Guidance on the interpretation and

implementation of European Good

Distribution Practice
Chapter 9 – Transportation

A joint publication of the European Compliance Academy and the

Pharmaceutical Quality Group of the Chartered Quality Institute

© 2013 European Compliance Academy and The Chartered Quality Institute

Version 1, October 2013

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Preface
It is of key importance that medicinal products are not only made to a high quality in accordance with
Good Manufacturing Practice, but that the quality and integrity of these products are maintained
through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes
into play.

The distribution network for medicinal products is often complex, involving many different parties.
In addition to the challenges associated with this complexity, there is also a growing threat from
criminal activities seeking to introduce falsified medicines into the legal supply chain. The European
regulators recognised several years ago that there was a need to update the content of the 1994 GDP
guideline to take into account advancements in practices and changes in legislation since it was
issued. A consultation draft was issued in mid 2011 and, following the receipt of many comments
from interested parties, a final revised version was issued in March 2013 with an effective date of 8
September 2013.

The new guideline has a much stronger focus on the quality system with clear responsibilities and
processes and the application of risk management principles. More detailed guidance is given on
most elements. New chapters relating to transportation and specific provisions for brokers have been
added.

The Pharmaceutical Quality Group issued a monograph on Pharmaceutical Distribution in 1997 and
initiated planning to revise this in line with the new regulatory guideline. Whilst undertaking this
planning it was identified that the European Compliance Academy were also planning to produce
some guidance in response to requests from members. The two organisations therefore decided to
join forces and set up a joint steering committee led by Afshin Hosseiny with Philip Butson, Ashley
McCraight and Oliver Schmidt.

An early decision was that we would initially target key chapters and issue each as it became available
rather than wait until a complete guide had been prepared. This has enabled us to shorten the time to
the provision of some guidance and also provides an opportunity for us to collect feedback and
enhance the material before issuing a complete guide. The first versions of the chapters will have
different formats and styles due to the different volunteer teams involved in their preparation which
we have chosen not to edit into a common format for the time being. We would appreciate feedback
on what works best for you, the user.

In this document, text from the EMA guideline is given in boxed italic Calibri font, followed by
guidance from the team in normal Times New Roman font. The main guidance is given in pages 3 –
18 with pages 19 – 32 providing an appendix giving examples of good and poor practices.

Please provide any feedback and suggestions for improvement using the email address
[email protected] or [email protected].

For this particular chapter on Transportation, we would like to thank the hard work of the authoring
team Ciaran Brady, Kane Edgeworth, Patrick Grey, Margaret Murphy and Tatjana Vorobiova.
Additional material was provided by Afshin Hosseiny and editing was undertaken by Philip Butson,
Afshin Hosseiny and Ashley McCraight.

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See Appendix for Good and Poor Practice and some additional information.

9.1. Principle
It is the responsibility of the supplying wholesale distributor to protect medicinal products
against breakage, adulteration and theft and to ensure that temperature conditions are
maintained within acceptable limits during transport.

Regardless of the mode of transport, it should be possible to demonstrate that the medicines
have not been exposed to conditions that may compromise their quality and integrity. A risk-
based approach should be utilised when planning transportation.

Definition/Clarification

The licensed supplier of the medicinal products (e.g. a wholesaler or manufacturer) must
ensure that products are transported so that they are received by the intended recipient ‘fit for
use’. The supply chain must have adequate security to prevent theft of product and minimise
the risk of falsified products entering the supply chain. The chosen route of transportation
must ensure that the products are maintained within their required temperature parameters at
all times. Documented evidence must be kept and be available, showing the supply chain
route that the products were distributed through and the conditions that they were exposed to
during transportation. This could be demonstrated with temperature monitoring in vehicles,
data loggers included in the shipment or previous qualification of the transportation route
(taking into account seasonal variations). All distribution of medicinal products must be
based on risk and documented accordingly, for example, taking into account the type of
product and required storage conditions, journey time, method of travel (road, sea, air), time
of year and expected external conditions.

Benefits

Ensure that only medicinal products that are fit for use are supplied to patients. Poor
storage/distribution conditions can affect the efficacy of a medicinal product resulting in the
medication not having the desired effect on the patient.

Falsification of medicines is an increasing issue on the worldwide pharmaceutical market and

results in sub-standard products being taken by patients across the world, creating a risk to
public health. Everyone involved in the pharmaceutical supply chain has a responsibility to
ensure only genuine products make it to patient level, having a robust and secure supply
chain is one way of ensuring this.

Risks

Not having a secure, risk-based supply chain can result in sub-standard products being sold
and prescribed. If a product has particular storage requirements such as +2°C to +8°C, these
conditions must be maintained so the product continues to meet the requirements of its
licence. Temperatures outside of this range will affect the efficacy of the product.

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9.2 Transportation
9.2.1
The required storage conditions for medicinal products should be maintained during
transportation within the defined limits as described by the manufacturers or on the outer
packaging.

Wholesalers and/or manufacturers should be responsible for specifying the actual label
claim on the outer packaging and in advance when shipping/transporting/distributing
product. Any appropriate temperature or special conditions required should be requested
when booking transportation and planning delivery routes. These delivery modes can
include air, sea, road and a mixture of any or all of these, for single or multiple shipments.

Normally, the manufacturer has responsibility to the Distribution/Wholesaler and the

Distribution/Wholesaler then takes over responsibility to final delivery point.

The IATA label is recommended for time and temperature sensitive products (see link below
for more information).

http://www.iata.org/whatwedo/cargo/pharma/Pages/ttlabel-faq.aspx

Benefits

If storage conditions are clearly described on the outer packaging/labelling, all stakeholders
can ensure compliance during transportation and storage.

Risks

If storage conditions are not visible, patient safety could be compromised.

9.2.2
If a deviation such as temperature excursion or product damage has occurred during
transportation, this should be reported to the distributor and recipient of the affected
medicinal products. A procedure should also be in place for investigating and handling
temperature excursions.

A temperature excursion is a deviation from the labelled storage conditions of a product for
any duration of time whether during storage or transportation. All excursions should be
successfully managed under a Quality Management System and as per the detailed
specifications in your Technical Agreements.

Corrective actions should be identified and implemented following the investigation of any
deviation in order to prevent recurrence.

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9.2.3
It is the responsibility of the wholesale distributor to ensure that vehicles and equipment
used to distribute, store or handle medicinal products are suitable for their use and
appropriately equipped to prevent exposure of the products to conditions that could affect
their quality and packaging integrity.

9.2.4
There should be written procedures in place for the operation and maintenance of all
vehicles and equipment involved in the distribution process, including cleaning and safety
precautions.

