Supplement 15

Temperature and humidity

monitoring systems for
transport operations
Technical supplement to
WHO Technical Report Series, No. 961, 2011
Annex 9: Model guidance for the storage and transport of time- and
temperature-sensitive pharmaceutical products

May 2015

© World Health Organization 2015

WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264;
fax:  +41  22 791 4857; e-mail: bookorders@who.int). Requests for permission to reproduce or translate WHO
publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the
above address (fax: +41 22 791 4806; e-mail: permissions@who.int).
The designations employed and the presentation of the material in this publication do not imply the expression of any
opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory,
city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps
represent approximate border lines for which there may not yet be full agreement.
The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or
recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
All reasonable precautions have been taken by the World Health Organization to verify the information contained in
this publication. However, the published material is being distributed without warranty of any kind, either expressed or
implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World
Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views
expressed in this publication.
 Contents
Abbreviations 3
Acknowledgements 4
Glossary 5
1. Introduction 10
1.1 Requirements 10
1.2 Objectives 11
1.3 Target readership 11
2. Guidance 12
2.1 Associated materials and equipment 12
2.2 Temperature- and humidity-monitoring devices 12
2.2.1 Device types 13
2.2.2 Data collection, storage and retrieval 18
Bibliography 19
Revision history 20

2
Abbreviations
CI chemical indicator
ETI electronic temperature integrator
EDLM electronic data logging monitor
IATA International Air Transport Association
NIST National Institute of Standards and Technology (USA)
PDA Parenteral Drug Association
TTI time-temperature integrator
TTSPP time- and temperature-sensitive pharmaceutical product
URS user requirements specification

3
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Acknowledgements
The authors of this document are Kevin O’Donnell, Exelsius Cold Chain
Management Consultancy and member of the United States Pharmacopeia
Expert Committee on Packaging, Storage & Distribution 2010–2015 cycle,
Patrick McGrath, Berlinger USA, Dr Umit Kartoglu, WHO Geneva, and Denis
Maire, WHO Geneva.

4
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

Glossary
3PL: Third-party logistics provider – a firm that provides service to its customers
of outsourced (or "third party") logistics services for part, or all of their supply
chain management functions.
4PL: Fourth-party logistics provider – a general contractor who manages other
3PLs, truckers, forwarders, custom house agents, and others, essentially taking
responsibility for a complete logistics process for the customer.
Ancillary packaging components: Packaging elements used to protect the
TTSPP and support or enhance performance of the completed package. This may
include retainers, dunnage, secondary protective packaging, and temperature
data logging devices.
Chemical indicators: (also called markers or phase-change indicators), are
generally impregnated onto a paperboard substrate. These indicators, sometimes
referred to as critical temperature indicators, are based on a phase change or
chemical reaction that occurs as a function of temperature. Examples include
liquid crystals, waxes, polymers, and lacquers that change phase, and thereby
their appearance, as a function of temperature. Threshold type chemical indicators
are irreversible and are suitable for high or low temperatures. Temperature
threshold indicators show a response and typically are single-use devices. These
indicators provide a signal only when exposed to temperatures higher than
(ascending indicator) or lower than (descending indicator) a predetermined
threshold temperature. Progressive type chemical indicators register multiple
events in a cumulative way. As long as the device remains below the threshold
temperature no changes occur. However, whenever the threshold temperature
is exceeded the reaction is activated and the indicator starts to change. Further
temperature violations increase the change process. The indicator for this type of
device usually takes the form of a progressive colour change along a paper strip.
Critical control point (CCP): A step or procedure at which controls or checks
can be applied to prevent or reduce a hazard or risk to an acceptable or critical
level. In the context of distribution and handling of time- and temperature-
sensitive health-care products, CCPs are typically defined for those activities
where time and temperature abuse may occur or where critical processes that
can affect the performance of the packaging solution or containment system are
at risk.
Electronic data integrator (EDI): A hybrid electronic instrument intelligently
programmed like an electronic temperature indicator (ETI) with the report/
data producing capabilities of an electronic data logging monitor (EDLM) that
combines the features and functions of a go/no-go device with the record
5
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

