigerators since they miss the great majority of low and high alarms. Fridgetag ® has proven to be an effective tool in providing health workers with the information they need to take the necessary actions when there are refrigerator temperature variations…
Ümit Kartoğlu
et al.
Keep in a cool place: exposure of medicines to high temperatures in general practice during a British heatwave
Exposure of medicines to high temperatures in storage or in transit could reduce their efficacy, and most licences specify storage at 25
o
C or less. To assess whether this criterion was being met, maximum temperatures in a general practice drug cupboard and in drug bags placed in car boots were recorded for two weeks during a British heatwave (average peak daily ambient temperature 26
o
C). Also, ten neighbouring dispensing pharmacies were questioned about their temperature-control policies.
Brian Crichton
Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products (TTSPPs)
These guidelines set out the principal requirements for the safe storage and distribution of time and temperature sensitive pharmaceutical products (TTSPPs). They are based upon existing regulations and best practice guidance from a wide range of international sources, while accepting that local legislation and regulations will continue to take precedence. The target audience includes regulators, logisticians and pharmaceutical professionals in industry, government and the international agencies.
World Health Organization
Monitoring vaccine wastage at country level: Guidelines for programme managers
This document reviews the factors affecting vaccine wastage and discusses the tools available for reducing wastage and their relationships to each other, with the aim of providing assistance to programme managers to establish a system for monitoring vaccine wastage as a programme quality indicator.
Ümit Kartoğlu
Multi-dose vial policy (MDVP)
The intention of this policy brief is to define the conditions that must be followed to safely handle opened multi-dose vaccine vials, enabling vaccinators to understand which opened vaccine vials should be discarded within six hours after opening and which can be kept for use in subsequent immunization sessions for up to 28 days.
WHO Policy Statement
Risk factors for improper vaccine storage and handling in private provider offices
This study was designed to estimate the statewide prevalence of offices with suboptimal storage and handling, to identify the risk factors for suboptimal situations in the offices of private physicians, and to evaluate whether the distribution of a new National Immunization Program draft manual improved storage and handling practices.
Karen N. Bell
et al.
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs). These guidelines should also be applied to products that are already being marketed, with allowance for an appropriate transition period, e.g. upon re-registration or upon re-evaluation.
World Health Organization
Stability testing of biotechnological and biological products (ICH Topic Q5C)
The document covers the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumour necrosis factors), erythropoietins, plasminogen activators, blood plasma factors, growth hormones and growth factors, insulins, monoclonal antibodies, and vaccines consisting of well-characterized proteins or polypeptides. In addition, the guidance outlined may apply to other types of products, such as conventional vaccines, after consultation with the appropriate regulatory authorities.
International Conference on Harmonization
Stability testing of new drug substances and products (ICH Topic Q1A R2)
This revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated.
International Conference on Harmonization
Structural damages in adsorbed vaccines affected by freezing
This study was planned to evaluate structural damages in adsorbed vacccines affected by freezing using scanning electron microscopy and X-ray analysis of the elements. Scanning electron microscopy of vaccines affected by freezing showed either smooth or rough surfaced conglomerates associated with phosphate content of the precipitate. These vaccines precipitated 2-15 times faster compared to nonfrozen samples. X-ray analysis of precipitates in frozen samples confirmed that the precipitate is mainly aluminium clutters. Scanning electron microscopy confirmed that the lattice structure of bonds between adsorbent and the antigen is broken and aluminium forms conglomerates that grow in size and weight. The precipitation time of vaccines affected by freezing is 4.5 times faster on average compared to non-frozen samples. These facts form the basis of the "shake test".
W. Kurzatkowski
U. Kartoglu
et al.
Temperature sensitivity of vaccines
A very comprehensive guide on temperature sensitivity of vaccines. It describes the issues related to vaccine stabilization, with emphasis on the projected evolution of the cold chain to protect vaccines both from heat and cold exposure. It also details the stability of vaccines that are currently commonly used in national immunization programmes. The document focuses on other vaccines which are being used in some immunization programmes, and may be more used in the future. It finally provides a summary taking into consideration the future evolution of the cold chain and of future vaccines, and attempting to predict applicability of the information provided here to the immunization worker in the field.
Julie Milstien
Ümit Kartoğlu
Michel Zaffran
Tools and approaches to ensure quality of vaccines throughout the cold chain
Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems.
Ümit Kartoğlu
Julie Milstien
Use of Cool Water Packs To Prevent Freezing During Vaccine Transportation at the Country Level
This study was designed to evaluate the impact of the use of cool water packs (water packs refrigerated at 2 to 8 °C) on the cold life of vaccine transport boxes and the shelf life of the vaccines. The use of cool water packs is found to be a legitimate and safe practice for vaccines other than oral polio vaccine, so that cool water packs can safely replace frozen icepacks without any serious consequences on the ability of vaccines to confer protection against disease.
Ümit Kartoğlu
et al.
User handbook for vaccine cold rooms and freezer rooms
The handbook is intended for persons responsible for managing vaccine stores and their principal assistants. It gives general guidance and advice only.
World Health Organization
Using oral polio vaccine beyond the cold chain:
First systematic documentation of using oral polio vaccine (OPV) out of the cold chain during national immunization day (NID) campaigns in Mali. Using a crossover intervention design, vaccinators compared the transport of OPV in vaccine carriers with or without ice packs. Vaccine integrity was assured through monitoring vaccine vial monitor (VVM) status…
Ariana Halm
et al.
Vaccine stock management: Guidelines on stock records for ...
Prepared in support of the WHO-UNICEF EVSM initiative to help immunization programme managers and responsible staff at the primary and intermediate storage facilities with standard stock control tool. It reviews the necessity of information to be recorded and provides standard approaches in recording and reporting processes. It also provides examples on how to fill in forms recommended in the manual.
Ahmet Afsar
Ümit Kartoğlu
Validation of shake test for detecting freeze damage to adsorbed vaccines
This study was designed to determine the validity of the shake test for detecting freeze damage in aluminium-based, adsorbed, freeze-sensitive vaccines. The shake test had 100% sensitivity, 100% specificity and 100% positive predictive value in this study, which confirms its validity for detecting freeze damage to aluminium-based freeze-sensitive vaccines…
Ümit Kartoğlu
et al.
WHO-UNICEF statement on vaccine vial monitors implementation
Issued in 2007 for marking the 10 years of successful implementation of vaccine vial monitors, the WHO-UNICEF statement calls upon all self-procuring Member States to include VVM among the minimum requirements for vaccine purchase agreements as well as urges the donor agencies to adopt a policy explicitly calling VVM as a minimum standard in every vaccine donation...
WHO and UNICEF