9.2.5
Risk assessment of delivery routes should be used to determine where temperature controls
are required. Equipment used for temperature monitoring during transport within vehicles
and/or containers, should be maintained and calibrated at regular intervals at least once a
year.
See sections 9.3.2 and 9.4.4 for more detail.

9.2.6
Dedicated vehicles and equipment should be used, where possible, when handling medicinal
products. Where non- dedicated vehicles and equipment are used procedures should be in
place to ensure that the quality of the medicinal product will not be compromised.

Covering 9.2.5 & 9.2.6 - What is a dedicated vehicle?

A dedicated vehicle is one which is used to transport medicinal product only. Normally it will
contain one customer’s/supplier’s product or consignment. It will normally travel from an
approved, authorised site to the approved final delivery point under controlled procedural
processes.

Some pharmaceutical companies, for example, are using dedicated vehicles to pick up
medicinal products from two or more manufacturing sites and deliver to, a number of
approved delivery points. It is essential to ensure the sharing is based on a risk management
approach. E.g. if transporting APIs and finished product, compatibility must be carefully
established.

Most likely the dedicated vehicle will be of solid side construction on air ride suspension,
with rear opening doors which will be locked/sealed. This vehicle will be fitted with
appropriate calibrated temperature controlled equipment and most likely GPS tracked, using a
GDP trained driver. The company used to supply the vehicle and driver will be an approved
transportation supplier. . A Contract/Technical Agreement should be in place with the
supplier who will be approved under appropriate QMS standards, procedures etc. The vehicle
will be well maintained, clean (with records) and suitable for medicinal products or materials

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transportation. This should include for example annual re-calibration on/before the due date,
breakdown contract and documented records.

What is a non-dedicated vehicle?

A non-dedicated vehicle is one that will carry medicinal product as well as non-medicinal
product /materials on the same vehicle.

Risks associated with non-dedicated vehicles are that medicinal products could be loaded
with other medicinal products or indeed any other types of product, e.g. Agricultural,
chemicals, food, flowers etc. These other products may be packed on pallets or loose
cartons/drums, destined for multiple delivery locations. Untrained and/or unapproved
transport contractors and sub-contractors might be used.

Non-dedicated vehicles used for collections (and deliveries) will require procedural controls
and processes that can demonstrate distribution compliance based on risk. These should be
supported by very good contracts with responsibilities/accountability clearly defined.

Benefits of using dedicated vehicles

Dedicated vehicles reduce the risk of cross-contamination and are more likely to provide a
safe, secure and traceable method of transporting medicinal product within a controlled
delivery process.

9.2.7
Deliveries should be made to the address stated on the delivery note and into the care or the
premises of the consignee. Medicinal products should not be left on alternative premises.

Delivery note Definition/clarification:

Delivery note is the document containing, but not limited to, full delivery address (including
consignee details and telephone number); customer name; protocol name; carrier details;
description and quantity of the product; shipping and storage conditions for the product.

Examples of documentation included in delivery note are: packing list; airway bill; manual
order form; Proforma invoice.

All deliveries should be accounted for and have a POD (proof of delivery - usually retained
by a carrier) available. Date, time, consignee name and signature should be documented upon
each delivery.
Deliveries of medical products considered hand-to-hand service specific to the consignee
indicated on the delivery note, therefore at no time should medical products be left on
alternative premises.

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Benefits

Medical products are delivered right the first time, to the correct consignee within the
assigned timeframe.

Temperature conditions of the medical products are adhered to up to the point of the final
delivery.

Medical products are handed into the possession of trained personnel and a final consignee
(who are able to stop temperature monitors if needed and record temperature parameters
appropriately).

Drivers who are GDP trained will know the critical importance of documentation and
especially collection, delivery and PODs.

Risks

Medical products left unattended may be lost and a POD may not be available.

Medical products delivered to an alternative consignee may be stored incorrectly.

Medical products delivered to alternative premises may be misused.

9.2.8
For emergency deliveries outside normal business hours, persons should be designated and
written procedures should be available.

Definition/Clarification

Emergency delivery may be defined as a situation where medical products need to be

delivered or picked up immediately for ‘last minute’ product needs (usually within a 24-hour
window).

Specialist carrier (premium service provider) will usually be utilised for outside normal
business hours (9am-5pm). They provide 24/7 global service via the normal operations
telephone numbers and e-mail. Contact number/person, mobile for out of hours’ contact, to
be provided at the consignee site for all deliveries.

Carriers should have SOPs (Standard Operating procedures) set out for contingencies such as
this, which will include contact numbers, address and details to successfully deliver the
product/consignment with trained drivers. SOPs for emergency deliveries should also be
available.

Benefits

100% on-time deliveries.

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 Use of specialist courier ensures online tracking; GPS tracking; performance reports
availability; proactive notification of issues.
Exceptional customer service.
Contingency plans available.
Ensure patients receive medication in emergency situations.

Risks

Medical products are not delivered on time for emergencies which places patients at risk!

Check/list:

Written SOP
available

Designated
On line/GPS
carriers/
tracking
drivers

24hrs/ 7 days
Contingency
a week
plans
service

9.2.9 (a)
Where transportation is performed by a third party, the contract in place should encompass
the requirements of Chapter 7. Transportation providers should be made aware by the
wholesale distributor of the relevant transport conditions applicable to the consignment.
Where the transportation route includes unloading and reloading or transit storage at a
transportation hub, particular attention should be paid to temperature monitoring,
cleanliness and the security of any intermediate storage facilities.

The contract

A contract is a written agreement between two or more parties which creates obligations that
are enforceable by law. Before services are provided by a vendor, a contract must be put in
place and executed by the parties. Examples of contracts include, but are not limited to,
Service Provider Agreements, Master Services Agreements and Consulting Agreements.

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The contract should detail the required mode of transportation and relevant transport conditions.
Transportation providers (carriers) should be informed by a wholesale distributor of the relevant
transport conditions at the point of scheduling the collection/pick up, usually via web based systems
or telephone/e-mail communication.

Transportation providers must have SOPs/documented procedures for temperature and environment
monitoring of the temporary storage of the drug products.

Procedure may include, but not limited to, recovery of customs/flight delayed shipments to an
appropriate controlled storage facility which can be an airline facility at the airport involved,
repacking into freshly conditioned validated packaging, dry ice replenishment and has on occasion
involved collecting in a refrigerated vehicle for delivery.

Carrier must also complete relevant inspection/audit of the temporary storage facilities. Checks should
include for example checks on temperature monitoring, cleanliness and security of any intermediate
storage facilities.