retention and data tracking of an EDLM. It uses preprogrammed temperature

threshold intelligence to integrate post-analytic functional steps that are typically
performed by trained personnel.
Electronic data logging monitor (EDLM): A small portable device that
measures and stores temperature at a predetermined time intervals by means
of an electronic sensor. They have programmable alarm capabilities, integrated
displays, and can create reports and graphs which may be permanently stored,
shared and analysed via proprietary hardware, software, desktop application or
through hosted databases.
Electronic temperature indicator (ETI): A compact, portable device that
measures temperature over time by means of a built-in sensor. They come in a
wide range of forms, features, configurations, costs and levels of performance.
They have four basic components: a thermistor sensor, a microprocessor, a
memory chip, and power source (lithium battery).
Electronic temperature monitoring and event logger system: System for
recording and reporting air and/or product temperatures, with optional facilities
for recording and reporting specific events such as door-opening or defrost
cycles, and for issuing alarms. Such systems may be user-programmable and may
also be remotely monitored via a satellite link.
External distribution: Transport of TTSPPs through various steps in the
customer’s supply chain (i.e. transport from a pharmaceutical manufacturer’s
distribution centre, to commercial customers (including wholesalers, retailers
and buying groups), to clinical facilities or direct to the patient). Contrast with
internal distribution.
Humidity (relative humidity (RH)): The partial pressure of water vapour in air
to the vapour pressure of saturated air at a given temperature. In other words, the
RH is the amount of water vapour present, divided by the theoretical amount of
moisture that could be held by that volume of air at a given temperature.
Internal distribution: Transport of a TTSPP within a pharmaceutical
manufacturer’s internal supply chain (i.e. all internal transport from the
manufacturing plant to the packaging plant and onwards to warehouses and
distribution centres). Contrast with external distribution.
Passive systems: Systems which maintain a temperature-controlled environment
inside an insulated enclosure, with or without thermostatic regulation, using
a finite amount of preconditioned coolant in the form of chilled or frozen gel
packs, phase change materials, dry ice or others.
Pharmaceutical product: Any product intended for human use or veterinary
product intended for administration to food producing animals, presented in
6
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

its finished dosage form, that is subject to control by pharmaceutical legislation

in either the exporting or the importing state and includes products for which
a prescription is required, products which may be sold to patients without a
prescription, biologicals and vaccines. Medical devices are not included.1
Qualification: Action of proving that any premises, equipment and supporting
systems work correctly and actually lead to the expected results. The meaning
of the word validation is sometimes extended to incorporate the concept
of qualification.
Refrigerated container or reefer: A thermally insulated shipping container or
intermodal freight container, equipped with an integrated refrigeration unit,
used for the transport of TTSPPs, by road, rail or ocean freight. The refrigeration
unit requires an external electrical power supply when located at a land based
site, on a container ship or on a quay. During road transport electrical power is
typically supplied by a diesel generator.
Refrigerated vehicle: Road transport vehicle such as a van, truck or semi-trailer
whose isolated thermostatically controlled cargo compartment is maintained at
a temperature different (lower or higher) than the external ambient conditions.
The environment inside the cargo compartment may be temperature-controlled
or temperature-modified.
Refrigeration equipment: The term “refrigeration” or “refrigeration equipment”
means any equipment whose purpose is to lower air and product temperatures
and/or to control relative humidity.
Service level agreement (SLA): A service level agreement or contract is a
negotiated agreement between the customer and service provider that defines
the common understanding about materials or service quality specifications,
responsibilities, guarantees and communication mechanisms. It can either be
legally binding, or an information agreement. The SLA may also specify the
target and minimum level performance, operation or other service attributes.2
Shipping system: All components constituting a completed package including:
the outer shipping container, all internal ancillary packaging components and
temperature-stabilizing medium.
Storage temperature: The temperature range listed on the TTSPP label, and
within the regulatory filings, for long-term storage.

