A company manufacturing Pharmaceutical product (e.g. Panadol) has decided to upgrade its assembly process: Regulatory Affairs Assignment, UOG, Ireland
| University | University Of Galway (UOG) |
| Subject | Regulatory Affairs Assignment |
Assignment 2 (Case Study)
Background:
A company manufacturing Pharmaceutical product (e.g. Panadol) has decided to upgrade its assembly process and move to higher-speed assembly machines. This project will involve the purchase of 3 new tableting machines in Korea and shipping them to Ireland for installation.
As Regulatory Affairs Specialist you have been assigned to this project, list out 5 key areas you need to consider to ensure no Regulations are breached during the project. Include references to specific Regulation clauses.
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