Security procedures for imports/exports should also be utilised by transportation providers.

This may consist of documented cargo inspections before, during and after the transportation. In some
instances, predetermined routes should be identified which are subject to further inspections to verify
length and time between loading point and collection; customs border; delivery destinations etc.

Check/list:

Pre-alert by a wholesale Assess and guarantee

Identify routes
distributor to a carrier temperature
for the delivery
(temperature conditions and
Contract (any unloading;
conditions; any other appropriate security
reloading
special requirements at the intermediate
required)
etc.) storage facilities

9.2.9 (b)
Provision should be made to minimise the duration of temporary storage while awaiting the
next stage of the transportation route.

The following provisions may be utilised:

Pre-clearance of the shipments where possible.

To minimise any transit or customs delays (which could result in temporary storage), careful
planning must take place prior to despatch of the shipment: pre-submission of the
shipping/customs documents to relevant Health authorities/Customs to gain approvals. No
shipments, especially temperature sensitive, must be despatched until approvals are received.

Checks for valid import licences and/or relevant health authorities’ authorisations must be
made.

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Transit delays involving temporary storage must be always treated as urgent. Alternatives
(next flights, pick up by a refrigerated vehicle, etc.) must be investigated and utilised as a
priority in all cases.

Clarification/Definition

The traditional 48-hour rule to move to the next stage of transportation in a carefully planned
well managed supply chain could still be used where possible. Of course, the type of product
using a risk based approach should be carefully considered for both planned and unplanned
events.

If your supply chain is mapped you should understand all touch points including the use of
air, sea, road and a mixture of unloading and reloading hubs, warehouses/touch points. Most
likely they will have received audits and be approved for use with written
contracts/agreements in place to ensure best practice for product protection, safety, security,
quality and compliance. Records should be available for all durations of temporary storage.

Guidance on when temporary storage facilities are required to be licensed is not harmonised
across Europe and it is important that companies are aware of, and comply with, national
regulatory expectations.

Supply chains should be mapped to identify stop over and hand over locations and risks
assessed and documented. Where identified by risk assessment, these locations should be
audited. Other risk mitigations might include temperature monitoring and vehicle security
arrangements, for example.

The ‘owner’ (title holder) of the product should be responsible for mapping the shipment
route to the next party in the supply chain.

Benefits

Minimise any transit or/and customs delays.

By ensuring all shipment documentation is up to date, shipments will not be held up or

searched.

If you have approved temporary storage facilities it will provide greater assurance that they
are suitable for your product.

Risks

Medical products are not delivered on time or temperature conditions are not adhered to at
the temporary storage.

Possibility of theft at the temporary storage and falsified medicines entering the supply chain.

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9.3. Containers, packaging and labelling
9.3.1
Medicinal products should be transported in containers that have no adverse effect on the
quality of the products, and that offer adequate protection from external influences,
including contamination.
(See after 9.3.2 for Definition; See Appendix for Good Practice and Poor Practice).

9.3.2
Selection of a container and packaging should be based on the storage and transportation
requirements of the medicinal products; the space required for the amount of medicines; the
anticipated external temperature extremes; the estimated maximum time for transportation
including transit storage at customs; the qualification status of the packaging and the
validation status of the shipping containers.

Storage conditions on product labels are based on stability data submitted as part of the
Marketing Authorisation Application. Marketing Authorisation holders may specify shipping
conditions, but in the absence of any other conditions being specified, the labelled storage
conditions should be maintained and any deviations from these referred back to the
Marketing Authorisation holder for assessment.
Shipping studies are useful in documenting temperatures from the outside of packages
to the chosen destinations. Multiple dummy shipments sent through chosen lanes
should be carried out during the seasonal extremes at both ends of the supply chain.
Studies should be designed to capture any trends or issues during transit and can take
a lot of the guess work out of the temperatures that product or packages will be
exposed to during transit. The study results will provide accurate detail to justify the
selection of packaging and containers. Your freight-forwarder or logistics company
can be an important partner in supporting this process and improving the efficiency of
capturing the data. Providing regular updates to them can also be a useful exercise
and make it easier to investigate any issues as well as show the positives.
Off the shelf or bespoke packaging solutions are available and can be supplied with
validation packages that might suit more than one destination and product type or
size. Validation packages should be assessed for suitability and also include
sufficient protection against unforeseen circumstances such as flight and customs
delays.
Some controlled packaging solutions are reusable but the cost feasibility of returning
the boxes should be assessed and SOPs put in place to monitor the packages for
damage and number of suggested uses.

Consideration should be given for the storage and transportation of medicinal products. See
Appendix, section 9.3.2 for examples.

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Shipping studies can remove a lot of the guess work from the potential conditions that
products/packages will be exposed to during transit.
Shipping studies can also be a valuable exercise when a packaging/shipment lane is already
in place but is perhaps giving issues. The data can be used to justify/update procedural
changes or product/service selection.

9.3.3
Containers should bear labels providing sufficient information on handling and storage
requirements and precautions to ensure that the products are properly handled and secured
at all times. The containers should enable identification of the contents of the containers and
the source.

Below covers 9.3.1 and 9.3.3:

Definition/Clarification

A shipping container is the vessel that is used to transport a product. It could be a lorry, van,
reefer, 20ft / 40ft steel container or active temperature control boxes.
The packaging is the carton or box that the product is placed in for transportation. It could be
a cardboard carton, validated insulated shipper, tote box etc.
Labelling is referring to the shipment labels and not the actual product labelling. All
shipments of medicinal products should bear labels showing the type of product, the required
temperature conditions and any special handling requirements.
Benefits

Choosing the correct shipping container and/or packaging and applying the appropriate labels
is essential for ensuring that medicinal products are received at the intended destination fit for
use.
Risks

Without assessing the appropriate shipping container or packaging for a product, it is likely
that the product will be subjected to temperature conditions that could adversely impact on
the efficacy of the product, and without labelling to identify the required shipping and
handling conditions, the wrong transportation method could easily be used in error, even if
the supplier has assessed what the appropriate method of transportation should be.

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9.4 Products requiring special conditions
9.4.1
In relation to deliveries containing medicinal products requiring special conditions such as
narcotics or psychotropic substances, the wholesale distributor should maintain a safe and
secure supply chain for these products in accordance with requirements laid down by the
Member States concerned. There should be additional control systems in place for delivery of
these products. There should be a protocol to address the occurrence of any theft.

9.4.2
Medicinal products comprising highly active and radioactive materials should be transported
in safe, dedicated and secure containers and vehicles. The relevant safety measures should
be in accordance with international agreements and national legislation.

