AY2021 TERM 2 – GRADED ASSIGNMENT
|Course||:||Part-Time Diploma in Pharmaceutical Science|
|Module Name||:||Pharmaceutical and Bio-Chem Supply Chain|
Submission Date/Time : 28 JULY 2021, 2359 hrs
INSTRUCTIONS TO CANDIDATES
- This individual graded assignment will constitute 100% of the overall module marks.
- The completed graded assignment must be submitted via LEO2.0 by 28 JULY 2021, 2359 hrs.
- Late submission of the graded assignment without leave of absence (LOA) for the module will be subjected to the following late penalty:
|Time after submission deadline||Between 0 and <= 24 hours||Between 24 and <=48 hours||Between 48 and <=72 hours||After 72 hours|
|Percentage of total marks deducted by||5%||10%||15%||100%|
- Graded assignment should be uploaded into LEO 2.0, Assessment Learning Path. “CWF (Coursework Final)” folder before the stipulated deadline.
Save the report in PDF format, as “E3560CReport_<Student ID>_<Full Name>”
- This graded assignment comprises TWO parts.
- Part A to assess your knowledge and application of managing pharmaceutical product;
- Part B to assess your knowledge and application of managing Dangerous Goods (DG)
You need to submit BOTH Part A and Part B by the stated deadline.
- The marking criteria for each part is shown below:
|For Official Use|
|Content and relevance||Coherence and logical development of the ideas Details of content Relevancy of solution and plans presented to real-life situation||80 Part A -45 Part B -35|
|Format||Organisation of presentation flow with proper closure Insights of the presentation Use of terminology that correctly depicts explanations Vocal qualities (pace, inflection, volume, enunciation)||10|
|Use of proper referencing||Reliable sources of references are cited to support statements||10|
Part A – Pharmaceutical Product (45 marks) To fight Covid-19 pandemic, Singapore has brought in 2 vaccines (i.e. Moderna and Pfize) while the 3rd vaccine (i.e. Sinovac) is pending approval. The table below shows three key Convid-19 Vaccines compared: Figure 1. Key Convid-19 Vaccines compared Resource: https://www.channelnewsasia.com/news/world/covid-19-vaccines-comparison-pfizer-sinovac-moderna-13784890 You are working in ABC Pharma Logistics, and your company will be taking on the logistics services in handling the Covid-19 vaccines in Singapore. Your company will need to set up a Distribution Centre (DC) in Singapore to store and distribute the vaccines locally. You are taking the lead in setting up the warehouse and distribution operations of the vaccines. You are required to select ONE (1) out of three Covid-19 vaccines as shown in Figure 1, and write in your report, which should cover at least the following topics for your selected vaccine: Quality assurance programme(s) in the DC operations. Provide THREE (3) examples to explain in details on the importance of the scopes/components of the quality assurance programme(s) in handling the vaccines, you can make assumption of the operations in the DC in handling the vaccines. (6 marks)
Explain the storage and distribution requirements of the vaccines. You should cover proper packaging, safe storage, handling, transportation and cold chain management without compromising product quality. (12 marks)
In an online news published by “Europol” dated on the 4 December 2020 with the headline, “EUROPOL PREDICTIONS CORRECT FOR FAKE COVID-19 VACCINES”, it stated that, “In April this year, Europol announced the potential harm of offline and online scams offering alleged versions of the COVID-19 vaccine. Projections were also made in relation to the announcement of a genuine vaccine and the reaction of organised crime to adapt its methods to meet demand. These projections were later confirmed in Europol’s November report, where it was identified that the distribution of substandard and counterfeit pharmaceutical products, including preventative COVID-19 vaccines had remained a consistent pandemic-related criminal activity.” (Full article: https://www.europol.europa.eu/newsroom/news/europol-predictions-correct-for-fake-covid-19-vaccines) Knowing the potential threat of counterfeiting Covid-19 vaccines, suggest at least TWO (2) suitable anti-counterfeiting measures in details to prevent fake Covid-19 vaccines from being distributed out from the DC. (8 marks)
Besides anti-counterfeit solutions, explain how to apply TWO (2) advanced technologies to ensure the integrity and quality of the vaccine in the cold supply chain from the supplier to the end customers (i.e. patients). (8 marks)
How do you handle the expired vaccines properly in the DC? (6 marks)
If you are tasked to design a clinical trial for a new Covid-19 vaccine which is similar to the vaccines as shown in Figure 1, identify the components of the clinical trial test kit. (5 marks)
Part B – Dangerous Goods (35 marks)
In some countries, the Covid-19 situation has gone out of control and the healthcare systems are unable to cope with the rising number of cases, especially the shortage of medical oxygen for those who badly need it. Medical oxygen cylinder is considered a hazardous material/Dangerous Goods (DG). If you were to produce medical oxygen cylinders in Singapore and distribute them from Singapore to the affected countries, What is the classification of medical oxygen cylinders as a Dangerous Goods? What are the risks when handling them? (4 marks) What are FOUR (4) major challenges that you can anticipate? AND what are your recommendations to EACH challenge? (20 marks) Describe in details with explanation and illustration.
You are tasked to ship the medical oxygen cylinders from Singapore to other countries by air. Below lists THREE (3) Safety Data Sheet (SDS) of oxygen from different suppliers. SDS1 SDS2 SDS3
Choose ONE (1) SDS of oxygen and do the followings:
(Note: your answers to the questions must be based on the chosen SDS)
State the SDS of oxygen (e.g. SDS1) you have chosen and list down the product name, proper shipping name, UN number, Packing Instruction and Packing group by filling in the table below: (5 marks) SDS Product name Proper shipping name UN number Packing Instruction Packing group
Draw a GHS Label for your chosen oxygen and fill in all necessary information on the label, to enhance the protection of human health and the environment in the workplace. (6 marks)
Each student should submit the followings for grading:
- One report of at least 1500 words. The report needs to cover BOTH Part A and Part B.
- As a guideline, the report should be typed in a 12-point font, one-inch margins, and a minimum of 1.5 line spacing. Students should state clearly all citations and references used in the report. Students may also include pictures/ diagrams/ charts in your report.
You can use the report template as attached below:
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