1
  Definition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distribution
practices for pharmaceutical products – Draft for comments.
2
  Definition from IATA. 2013/2014 Perishable cargo regulations (ePCR) & Temperature control regulations
(eTCR).
7
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Temperature excursion: An event in which a TTSPP is exposed to temperatures

outside the range(s) prescribed for storage and/or transport. Temperature ranges
for storage and transport may be the same or different; they are determined by
the product manufacturer, based on stability data.
Temperature stabilizing medium: Ice or gel packs; gel bricks, bottles or pouches;
cool water or warm water-packs; phase change materials; dry ice; rapid
evaporation media which limit exposure of packed product to excessively high
or low temperatures during transport: also referred to as refrigerants or coolants.
Temperature-controlled: Includes any environment in which the temperature is
actively or passively controlled at a level different from that of the surrounding
environment within precise predefined limits.
Temperature-modified: Includes any environment in which the temperature
is predictably maintained at a level different from that of the surrounding
environment, but is not actively or passively controlled within precise
predefined limits.
Thermistor: An electrical resistor whose resistance is greatly reduced by heating,
used for measurement and control.
Time and temperature-sensitive pharmaceutical product (TTSPP): Any
pharmaceutical good or product which, when not stored or transported within
predefined environmental conditions and/or within predefined time limits, is
degraded to the extent that it no longer performs as originally intended.
Time-temperature integrators (TTIs): Are generally chemically impregnated
onto a pulp or paperboard substrate. Their reaction rate or diffusion process
is used to estimate a temperature equivalent integrated over time. Thus, TTIs
provide a measure of accumulated heat rather than instantaneous temperature
such as a spike or critical threshold (see chemical indicators). The reactions are
irreversible – once a colour change, colour development, or diffusion process
has taken place, exposure to low temperatures will not restore the indicator to its
original state. They change colour, or are marked by a hue progression in intensity
(generally from light to dark) in response to cumulative changes in temperature,
such as heat, at a rate dependent on the Arrhenius equation. A TTI accumulates
all of the temperature conditions experienced by the product to which it is affixed.
The colour development can be customized based on the known stability of the
product, and in much the same way that most biologicals and pharmaceuticals
degrade when exposed to heat – faster at higher temperatures, and slower at
lower temperatures.
Transport temperature profile: Anticipated ambient temperature variation and
duration to which a TTSPP may be exposed during transport.
8
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

User requirement specification (URS): The attributes assigned by the user

in advance of a qualification test to establish minimum performance limits.
Sometimes referred to as a functional requirements document.
Validation: Documented testing performed under highly controlled conditions,
demonstrating that processes, methods, and systems consistently produce results
meeting predetermined acceptance criteria.3

  Parenteral Drug Association (PDA) Technical Report No. 39: Guidance for temperature controlled medicinal
3

products: Maintaining the quality of temperature-sensitive medicinal products through the transportation
environment, 2007.
9
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

1. Introduction
This technical supplement has been written to amplify the recommendations
given in section 6.5 and section 9 of WHO Technical Report Series No. 961,
2011, Annex 9: Model guidance for the storage and transport of time- and
temperature-sensitive pharmaceutical products.4
The strength, efficacy, and potency of a pharmaceutical product can
be profoundly degraded by changes in temperature. Some products may also
be affected by exposure to adverse humidity levels.5 It is not always possible
completely to prevent degradation during transport, but damage can be
minimized through good handling and storage practices, by qualifying the mode
and route of transport, and by using qualified packaging.
For quality assurance purposes, stakeholders in the supply chain should
be able to supply documentary evidence that the pharmaceutical product has not
exceeded the acceptable limits of time, temperature and humidity exposure, as
determined by the manufacturer’s stability data for the product. This evidence
is supplied by recording devices and technologies that provide a history of
temperature and/or humidity to which the product was exposed during transport
and external distribution. It is important to bear in mind that humidity can only
be measured during transport; it cannot generally be controlled.
Effective temperature and humidity monitoring is an important
component of good distribution practice (GDP) and can only be achieved if
close attention is paid to the relevant critical control points (CCPs).
The following Technical Supplements are also relevant:
■■ Qualification of temperature-controlled road vehicles
■■ Qualification of shipping containers
■■ Transport route profiling qualification
■■ Temperature-controlled transport operations
■■ Temperature and humidity monitoring systems for fixed storage areas.