9.4.1 & 9.4.2

Definition/Clarifications
As stated in this chapter over a number of sections, a safe secure supply chain must be
planned and carefully managed to meet the specific conditions based on the product
requirements.

Products such as narcotics, radioactive or psychotropic substances must be managed under

procedures that will ensure national and international safety measures are in accordance with
best practice as you source, store, transport and deliver these products.

Benefits
By having good procedures and well trained competent and experienced staff managing these
products across the supply they will be aware of the risks and ensure a tried and tested system
will deliver compliance. Any theft or issues must be covered in agreements and it must be
stated clearly who has responsibilities to address these. Processes and protocols should be in
place to manage such events successfully in a timely fashion at the correct level in all
organisations managing the supply chain.

Risks
These products are often watched carefully along supply chains and can be stolen by people
that don’t have patient safety or quality at the top of their agenda.

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9.4.3
For temperature-sensitive products, qualified equipment (e.g. thermal packaging,
temperature-controlled containers or temperature controlled vehicles) should be used to
ensure correct transport conditions are maintained between the manufacturer, wholesale
distributor and customer.

Active or passive packaging solutions can be considered as well as temperature controlled

vehicles:
‘Off the shelf’ validation packages (if available) are often suitable but if not sufficient, a
more expansive qualification exercise may be required to prove suitability of solution, for
example the thermal profile used needs to replicate the intended worse case temperature
exposure expected.

Packaging qualification exercises:

o Min/Max Loads
o Tailored thermal profiles representing required seasonal extremes (climatic
chamber profiles (based upon ISTA procedure 7D (2007))). Profile choice should
reflect extremes of temperature at shipping & receiving locations.
o Build in worst-case test times to take into account transit delays such as customs
o Vibration and compression testing can also be useful to include if required

On-going monitoring programmes (data logger position and placement density) should be
based upon the mapping exercise or qualification of the shipment method.

Having a robust approach to qualification will provide the proof of suitability to both the
regulator and the client. Completing properly documented mapping and qualification
exercises shows suitability of use for a chosen purpose and provides the best possible chance
of product being transported in the correct conditions. (Details on vehicle mapping can be
seen in Appendix, Section 9.4.4).

9.4.4
If temperature-controlled vehicles are used, the temperature monitoring equipment used
during transport should be maintained and calibrated at regular intervals. Temperature
mapping under representative conditions should be carried out and should take into account
seasonal variations.

Calibration
Equipment critical to assuring the quality of product should be calibrated according to written
procedures and an established schedule as stated in section 5.3 of the Good Manufacturing
Practice (GMP) guidelines (Part II: Basic requirements for Active Substances used as
Starting Materials). A minimum 12 month calibration interval is often chosen as the industry
standard.

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Section ‘3.3 Equipment’ of this document also refers to calibration and states a requirement
for equipment to be calibrated at defined intervals based upon a risk and reliability
assessment.

Probes should be calibrated to traceable National or International Standards, such as UKAS

(United Kingdom Accreditation Service) or NIST (National Institute of Standards &
Technology), over the operating range.

Mapping
Vehicle mapping should be carried out in Summer & Winter conditions and repeated
according to the results of a documented risk assessment or whenever significant
modifications are made to the temperature controlling equipment or vehicle.
See Appendix Section 9.4.4 for more detail.

9.4.5
If requested, customers should be provided with information to demonstrate that products
have complied with the temperature storage conditions.

Vehicle prints should be signed and archived but consideration given to:
Vehicle prints not always sufficient due to CMPs not being at product level (often
situated at top of the vehicle above the load limit line)
Vehicle print hard copies can degrade over time and become unreadable – scanned
electronic copies will provide permanent archive option
In order to prove suitable temperatures have been maintained it is advisable to have a
temperature monitoring programme in place where data loggers are placed at product level
during each shipment.
Temperature monitoring data should be assessed for each shipment and regularly reviewed
for any trends in location/route failures.

If reliance is placed on the data from the vehicle temperature logger, then it should be assured
that the location of the temperature probe ensures the data are representative of the product
temperature since there can be variation throughout the container.
Data loggers are now widely available, accurate and relatively inexpensive providing proof of
conditions during transit. A small investment in respect to the high value of medicinal
products in temperature monitoring during transit can provide valuable data for general
product release and proof of condition, especially in cases where notable events have
occurred in transit that could have compromised product temperature such as doors being left
open or product being left outside for periods of time during loading & unloading procedures.
In reality when pallets/containers are being transferred from one controlled zone to another
they will often be outside the specified temperature range. E.g. they may be at ambient
conditions. This should be minimised and there should be understanding of the criticality for
each of the products handled. This is particularly important for vaccine products. The

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situation can be controlled by setting a cumulative limit for ‘Time at ambient temperature’
(TAT), which is based on stability evidence and defined in technical agreements. Where
there are excursions from this agreed TAT, advice should be sought from the Marketing
Authorisation holder.

9.4.6
If cool packs are used in insulated boxes, they need to be located such that the product does
not come in direct contact with the cool pack. Staff must be trained on the procedures for
assembly of the insulated boxes (seasonal configurations) and on the reuse of cool packs.

Definition/Clarification

This requirement is for the use of insulated boxes using passive cooling to maintain the
product temperature, usually between +2°C to +8°C if cool packs are being used. In this
context the cool pack is likely to be frozen. It is important to ensure that cool packs do not
come into direct contact with the actual product being packed as this may result in localised
freezing of the medicine. An SOP and diagram should be available detailing the packaging
configuration for the insulated boxes in line with the validation (as described in section 9.4.3)
of the box. The SOP should also include the process for freezing the cool packs and potential
reuse of cool packs. All personnel involved in the packing of the insulated should be trained
in this SOP.

Additional Clarification:
Although this section mentions cool packs, this section is also valid for controlled room
temperature products, where the use of ‘warm packs’ are used instead of cool packs.

Examples of Cool pack used for product transport:

Benefits
Insulated boxes are an efficient method of transporting temperature sensitive products usually
in small to medium quantities. It is essential that the boxes are packed in accordance with a
validation study that has identified a packing specification that will maintain the required
temperature for the required journey time.

Page 16 of 33
Risks

Not having these processes documented and trained to personnel will result in varying levels
of temperature excursions to the packed products:

Due to insulated boxes being a passive cooling system, they are significantly influenced by
the external temperatures surrounding them. Using a packing specification validated for the
summer months (when external temperatures of +15°C to +25°C are expected) during winter
when temperatures around 0°C are observed in uncontrolled ambient vehicles, will increase
the risk of freezing the product. Alternatively, if using a winter packing specification during
the summer is likely to result in the required temperature not being maintained for long
enough.

