1- Change management:

All changes to the processes or activities that could involve

Farmalojistik products must be approved in advance.
Change management is important in the management of vaccines products
and correct practices should be followed during the transportation, storage
and temperature monitoring. We acknowledge that even if all correct
practices are followed, it is not unusual for the transportation, temperature
monitoring and storage to experience uncontrolled situations where correct
practices deviates from the vaccines specified values and for the transport to
not follow the forecasted routes and scheduled plans. Therefore, we may
suggest any changes that can affect the products specified values shall be
notified and approved by both parties.
2- Deviation management:
The contract acceptor will use a decision tree (to be developed and
attached) that can be used to classify deviations as critical, major,
or minor. Critical deviations must be reported as soon as possible (in
less than 1 hour) after being observed.
In our group, we begin by staying that temperature excursion is one of the
common practices that frequently occurs in the vaccines transportation. In
fact, study found that, temperature excursions during transport are not rare
events and hence excursions happen at a frequency of 1 5 % of transport
events. This places transport as one of the least reliable pharmaceutical
processes, ( http://www.pharmoutsourcing.com/Featured-Articles/146648Handling-Temperature-Excursions-and-the-Role-of-Stability-Data/)
Therefore, we suggested that the contract acceptor should use a decision tree (to
be developed and attached) that can be used to classify deviations as critical,
major, or minor. For any critical deviations must be reported as soon as possible (in
less than 1 hour) after being observed in the operations.
3- Condition of vehicles:
There must be a suitable back-up vehicle available within 1 hour if
needed

Considering the effect of process delay due to vehicle issues, a back-up

vehicle is important to be available within reasonable time. Also, a back-up
vehicle should be needed within 1 hour if we observed that a particular
vehicle transporting some temperature sensitive products are not adequately
protected during the transport, which may cause drug products to degrade
and loses their therapeutic value.
In case the current vehicles are not capable of maintaining the defined
temperature range, there must be a suitable back-up vehicle available within

1 hour to be used, especially if a contracting party had agreed that vaccines

should be transported in the temperature-controlled road vehicles that are
capable of maintaining the defined temperature range until to the final
destination or final delivering point.
4- Qualifications of personnel:
All drivers must participate in a 10-hour course on Good Distribution
Practices and Good Documentation Practices.

This is to ensure that TTSPPs can be safely transported within the transport
temperature profile and that compliance can be demonstrated to all parties
involved. Vaccines are highly sensitive products and that they may have a
limited range of storage and transportation conditions. Drivers should be
aware of the transportation of TTSPPs and challenges BUT If drivers are not
aware about transportation of TTSPPs and any challenges that are involve
especially challenges that can affect the products values and qualities, they
will not follow the instructions properly. We therefore suggested that the
controls implemented for product distribution practices and good
documentation practices should be adequately monitored and validated at
all time.
5- Inspection:

Farmalojistik can audit or inspect all vehicles, records, and equipment

used to provide services to Farmalojistik customers given at least a 12hour notice.

Formalistic should clearly understand what the consequences are by using

unqualified vehicles, improper record management and poor equipment
during vaccines products storage, distribution and transport from their
facility site to patients. Therefore, we suggest they should audit or inspect all
vehicles, records, and equipment to determine their stability to address the
potential uncontrolled situation that may occur during logistics operations
and or, even in temperature excursions.
It is the right of contract giver to audit the vehicles, equipment used in
transportation of vaccines products to patients. This will assure Formalistic
customers of receiving quality products, on time and in actual quantities