1.1 Requirements
Generally speaking, the shipper is responsible for ensuring product temperature
compliance during transport. Shippers should operate under the terms of a
formal service level agreement (SLA) with their carrier(s) or logistics service

  http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf
4

  Note that it is generally considered that humidity exposure has a minimal effect on pharmaceutical
5

products that are in their original manufacturer’s packaging and further enclosed in an active or passive
shipping container. However, there may be some products for which this is an important consideration.
Card packaging and primary container labels can also be degraded by high levels of humidity.
10
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

provider(s) i.e. freight-forwarder, third-party logistics provider (3PL), fourth-

party logistics provider (4PL) or integrator. If shipping operations are carried out
in-house, they should be controlled by a comprehensive set of standard operating
procedures (SOPs).
SLAs and SOPs must clearly specify the types of temperature and
humidity monitoring device that are to be used, when and where they are to
be installed, and how the data they generate should be collected, reported
and stored.

1.2 Objectives
The objective of this Technical Supplement is to provide:
■■ A technical description of the device technologies used to record
temperature and humidity exposure during the transport life-cycle
of a pharmaceutical product.
■■ A description of the documentary evidence that should be
supplied to regulatory authorities and other interested parties so that
quality assurance and regulatory compliance can be demonstrated
and maintained.

1.3 Target readership

This supplement is intended for all those responsible for the transport of TTSPPs
from one fixed storage point to another in the supply chain. The target readership
also includes those responsible for providing evidence of temperature and
humidity exposure during this process. Monitoring temperatures in fixed storage
locations is covered by the companion Technical Supplement: Temperature and
humidity monitoring systems for fixed storage areas.
Staff responsible for transport operations need to have a good knowledge
of the various types of temperature and humidity monitoring device used in the
transport environment, together with their strengths, weaknesses and appropriate
uses. They must also be capable of operating, reading and interpreting data from
these devices and must be familiar with, and follow, good documentation practice.

11
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

2. Guidance
Temperature control during air, ocean or ground transport can be maintained
using either active or passive shipping systems. These systems are fully
described in the companion Technical Supplement: Temperature-controlled
transport operations; this supplement covers product packing, distribution and
product off-loading for the following system types:
■■ refrigerated and temperature-controlled vehicles;
■■ passive shipping systems;
■■ active shipping systems for air transport; and:
■■ active shipping systems for ocean transport.
The guidance below focuses on the selection and use of suitable
temperature monitoring devices for different legs (or stages) of the transport
operation.

2.1 Associated materials and equipment

The key physical components of a quality-assured temperature-controlled
transport system are the active and passive packaging systems in which
products are placed during transport and the monitoring devices used to record
temperature and humidity exposure within these packaging systems. The specific
characteristics of the operational environments where these monitoring devices
are used are described in the companion Technical Supplement: Temperature-
controlled transport operations.

2.2 Temperature- and humidity-monitoring devices

The main reason for choosing a temperature- or humidity-monitoring device is to
determine whether or not the quality of a pharmaceutical product has potentially
been compromised as a result of exposure to harmful or unwanted conditions.
The type of technology and the device selected should be based on a URS.
Depending on the purpose defined in the URS, the selected device may
serve as:
■■ a device for determining acceptance or rejection of a shipment;
■■ a post-use analytical tool for identifying weakness in the transport
system, for carrying out a trend analysis, or for collecting
performance data.
The level of detail provided by the available range of devices varies widely
and is dependent on the specific application and the technology used. This is a
field which is undergoing rapid technological development.
12
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

All monitoring systems must meet regulatory expectations and

requirements and must provide the evidence needed to demonstrate that
the TTSPP has not been exposed to adverse temperatures during storage or
transport. When specified to do so, the system must also be able to provide the
temperature records needed for documentation purposes.
Single-use devices should be supplied with a manufacturer’s calibration
certificate and the certificate should cover the entire temperature range over
which the device is designed to be used. These devices cannot be recalibrated.
Multiple use devices should be calibrated against a certified, traceable reference
standard once a year, unless otherwise justified. Calibration should demonstrate
the accuracy of the unit across the entire temperature range over which the
device is designed to be used.
Whenever devices are selected it is essential to consider the needs of the
specific application, including ease of use and ease of integration throughout
the supply chain. Some devices require additional software or hardware, such as
a docking station; this may not be acceptable in certain cases. Whatever device
or system is chosen, it should be accurate, stable, reliable and validated.