If there isn’t adequate insulation and/or spacing between the cool packs and the product when
packing an insulated box, it can lead to the product being subjected to temperatures outside of
the required conditions (in this context below 2°C).

To minimise cost of packaging, it is possible to reuse some types of insulated packaging and
cool packs (however always follow manufacturer recommendations). When this is
appropriate, the boxes and cool packs must be checked by trained personnel for any damage
which could impact the effectiveness and safety of the box. For example, checks for cracks,
dents, holes etc. in the insulated box, and leaks or signs of leakage with the cool packs. If
signed off for reuse, cool packs must be reacclimatised to the required temperature for the
required amount of time, as defined by the validation.

Without a process in place for the reuse of cool packs and insulated boxes, it is likely that the
products temperature requirements will not be maintained. Damaged insulated boxes will
result in a change to their insulation properties and therefore a change to the timescale that
the required temperature will be maintained. Damage to the cool packs could result in less
cooling energy within the box leading to a shorter validation time, and leakage could also
contaminate the product. It is important for the reused cool packs to be reacclimatised at the
correct temperature for the required amount of time (as defined by the validated packing
specification) in order for the product to remain at the required temperature for the entire
journey

9.4.7
There should be a system in place to control the reuse of cool packs to ensure that
incompletely cooled packs are not used in error. There should be adequate physical
segregation between frozen and chilled ice packs.

Definition/Clarification
A process must be defined and documented which describes the use and reuse of cool packs
with regard to freezing them. All cool packs will have a minimum amount of time that they
must be acclimatised for before packed in an insulated container, so the process must detail

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how this is ensured. Fully and part frozen cool packs must be clearly segregated so only cool
packs which have been acclimatised for the validated time period are used.

Benefits
Cool packs will maintain the required temperature in line with the validation performed and
will minimise the risk of the product being subjected to a temperature excursion.

Risks
It is important for the reused cool packs to be reacclimatised at the correct temperature for the
required amount of time. Ice packs too cold can result in freezing the product and ice packs
too warm or not acclimatised for long enough will result in the required temperature not
being maintained for the full validation period. Without adequate segregation between fully
and partly acclimatised cool packs, the risk of using insufficiently frozen cool packs is
increased.

9.4.8
The process for delivery of sensitive products and control of seasonal temperature variations
should be described in a written procedure.

Definition/Clarification
Seasonal temperature variations can have a huge impact on the distribution of temperature
sensitive products. For example, temperatures in Southern Europe or the Middle East can
reach 50°C in summer months and in Northern Europe and Northern America temperatures
drop below -20°C during winter. This can have a great effect on the temperature of a vehicle
or insulated container. A procedure should be written to identify the different shipping
methods used to counteract the seasonal temperature variations. Refer to the MA for correct
storage conditions

Benefits
By having a documented process for defining the shipping the methods to be used for
temperature sensitive products during seasonal variations, it will minimise the risk of
temperature excursions during transportation.

Risks
If no attention is paid to seasonal temperature variations, the risk of temperature excursions
will increase dramatically. An insulated container with a packaging configuration validated at
external temperatures of 15°C to 30°C (suitable for summer shipments), being used to ship
2°C to 8°C product, is likely to freeze the product if being transported on an uncontrolled
vehicle in the middle of winter. Alternatively, an uncontrolled vehicle could be suitable for
transporting an ambient product requiring storage at less than 40°C, but if the same product
has a storage requirement of ‘Do Not Refrigerate’, an uncontrolled vehicle in the middle of
winter would not be acceptable.

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Appendix: Transportation Chapter 9 – Good and Poor Practice examples

9.1
Good Practice

A Risk Based Approach:

Know the products being supplied:

What are the storage requirements? Does the manufacturer make any further
recommendations? What quantity is being shipped?

Know the Supply Chain:

What is the distance of the journey? What routes are to be taken? Which modes of transport
are required? What is expected journey time? What are expected conditions (Northern
Germany in January, South of France in July)
Are there any points in the supply chain where delays can be anticipated, e.g. countries with a
history of customs delays?

Use this information to conduct and document a risk assessment to determine the appropriate
transportation route and equipment required.

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Risk Assessment Example

Product Storage External Storage Environmental Overall Duration Vehicle Overall

Condition Environment Risk Risk Rating Product of shipment
conditions Rating Risk Journey risk rating
Rating
Example 2°C - 8°C 28 °C 3 3 9 2 3 54

Storage condition risk rating is defined as:

0°C -30°C =1
15°C -25°C =2
2°C -8°C =3

External Environment risk rating is defined as:

Winter (2- 10 °C ) =1
Spring/Autumn (10 – 20 °C ) = 2
Summer (>20 °C ) =3

Duration of Journey risk rating is defined as:

1– 5 hrs =1
5 – 15 hrs =2
>15 hrs =3

Overall risk rating:

0-10 = very low risk
11-25 = low risk
26-40 = medium risk
41-65 = high risk
66-75 = very high risk

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What a secure supply chain should include:

Vehicles should include the following:

Solid sided vehicles, secure locking mechanisms, recorded security seals, GPS tracked,
possibly temperature controlled.
Transit Hubs should be sound, secure and clean. Risk assessments and ideally audits should
be conducted where compliant transit hubs are not used. Good practice would include such
controls as CCTV, intruder alarms, security, locked doors/access control and a fenced site.
Personnel should be GDP-trained, process trained, experienced and competent. GDP
Awareness training should cover all supply chain staff for example, office staff, warehouse
staff, facility staff including touch points/temporary storage locations and drivers.

Poor Practice
Examples:

Using curtain sided vehicles for high value, temperature sensitive products.

Shipping +15°C to +25°C product in standard shipping container during summer or winter
without data loggers.

Shipping medicinal products with unapproved Groupage (see sections 9.2.5 and 9.2.6; non-
dedicated vehicles are normally called Groupage.)

Shipping +2°C to +8°C and +15°C to +25°C product in the same temperature compartment
on a vehicle to reduce cost. Each should be in their appropriate temperature compartment.

9.2.1
Good Practice
As supply chains are becoming more complex and falsified medicines continue to be a
significant risk, understanding your supply chain is essential for successful management
under GDP.

All wholesalers/manufacturers should map out their whole supply chain and know what
controls are in place for temperature, humidity, security and risk of cross contamination at
each stage of transportation. This should include the use of all temporary storage locations,
hubs, etc. All locations should be approved and audited against specific storage/
transportation standards and requirements. See also section 9.2.9(b)

The type of product (e.g. cold chain, narcotics) must be carefully considered to ensure storage
and security in the transportation process.

