Validation Applications: Pharmaceutical Autoclave Qualification & Essay Assignment 2025

Validation Applications Essay Assignment 2025

1. Plan the work- Decide on how you will structure the work– chapter headings/ sections etc. Roughly decide what you are going to include in each section.

2. Do rough work at the planning stage. Do not include information for the sake of it or to increase word count. It won’t make the report better. If it doesn’t help your argument, then leave it out!

3. When you use any information/ words that are not your own you must reference them. Include a list of references at the end. Use the Harvard Ref system (recommended). Information in Moodle on Harvard referencing.

4. Avoid the use of the First person throughout. ( I think, It is my opinion, You should etc). Much better to start with (It may be, It is likely, Evidently…..) Make your essay as professional as you can.

5. Your essay MUST be your own work- plagiarism and AI will result in a mark of 0. You will be uploading your essay via “turn-it-in” which is our Software plagiarism detector. I also check where I suspect AI.

6. Do NOT include any actual validations from your place of work- This is an atheoretical assignment.

7. Use of images, figures, and tables is recommended. Make sure to label them and reference them as appropriate- Tables are labelled on top of the table, and Figures are labelled underneath the figure.

8. Don’t forget to include a declaration below and put your name on your
assignment. Put the declaration at the start of the essay.

Essay Brief

A pharmaceutical manufacturer has purchased a new pharmaceutical autoclave. Explain the steps involved in the qualification/ validation of this piece of equipment. (15%) Prepare and record a 5-7 minute (approx.) PPT presentation outlining the key points from your essay (ballpark 7-10 slides) (5%) Include this declaration at the start of your essay:
By inserting & signing my name below, I declare that my essay/report, which I now submit for assessment is my own work and that any assistance I received in undertaking this work is fully acknowledged and disclosed in the document. I confirm that the Project was completed by me during the academic term that I was a student of IT Sligo.
__________________________________ ___________
Sign Date

Assignment marking will be based on the following:

Quality and depth of content/ evidence of good research 25% Assignment demonstrates a clear understanding of GMP requirements 25% Writing is supported by clear examples/ figures/ visuals 15%
Writing style, grammar, structure, and presentation of essay 15% Range of sources/ Quality of referencing 20%

Presentation:

Quality of slides/ Professional/ Effort/ Appearance 25% Information on slides 25%
Ability to condense key points and meet time requirements 25% Presentation skills 25%