Write a report to give senior management the information they need to make informed decisions about a new aseptic manufacturing facility: Pharmaceutical Validation Technology Report, TUD, Ireland
| University | Technological University Dublin (TUD) |
| Subject | Pharmaceutical Validation Technology |
Assignment Instructions:
Write a report to give senior management the information they need to make informed decisions about a new aseptic manufacturing facility. The report should cover the 5 key sections:
- Production Logistics
- Process Flow
- Site Master Plan
- Cleanroom Layout
- Utility Support Systems
There are details about what you need to cover for each of the key sections in the following pages. The report should be supplemented with relevant diagrams as noted in the section descriptors below.
Make sure to include your rationale for the proposed layouts, explaining how your proposed design meets the regulatory and GMP requirements of product quality and patient safety.
As well as the 5 sections of the report, you should also include a 300-word Introduction and a 300-word Conclusion, remembering that your audience for this report is the senior management team who will be making the decision about the new manufacturing facility.
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