2.2.1 Device types

The glossary gives a full definition of each of the temperature-monitoring
devices listed below. Some of the more sophisticated electronic devices include
humidity data collection. However, it is generally considered that humidity
exposure has a minimal adverse effect on pharmaceutical products when they
are in hermetically sealed primary packaging and further enclosed in an active
or passive shipping container.
Figure 1 shows examples of the following commonly used device types
and Table 1 itemizes their features, benefits, limitations and proposed applications:
■■ chemical indicators (CIs), both threshold and progressive types, and
chemical time-temperature integrators (CTTIs);
■■ electronic temperature indicators (ETIs);
■■ electronic data logging monitors (EDLMs);
■■ electronic data integrators (EDIs);
■■ electronic temperature monitoring and event logger systems for
refrigerated vehicles (TMEL).
The accuracy and level of performance of these devices varies between
manufacturers and they should therefore be carefully selected to meet the
specific URS.

13
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Figure 1
Examples of device types

Chemical indicators (CI), chemical time-temperature integrators (CTTI)

CI: TempTime LIMITmarker™ device – threshold
indicator for high temperature
CI: Temptime FREEZEmarker ®

CI: Cold chain monitor card (progressive and CTTI: Vaccine vial monitor
threshold types in one card)

Electronic temperature indicators (ETI)

Sensitech FreezeAlert™ ®
Berlinger Q-tag Quad LogTag TICT-iS0°Tag ®

14
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

Figure 1 continued
Electronic data logging monitors (EDLM)
Libero data logger ®
LogTag TRIX-8 Temperature Recorder

Electronic data integrators (EDI)

®
Berlinger Q-tag CLm Doc ®
LogTag TIC20 VaxAlert™ Temperature Indicator

Electronic temperature monitoring and event logger systems (TMEL)

Transcan Sentinel with thermal printer

15
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Table 1
Performance characteristics of monitoring devices

Portable Fixed
CI
CTTI ETI EDLM EDI TMEL
TCI PCI

Provides go / no-go information at a ✓

✓
glance
Responds when a temperature
✓ ✓ ✓
threshold has been exceeded
Responds to a single event ✓ ✓
Irreversible change ✓ ✓ ✓ ✓
Responds to a temperature equivalent
✓
integrated over time
Responds as a result of a single and
✓ ✓
cumulative events
Response occurs as a result of
✓ ✓
cumulative exposure
Features and benefits

Visual indication: Color change, colour

development, diffusion, graphical ✓ ✓ ✓ ✓
indication
No additional equipment needed to
✓ ✓ ✓ ✓ 1 1 1
read results
Accuracy of ±0.5 °C ✓ ✓ ✓ ✓
Multiple temperature alarm threshold
✓ ✓ ✓ ✓
capabilities
Multiple time alarm threshold
✓ ✓ ✓ ✓
capabilities
Alarm parameters programmable by
✓ ✓ ✓ ✓
manufacturer only
Alarm parameters programmable by ✓ ✓ ✓
manufacturer or user
Can be used as an analytical tool ✓ ✓ ✓ ✓
Capable of producing graphs, 2
✓ ✓ ✓
numerical data and summary reports

16
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

Table 1 continued
Portable Fixed
CI
CTTI ETI EDLM EDI TMEL
TCI PCI

Single use devices are calibrated by

✓ ✓
manufacturer prior to use
Devices are individually serialized for
✓3 ✓3 ✓3 ✓ ✓ ✓ ✓
traceability
User activation required ✓ ✓ ✓ ✓ ✓
User deactivation required ✓ ✓ ✓

Accidental activation may occur if not

✓4
properly stored/transported prior to use
Monitoring upper and lower limits
at the same time requires use of two ✓ ✓ ✓
indicators
Interpretation of colour change may
✓ ✓
be affected by human factors
Not an analytical tool ✓ ✓ ✓
Standard time and temperature limits
(some customization available for ✓ ✓ ✓ ✓
high volume applications)
Limitations

Single use device ✓ ✓ ✓ ✓

No time-specific traceability ✓ ✓ ✓ ✓
Requires regular calibration ✓ ✓5 ✓
Temperature accuracy varies over
✓ ✓ ✓ ✓
operating range
Recording frequency and recording
✓ ✓
time tied to size of device memory
Additional proprietary hardware,
software application or licensing may 2
✓ ✓
be required for downloading data
12-36 month battery life ✓6 ✓ ✓ ✓
Requires professional installation ✓

17
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Table 1 continued
Portable Fixed
CI
CTTI ETI EDLM EDI TMEL
TCI PCI