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Poor Practice
Product is shipped without labelling specifying product temperature or storage requirements,
through an unapproved supply chain.

Product is left in temporary locations where product integrity, security and compliance are
not safeguarded, putting patients and products at risk.

If unsuitable transit/temporary locations are used, product compliance could be compromised.

9.2.2

Good Practice:
Temperature excursions (including extent and duration) should be notified immediately (as
per Technical Agreement terms) to the Responsible Person or the Wholesaler or Qualified
Person in the Manufacture or the recipient of the affected medicinal product in a timely
fashion and recorded.

A detailed procedure should be in place for investigating, handling and managing all
temperature excursions including during transportation. Notification of key stakeholders and
careful management of the product is also essential.

All temperature monitoring records should be regularly reviewed and approved to ascertain
whether an excursion may have occurred and a full investigation should be performed and
documented including the outcome and notification to all key stakeholders. This should
include a review and sign-off of a physical or electronic temperature printout/output from a
vehicle to ensure compliance.

Any products stored or transported that are subject to a temperature excursion should be
quarantined in a secure area until the outcome of the investigation is known and the
wholesaler, manufacturer/marketing authorisation holder should be consulted to ascertain
whether any possible product quality impact may result from the excursion.

The management of temperature excursions should be described within a procedure and

Technical Agreements, which will include any 3rd parties who have responsibilities in the
supply chain e.g. transportation companies, 3rd party storage locations/wholesalers.

Poor Practice
Wholesaler shipped a cold chain product to a customer. The product was received and signed
at goods in, as staff verified that the temperatures printout showed all temperatures during the
journey were between 2°C and 8°C. When the first box was opened an ice pack had come in
contact with the product and the product was frozen on inspection. The product was rejected.
The protocol for packing the products was not followed, as it clearly indicated that the ice
pack should never come into contact with the product.

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9.2.3 & 9.2.4

Good Practice
Covering points 9.2.3 and 9.2.4.

Use of dedicated transportation and equipment to ensure vehicles/equipment used to store,

handle and distribute products using approved transport companies and trained drivers should
ensure quality and timely delivery of products. Quality of packaging, integrity and suitability
of materials should be tested to ensure no breakage or damage in normal transportation
modes.

All transportation companies under the terms and conditions of contract (see Chapter 7)
should be approved (and ideally audited) to ensure that procedures are in place which
demonstrate, for example, all maintenance, calibrations, cleaning and safety records of
equipment used in the distribution process, so product quality is unaffected.

All approved transport companies used should be listed on your Approved Vendor/Supplier
Master List.

Poor practice
Recently a truck was loaded with 3 pallets of temperature sensitive products and the loading
took place on a Saturday morning, when the usual GDP trained staff were not working. The
load was rejected on Tuesday when it arrived in Europe because goods were contaminated.

9.2.5 & 9.2.6

Good Practice
Use of the correct vehicles and equipment, and approved suppliers will ensure products are
delivered within compliance.

Poor Practice
Use of a non-dedicated vehicle in which a strong-smelling chemical was also transported can
lead to tainting of the medicinal products.

9.2.7
Good practice:
Medical products should be delivered strictly to the address noted on the delivery note.

All deliveries must be made precisely to the consignee noted on the delivery note. No
alternative consignee should be selected unless it was agreed and approved in advance with
the supplier (manufacturer, wholesaler, etc.) and the receiving site.

In some instances, a specific time slot for receiving the delivery may be agreed up-front with
the receiving site and should be adhered to by the carrier. Site must be informed of any transit

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delays if they happen, otherwise for next-day-only deliveries, carrier must attempt to deliver
medical products before 12pm each day or as in the conditions of contract.

Drivers must record exact time of delivery and consignee details and signatures to ensure
good POD (Proof of Delivery) process.

Poor Practice
A medical product delivery was left at the reception as consignee was not available at the
time. The receptionist was off duty on that day and no one took notice of the delivery. As
supplies were temperature controlled, by the time they were handed into the possession of
final consignee, supplies were passed the assigned validation period.

9.2.8
Good practice:
For any emergency deliveries use of a specialist carrier is necessary. For the deliveries
outside normal business hours, an SOP must be in place defining the following:

They provide 24/7 global service via the normal operations telephone numbers and e-mail.

Contact number/person, mobile for out-of-hours contact, to be provided at the consignee site
for all deliveries.

Use of appropriately GDP trained drivers only.

Online/GPS 24/7 tracking.

Contingency plans (for example, track by road if flight was cancelled and no further flights
available).

Poor Practice:
Standard courier is used for emergency deliveries which cannot guarantee delivery at the
required day/time. E.g. A lifesaving drug had an emergency delivery planned for a Friday at
3.30pm. The product was not delivered until Saturday morning. This is totally unacceptable
as it puts the patient at significant risk.

No SOP in place; no GDP trained drivers & no contingency plans.

9.2.9. (a)
Good practice:
A written contract/s must be in place between transportation company/carrier (Contract
Acceptor) and the Wholesaler or manufactures (Contract Giver) before services can
commence.

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Determined effort to establish effective and reliable communication channels between all
parties in the supply chain is a general good practice.

Specifically in relation to the minimisation of duration of temporary storage, web-based

tracking systems may be useful to flag and resolve potential or actual problems. As an
example, a site shipment to France was collected by a carrier from the wholesaler on Friday.
There was an airline strike in France taking place. Since the wholesaler had already alerted
the carrier via a web-based system on the upcoming shipment as part of their contractual
obligation, the carrier made alternative arrangements to route the shipment via road hence
avoiding delays by air.

Poor practice:
A medical product shipment was stopped at customs due to customs officer requiring further
documentation. The shipment was time and temperature sensitive. Customs clearance took
longer than anticipated and as a result the period for which the shipper was validated to
maintain storage conditions was exceeded. Appropriate arrangements had not been made to
match the validation of the shipper with the potential for customs delays.

9.2.9 (b)
Good Practice
If you plan and map your supply chain there should be no surprises in any facilities used for
temporary storage. GPS and track-and-trace techniques should be used to manage the
movement of your products. Devices are now available that can be placed on a pallet or
individual box so you will always know where your product actually is at any point in time.

Where possible, use licenced sites that have successfully passed regulatory inspections for
temporary storage. These sites will ensure under their Quality Management System a safe,
clean, secure temperature compliant facility with documentation and records to demonstrate
compliance to your specific product requirements. Never underestimate and carefully plan
customs clearance and use 3PL/logistics partners that have the expertise and trained staff to
manage your full supply chain successfully and will inform you immediately (as per signed
agreements) of any unplanned events with your products.

