Model Guidance for the Storage and Transport of Time- and

Temperature–Sensitive Pharmaceutical Products

Background
These guidelines set out the principal requirements for the safe storage and distribution of time-
and temperature-sensitive pharmaceutical products (TTSPPs).
The document is designed to give a balanced overview of the major aspects of good storage and
distribution practice for TTSPPs. As such it deliberately includes references to requirements
which can be found in general guides to, good storage practice (GSP) and good distribution
practice (GDP).

Key Terms
 Cold Chain The process used to maintain optimal conditions during the transport,
storage, and handling of cold chain products, from the point of manufacturer to the point
of use
 Pharmaceutical product Any product intended for human use, presented in its finished
dosage form, in which products may be prescribed to patients, biologicals and vaccines.
 TTSPPs Time- and Temperature–Sensitive Pharmaceutical Products

Guidelines
I. Loading and receiving bays

a. Loading bays
Ensure that receiving and dispatch bays are designed to avoid conflict between incoming
and outgoing goods and are protected from direct sunlight, dust, dirt, rain, snow and
wind, and from extremes of heat, cold and solar radiation that could damage TTSPPs, and
measures are taken to minimize pest activity in these areas.

Reason: Protection against damage and maintenance of product quality

b. Receiving bays
Provide receiving areas with suitable equipment to clean reusable transport containers
after their contents have been unloaded, and before the containers are stored for re-use.

Reason: Protection against contamination of outgoing TTSPPs.

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II. Goods assembly areas

Provide sufficient space to receive, assemble and pack TTSPPs for dispatch under
temperature-modified conditions. Preferably, these areas should be physically close to the
temperature-controlled storage area.

Reason: Protection of TTSPPs during arrival, order assembly and dispatch.

III. Building cleanliness

• Implement a cleaning programme for all areas:
• do not allow the accumulation of dust, dirt and waste, including packaging waste;
• take precautions against spillage or breakage, and cross-contamination;
• do not permit consumption of food or beverages other than in designated areas;
• and maintain cleaning records to demonstrate compliance.
Reason: Protection against damage and contamination of TTSPPs and to minimize the
risk of pest infestation.
IV. Environmental control of ancillary areas
Ensure, where possible, that ancillary areas where TTSPPs are temporarily held during
arrival, order assembly or dispatch are:
— maintained within the temperature range specified for the goods being handled;
— maintained within the humidity range specified for goods that are adversely affected by high
relative humidity and are not sufficiently protected by their packaging;
— protected from undue exposure to direct sunlight;
— protected from the weather;
— protected against dust, dirt and waste accumulation;
— adequately ventilated;
— adequately lit to enable op

V. Emergencies and contingency planning

Make contingency arrangements for the safe storage of TTSPPs in the event of
emergencies, including, but not limited to:
— extended power supply outages;
— equipment failure; and
— vehicle breakdown during transport of TTSPPs.

Prepare action plans to deal with products subjected to temperature excursions. Ensure
that the responsible staff know, and have rehearsed, the appropriate actions to be taken in
the event of the identified emergency scenarios. Reason: Loss prevention.

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 PRIMARY AREA OF FOCUS
1. Hygiene
Facilities for the handling and storage of pharmaceutical products must be large enough to ensure
proper cleaning, storage, and airflow around pallets. There should also be a separate quarantine
area for any medications which are damaged, outdated, or deteriorating. Any signs of infestation
from animals, insects, or mold will cause a shipment to become unusable, so proper warehouse
pest control and mold prevention practices, whether in the warehouse or the trailer, are essential.
2. Security
Entry into a space where medications are being stored or transported must be carefully controlled
and available only to authorized personnel. Surveillance cameras, proper lighting, access control
keys, and automatically locking doors are all vital components of a successful security plan.
3. Temperature
Protecting the integrity of the cold chain is arguably one of the most important parts of
pharmaceutical supply chain management. Typically, ethical pharmaceuticals require storage
between 12.7 and 25 degrees Celsius. A fluctuation of only a few degrees could damage the
efficacy of a product. If there are no specific storage temperatures listed for a product, the FDA
requires them to be held at “controlled” room temperature, which means that the temperature is
that of a customary working environment and does not fluctuate drastically. This is as important
during transportation as during storage.
4. Examination and recordkeeping
Inspections are a near-constant when shipping pharmaceuticals. Whenever a shipping container
with pharmaceuticals is received, a thorough inspection should be performed for any signs of
contamination. Personnels who see such signs–for example, broken pallets, torn/damaged wrap,
or an obvious pest infestation–are required to refuse acceptance. All examinations must be
logged either on paper or into a Warehouse Management System (WMS).

PLASTIC PALLETS
Plastic pallets can help meet requirements and ensure safety and compliance with
pharmaceutical shipping regulations. Plastic shipping pallets simplify many common tasks by
providing the following advantages:
• Hygienic: Plastic is very easy to clean because it doesn’t have pores. Spills, dirt, and debris
won’t sink deep into the pallet and become difficult to remove. Plastic pallets are also less likely
to grow mold, as plastic dries thoroughly and doesn’t hold moisture.
• Ideal for cold chain environments: Supply chains with highly regulated temperatures can
cause destruction on wood pallets, as the condensation that collects on pallets as they’re moved
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between environments can seep into the pores of the wood and may even freeze, cracking or
warping the pallet and potentially causing pallet failure. Because of condensation, pallets in cold
chain environments also face increased issues with mold, making non-porous and easy-to-clean
plastic an ideal material for cold chain pallets.
• Reduce product damage: Plastic pallets have no jagged edges or nails that could puncture
packaging and lead to expensive load rejection. They’re also sturdy and uniform in dimensions,
ensuring stability in loads that ultimately reduces product damage during shipment and handling.

SUMMARY

 Over the entire length of the route from a warehouse to a recipient, medicines should be
stored in constant temperature and humidity, which should be controlled on an ongoing basis,
e.g., with appropriate sensors.
 Medications should be stored in special packaging, e.g., Styrofoam isothermal packaging or
refrigerated containers, and they cannot be exposed to harmful effects of external factors or
other medicines.
 Medicinal products also cannot come in direct contact with the ice packs. They should be
collected directly from the manufacturer or a warehouse. The entire journey should be
documented – time, changes in container temperatures.
 The entire route should be well-documented, including any potential inadequacies. It is
crucial since any improperly stored drugs can negatively affect people’s health or even life.

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