Point-to-point distribution ✓ ✓ ✓ ✓ ✓ ✓
Useage

Entire life-cycle of pharmaceutical

✓
product
Key: CI: chemical indicator; TCI: threshold chemical indicator; PCI: progressive chemical indicator; CTTI: chemical
time temperature integrators; ETI: electronic temperature indicator; EDLM: electronic data logging monitor;
EDI: electronic data integrator; TMEL: electronic temperature monitoring and event logger system.
1
Some versions of these devices hace LCD screens where results can be read. However, for download,
additional equipment may be needed.
2
Some versions of these devices are downloadable and produce both graphs and detailed data sheets.
3
These devices are serialized by lot, not individually.
4
If devices are incorrectly packed during shipment from the supplier, the START button on some electronic
devices may inadvertently trigger activation. This is uncommon.
5
Applies only to multiple use devices.
6
Some devices have 5 year battery life.

2.2.2 Data collection, storage and retrieval

Different devices generate different types and amounts of information. Devices,
such as EDLMs, that record time and temperature data that can be downloaded
must be used to produce this information in accordance with the relevant
regulatory requirements for documented data storage.
In most instances, downloaded time and temperature data should be
retained for at least three years in a non-volatile format that enables the data
to be retrieved. Suitable formats include printed hard copies or a non-volatile
and retrievable electronic medium such as a computer hard drive, tape drive,
flash drive or DVD. Storage in a secure web-based data repository may also
be acceptable.
Go/no go data of the type supplied by CIs, CTTIs and ETIs should be
recorded on the appropriate product arrival report and this information should
be used to make decisions on whether to accept the TTSPP consignment
into active storage at the receiving store, or whether to quarantine it until an
investigation has taken place and a final disposition has been made.

18
 WHO Technical Report Series, No. 992, Annex 5
Supplement 15

Bibliography
■■ Association Francaise du Froid. Practical guidelines – cold chain for medicines.
Paris: Association Francaise du Froid; 2009.
■■ British Standards Institute (BSI) EN 12830:1999. Temperature recorders for
the transport, storage and distribution of chilled, frozen, deep-frozen/quick-
frozen food and ice cream. Tests, performance and suitability. London: BSI; 1999
(http://shop.bsigroup.com/en/ProductDetail/?pid=000000000019969694,
accessed 25 March 2015).
■■ International Air Transport Association (IATA). 2013/2014 Perishable cargo
regulations (ePCR) & temperature control regulations (eTCR). Geneva: IATA
(http://www.iata.org/publications/Pages/temperature-control-regulations.
aspx, accessed 25 February 2018).
■■ Parenteral Drug Association (PDA) Technical Report No. 39 (revised 2007):
guidance for temperature-controlled medicinal products: maintaining the
quality of temperature-sensitive medicinal products through the transportation
environment. Bethesda (MD): Parenteral Drug Association; 2007
(https://store.pda.org/ProductCatalog/Product.aspx?ID=1270, 25 March 2015).
■■ US Food and Drug Administration (USFDA). Title 21--Food and drugs.
Chapter I--Food and Drug Administration Department of Health and Human
Services. Subchapter A – General. Part 11 Electronic Records; Electronic
Signatures 21 CFR Part 11. Silver Spring (MD): US FDA
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.
cfm?cfrpart=11, 25 March 2015).
■■ United States Pharmacopeia. USP <1079> Good storage and shipping practices
for drug products. Rockville (MD): United States Pharmacopeia; 2009
(https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/
c1079%20USP36.pdf).
■■ United States Pharmacopeia. USP <1118> Monitoring devices – time,
temperature, and humidity. Rockville (MD): United States Pharmacopeia; 2007
(http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1118.html, accessed 25
March 2015).
■■ World Health Organization. Model guidance for the storage and transport
of time- and temperature-sensitive pharmaceutical pharmaceuticals. In:
WHO Expert Committee on Specifications for Pharmaceutical Preparations:
forty-fifth report. Geneva: World Health Organization; 2011: Annex 9
(WHO Technical Report Series, No. 961; http://apps.who.int/medicinedocs/
documents/s18683en/s18683en.pdf, accessed 10 February 2015).

19
 WHO Expert Committee on Specifications for Pharmaceutical Preparations

Revision history
Date Change summary Reason for change Approved

20