The report should be concise while containing sufficient information to demonstrate

your understanding of why the regulators expect companies to have a sufficient

knowledge of their regulated supply chain. The work must be your own and should

include a bibliography $/$ reference list of source material.

Scenario:

An Australian sponsor has decided to sell a new product in Australia. The product is

a treatment for respiratory conditions delivered via an inhalation device $($such as an

asthma inhaler$).$ The API is manufactured under contract in Italy and the finished

product is manufactured and filled into cannisters in Italy using a different contract

manufacturer.

Product cannisters are shipped in bulk to Australia where the assembly of the final

pack $($cannister$,$ inhaler, leaflet and unit carton$)$ is completed. The inhalation device

is imported from Europe and the unit carton$/$leaflet are sourced locally in Australia.

Release for supply is preformed in Australia. The API and the finished product have

a designated storage condition of $<25$degrees C$.$

Prepare a plan $($report$)$ for the supply of the case study medicine outlined above.

This report must include the following:

$1.$ A process diagram for the movement of materials, identifying on the diagram

where physical transfers $($within one country; from one country to another$)$ are

involved in this project

$2.$ An outline of what problems and challenges $($risks$)$ you might face in

establishing a reliable supply chain for this project. You are not required to

propose mitigations for these risks but you must explain how the situations

you describe represent risks for the product quality, safety and$/$or efficacy.$$

$3.$ A list of the laws, regulations and inspection guides that are applicable for the

product and the ingredients and components.

$4.$ An outline of the requirements for transport of the cannisters from Italy to

Australia and presentation of a minimum of $2$ actual transport providers. For

each transport provider assess their suitability for the task $($through

information provided on their website$)$ and state which provider you would

choose.the options for transportation and why.

$5.$ Consideration for the principles of responsible supply chain management that

you believe are applicable to the integrity of this supply chain and supplier

quality. $($Remember$,$ PSCI in module $2).$ Include information about how you

might evaluate your chosen suppliers for compliance.

$6.$Include any assumptions made.

$7.$ Include bibliography $/$ reference list