Clinical trial Clinical trials and manufacturing
Posted: Thu Mar 31, 2022 8:00 am
Clinical trial
Clinical trials and manufacturing
Learning Objective This group formative assessment will test your understanding of multiple aspects of GMP, the importance of the design principles within a manufacturing facility, as well as the documentation involved in the process as it applies to the manufacture of products in industry. This assignment will test your ability to apply good manufacturing practice principles in product dynamics. Assignment Topic You will be submitting a written component and you will be presenting your assignment to the class. You will be required to design a “mini manufacturing site" for the manufacture of a product of your choice (food product, biological product, vaccine, medical device, drug, etc.) You need to ensure that you apply all principles you have learnt in Week 1 and Week 2 (design, location, sanitation, hygiene, documentation, personnel, etc.) Scope This is a group project of groups of five to six members. This assignment will have two components: Written assignment Discuss the following aspects of your model that you have designed and how it will comply with GMP: • Premises (design, location, construction, adaptation and maintenance) • Personnel (responsibilities and managers involved) • Materials Equipment (how will you ensure all principles are applied to your model) • Sanitation and hygiene • Validation and qualification (steps that need to be taken to ensure your model complies to the relevant standards) • Risk management (which procedure(s) will you put in place to identify risk and respond accordingly) .
- Clinical Trial Clinical Trials And Manufacturing 1 (158.25 KiB) Viewed 49 times
Learning Objective This group formative assessment will test your understanding of multiple aspects of GMP, the importance of the design principles within a manufacturing facility, as well as the documentation involved in the process as it applies to the manufacture of products in industry. This assignment will test your ability to apply good manufacturing practice principles in product dynamics. Assignment Topic You will be submitting a written component and you will be presenting your assignment to the class. You will be required to design a “mini manufacturing site" for the manufacture of a product of your choice (food product, biological product, vaccine, medical device, drug, etc.) You need to ensure that you apply all principles you have learnt in Week 1 and Week 2 (design, location, sanitation, hygiene, documentation, personnel, etc.) Scope This is a group project of groups of five to six members. This assignment will have two components: Written assignment Discuss the following aspects of your model that you have designed and how it will comply with GMP: • Premises (design, location, construction, adaptation and maintenance) • Personnel (responsibilities and managers involved) • Materials Equipment (how will you ensure all principles are applied to your model) • Sanitation and hygiene • Validation and qualification (steps that need to be taken to ensure your model complies to the relevant standards) • Risk management (which procedure(s) will you put in place to identify risk and respond accordingly) .