Poor Practice
The pallet below arrived as one pallet of a 5-pallet delivery. As you can see it is extremely
dirty (the shrink wrap should only show pristine white boxes as it is clear shrink wrap). A
footprint is evident on the top of the pallet where the integrity is broken.

These 5 pallets arrived from a manufacturer to a large wholesaler, who could not believe a
delivery could arrive in such condition. After investigation, they discovered that the pallets
were in a temporary storage location for almost two weeks (over Christmas and New Year) in
an unapproved facility, with no licence, no security, no temperature control etc.

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The pallets were all rejected.

9.3.1 & 9.3.3

Good Practice
The required shipping container should be chosen based on the product;
storage/transportation conditions, quantity to be shipped and route of shipping. For example,
a small quantity of high value cold chain product to be shipped to Jersey would be best
placed in either an active temperature controlled container, or a validated insulated shipper.
Whereas, a 26-pallet shipment of +15°C to +25°C product being shipped from a
manufacturing plant in India to the UK, would be best shipped in a temperature controlled
reefer.

In all cases, the container being used should be checked before loading for any signs of
damage which might affect the temperature control of a vehicle or reefer. The container
should also be inspected for any signs of debris or potential contaminants left by previous
shipments such as chemicals.

Labelling of a shipment should be clear and visible. The use of diagrams such as a picture of
a thermometer (example below) is useful, particularly when shipping cross-border.

The IATA label is recommended for time and temperature sensitive products (see link below
for more information).

http://www.iata.org/whatwedo/cargo/pharma/Pages/ttlabel-faq.aspx

Poor Practice
Product shipped with no specified temperature requirements or labelling (all 15-25°C
products) in vehicles with curtains that cannot ensure temperature compliance and are not
secure or safe/acceptable practice.

No consideration of the length of journey or the number of drops and product sensitivity on
European journeys.

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9.3.2

Consideration should be given for the storage and transportation of medicinal products
Shipment method (Air/Ocean/Road).
Size/value/weight of product.
Label requirements: Temperature specified on product labelling.
Route and time requirements (how quickly does product need to be delivered)?
Routes: for example UK to Italy – is the delivery to 1 location, so only 1 drop? Or to 5
possible delivery locations, so 5 drops? There is a totally different risk for the product quality
from one delivery point to 5 delivery points. Specific risk assessment must be included in the
temperature qualification for the full delivery process mindful of many other variables
including seasonality.
Temperature control method (e.g. Dry ice/cool packs, will dry ice need to be replenished
during transit?).
Reusable or single use options.
If validation packages are available from the packaging supplier (assessing their suitability
for your requirement). Considering solutions that might suit more than one destination and
product type/size to reduce solution requirements/costs.
If time & resource permitting - Shipping studies/Route Qualification (OQ/PQ) exercises in
advance of solution selection taking into account seasonal extremes at shipping and receiving
locations can be very useful.
Sending multiple dummy shipments via required shipment lane with loggers attached to
outside of packaging/vehicle/container to build a performance database of:

Temperature results (internal vs. external where possible)

Transit times (Identify possible risk areas/delays, including temporary locations)
3PL/Freight Forwarder
Notable events/failures/trends during transit

Good Practice:
Documented justification for the selection of the packaging system and evidence exists that it
will perform under the known environmental conditions.

Poor Practice:
Having a solution in place without being able to demonstrate suitability of use.
Using a solution outside of its intended use (validation scope).
Reusing damaged packaging or solutions intended for single use only.

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9.4.1 & 9.4.2
Good Practice
Ensure all staff including contractors handling and managing these products are carefully
vetted, specially trained and understand their duties and responsibilities meeting national and
international legislation to ensure safe and secure handling using well proven procedures and
processes that work on a day to day basis. Records and documentation are essential and
access controls, alarms and CCTV monitoring should be used where possible to minimise
risk. Bona fides of all suppliers, customers (including collection and delivery addresses) and
supply chain partners must be established and re-verified on a regular basis and any non-
conformances managed in a timely fashion.
24/7 up to date contacts for at least three individuals, with mobile numbers included, as time
is critical if an issue arises, especially over a weekend/out of hours.

Poor Practice
An untrained driver delivered one of these products to the incorrect location on a hospital
grounds on a Friday. The POD was unreadable. Fortunately when the pre-12 o’clock delivery
did not arrive as normal for dispensing in the afternoon, the supplier was contacted
immediately. Happily they successfully delivered a replacement product that afternoon so the
patient was fine. The fact that the driver had delivered to the incorrect delivery point is now
subject to a full investigation. Unfortunately you don’t always get a second chance to deliver
to ensure patient safety.

9.4.3

Good Practice:
Having the required detail to prove solution suitability.
Documented results of Qualification/Validation studies carried out.
Carrying out on-going assessment of solution suitability.

Poor Practice:
Using a solution with an unsuitable validation package or having had no validation or
qualification work carried out (either a legacy product or newly chosen solution).
Using uncontrolled and/or curtain sided vehicles for movement of temperature sensitive
product.
Without temperature control, the risk to product is greatly increased.

9.4.4

Good Practice:
Ensuring a risk assessment is in place documenting the mapping process and
providing justification for the procedures implemented e.g. intervals between
mappings
Implementing a calibration schedule to avoid the calibration status of devices expiring

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 Ensuring devices are calibrated at correct range for required environment/s
Ensuring calibration is traceable to National or International standard and the
certificates produced are suitable.
Documenting any corrective actions or retests for vehicles that fail the mapping test(s)
Accuracy of recording & control equipment is vital in order to maintain the required
temperature but also to be able to prove accuracy, especially in the event of failures &
deviations.
If excursions are extreme enough to result in potential product loss the monitoring
equipment will be key to the decision making process as well as possible insurance
claims and therefore its accuracy is vital.

Calibration preferably ‘multi point’ and to include vehicle CMPs as well as control probes
providing the read out. To achieve multipoint calibrations, probes will need to have
flexibility in their length in order to be placed into a dry block calibrator. The probe can then
be exposed to conditions across the chosen range and calibrated in situ. If no probe length is
available then a reference device can be placed directly next to the probe but this will only
provide the option of a single point calibration. Multi point calibration demonstrates accuracy
across the range of the environment and should allow for equipment failures or events that
will generate unforeseen temps. For example if a fridge normally operates at +5°C but a fault
or major event results in temperatures below freezing, the probe calibration points need to
‘bracket’ the target temperature in order to offer documented accuracy at that range e.g. -5°C
/+5°C /+15°C.

Poor Practice:
Continuing to rely upon devices with a calibration status that has expired (e.g. >12
months)
Using devices outside of the checked range. E.g. using a device calibrated at
0°C/+5°C /+10°C but in +20°C conditions
Utilising vehicles that have not been mapped or properly qualified for intended use

Mapping
Vehicle to be placed ‘outside’ during mapping (large climatic chambers can be used but only
generate artificial rather than real life conditions)
Consideration should be given to representative load size, footprint & configurations during
the mapping (dummy loads to simulate FULL and HALF LOAD). EMPTY conditions can
also be considered to monitor chiller/control performance.
If the vehicle has dual compartment/temperature capability, consideration should be given to
mapping in all configuration options that will be used.
Logger placement rational for the mapping should allow for sufficient coverage of the
vehicle, covering all top & bottom corners as well as central locations. When using dummy
loads, loggers can be attached directly to the load following a similar pattern.
‘Bottom’ locations should be at pallet height (15 to 20cm) and ‘Top’ positions should
be at the highest point that the product will be placed.

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 Vehicle should be fitted with load limit lines within the vehicle to avoid product being
stacked too high, compromising air flow. ‘Top’ positions should not be higher than
the load limit line.
If additional power supply option (electrical supply) is fitted (used for ferry crossings and
overnight stops) this should be considered during the mapping term (as well as running on
engine power).
Consider air outlet temps (place probes to monitor air outlets and inlets).
Place loggers on the outside of the vehicle to document external temps; compare data to look
for any trends to internal/external data.
Note the locations of the CMPs (Continuous Monitoring Probe) within the vehicle and make
a comparison of the vehicle readings to the mapping data (take into account that the CMPs
are often placed above the load limit line and are not at product level).
Consider basic impact tests such as:
Power-down tests to document time period that the chamber maintains temperature in
event of power supply failure
Door open tests to document process of loading/unloading
o Record dates and times of start/finish of impact tests and compare to mapping
data to asses impact on environment
If using non-controlled vehicles for temperate product, mapping should still be a
consideration and part of a documented risk assessment

A comprehensive mapping with impact tests and representative loads provides documented
proof of how the vehicle operates when challenged in the chosen configurations.
It is recommended that this is supplemented by an on-going monitoring programme to
capture situations of failure in the supply chain such as traffic delays & mechanical failures -
this data will be valuable in proving product condition good or bad. The Vehicle mapping
data can be used in order to place the loggers in the highest risk areas.

9.4.5

Good Practice:
Implementing a monitoring programme based upon a basic risk assessment to justify the
quantity and position of data loggers for the shipment (e.g. Mapping data will provide detail
of the areas providing the highest risk).
Capturing enough data during shipments to be able to provide sufficient proof of transit if
requested. E.g. a study of TAT has been performed looking at the ‘Worst case scenario’ and
this is repeated when the supply routing is changed.

Poor Practice:
Relying solely on vehicle prints for product acceptance/proof of transit condition.
Having no or insufficient monitoring in place.

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9.4.6
Good Practice
Following validation studies, approved packaging specifications should be defined which
cover the expected external temperature conditions for the journey. An SOP should be in
place defining:

The type of insulated box to be used (taking into account the expected journey time and
amount of product being shipped).
The packaging specification to be used (taking into account the expected journey time and
expected external temperatures).
The use of the cool packs:
What temperature should they be acclimatised at?
How long should they be acclimatised for?
A process for identifying how long they have been acclimatised for (stock rotation).
Where they should be placed inside the insulated box.
Any precautions to prevent the cool packs coming into direct contact with product (e.g.
insulation, void filler, bubble-wrap).
The reuse of components:
Checks for damage.
Reacclimatising cool packs.

Poor Practice
Examples:

Not validating the packaging specifications at expected external conditions and journey
times.
Not preventing the cool packs from coming into direct contact with the product.
Not packing the insulated boxes in accordance with a validated packing specification.
No processes for ensuring the ice packs are acclimatised at the correct temperature for the
required amount of time.
Reusing damaged components.
Not training relevant personnel.

9.4.7
Good Practice
A defined and documented process (SOP) should be in place for stock rotation of cool packs.
There are many ways to do this depending on how long the cool packs need to be
acclimatised for, but some examples are:

Have 5 shelves in the freezer and label each one with days of the week Monday – Friday. Use
the Ice-packs from the current day and then re-fill the shelf at the end of the day (or first thing
the following day).

Have 2 zones in the freezer, load in zone 1 and then transfer to zone 2 after XX hours
(depending on validation), only use zone 2 cool packs to pack insulated containers.

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When cool packs are loaded into the freezer, use a date stamp to mark the date of entry. Cool
packs can only be used XX number of days after the stamped entry date.

Also, the use of an infrared temperature gun to check the temperature of cool packs before
use can minimise the risk of incorrectly frozen cool packs being used.

Poor Practice
Having no defined process in place is likely to result in some or all of the below examples
occurring:

Cool packs are placed randomly in the freezer.

Personnel are not sure when the cool packs were loaded.
Personnel are not sure which cool packs should be used.
Cool packs are loaded into and taken from freezers by different shifts, so personnel using the
cool packs didn’t necessarily load them, meaning that they don’t know which ones to use.
Remember, cool packs are usually identical so it is impossible to tell a partly frozen and fully
frozen cool pack apart.

9.4.8

Good Practice
The most appropriate shipping solution has been determined from knowledge of the supply
chain as defined in a procedure based on guidance in 9.4.3.

An SOP should be in place to define the controls required to deliver sensitive medicine e.g.

i) Type of packaging system for winter/summer conditions for each destination

zone.
ii) Description of the whole supply chain
iii) Responsibilities e.g. for monitoring data loggers on receipt & approving data
logger results; monitoring storage conditions are consistent with the packaging
system used etc.
iv) The expert to be contacted in the event of excursions outside predetermined
tolerances, etc.

Capture all of these variables, and someone (as defined in the SOP) should have
responsibility for deciding when summer/winter starts and ends. They should also consider
hot or cold spells outside of expected seasonal conditions and react accordingly, giving
instruction to change the current shipping method.

Poor practice
Not paying any attention to the seasonal variations will increase the risk of product being
exposed to unacceptable temperature conditions during transportation. If no temperature
studies are carried out on worst case routes (e.g. China has a very wide range of climates;
Norway in January/February or Greece in summer), the product temperatures are unknown
and could adversely affect the quality and efficacy of the products.

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Useful links

MHRA review of GDP deficiencies in 2011: http://www.mhra.gov.uk/home/groups/is-

insp/documents/websiteresources/con149838.pdf

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