MANU7007 Validation Science Project 2025 | MTU

Published: 25 Sep, 2025

Category	Assignment	Subject	Science
University	Munster Technological University (MTU)	Module Title	MANU7007: Validation Science

MANU7007 Table Of Contents

1.0 Design Features:

Task 1: Place concise and precise detail into Table 1:

Table 1: Equipment Information
System:
Purpose:
Supplier:
Application:
Key Features Description (what it is?):

Task 2: Construct a table of parameters for operation of the system

Table 2 : Operational Conditions
Parameter	Conditions	Rationale

Task 3: Based on design features and conditions, construct a drawing (Figure 1)

2.0 Results.

Task 4: Identify THREE IQ tests (Table 3) under the headings: IQ Test No, Qualification Test Name, Verification/Checking Purpose (what are you checking?). Include comprehensive detail for the Rationale i.e. the why, how and impact if failure occurred.

Table 3 :
Test No	Qualification Test Name	Verification/Checking Purpose-what are you checking?	Rationale	Ref
IQ-1
IQ-2
IQ-3

Task 5: Identify THREE OQ tests (Table 4) under the headings: OQ Test No, Qualification Test Name, Verification/Checking Purpose (what are you checking?). Include comprehensive detail for the Rationale i.e. the why, how and impact if failure occurred.

Table 4:
PQ Test No	Qualification Test Name	Verification/Checking Purpose	Ref
OQ-1
OQ-2
OQ-3

Task 6: Identify THREE considerations for completing PV (Table 5)-what do you need to verify for in PV

Table 5:
Test No	Qualification Test Name	Verification/Checking Purpose-what are you checking?	Rationale	Ref
PQ-1
PQ-2
PQ-3

Task 7: Identify THREE CQA, THREE CQI and THREE CPP of the process and include rationale to below in Table format (Tables 6-7).

Table 6:
No	CQA	CQI	Why Critical? What does it effect?	Ref
1
2
3

Table 7:
No	CPP	Why Critical? What does it effect?	Ref
1
2
3

HINT: Check out ISPE for Pharmaceutical Engineering Guides for New and renovated Facilities Volume 5 Commissioning and Qualification.
Reference your information presented.
Be concise and precise-fit concise and precise information into the tables provided. Sentences are only required not long paragraphs.

References

The department recommends the use of the Harvard Referencing System. Information on this is given in CANVAS.

Appendix I-CHAT GPT Statement

Appendix II-1 page summary of how the project was completed and Reflection

Appendix III -Brain storming tool

Appendix IV-Meeting Minutes

Include minutes of meetings (see minutes template). Summarise how the project was conducted and managed. What tools were used (social media, email etc)
Include-date, time, venue, action items, actions completed (from previous meeting), issues.
Include meeting with lecturer as a meeting minute

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Submission

DUE WK8 Monday 3rd Nov 13.00
Submit ONE hard copy (print out)-details to be confirmed.
Submit ONE project report online through CANVAS.
Your project will be processed through SIMULARITY on CANVAS for a similarity score.
Marks detected for similarity scores above 20%.
Marks deducted for late submission
Marks deducted or 0% marks will be given to team members not contributing

Important To Note In Project Writing:

Figure captions underneath
Table captions above
Include page numbers and No capitals mid sentence

Appendix I: CHAT GPT Statement

Copy and paste for each team member

Student Name	Was CHAT GPT used	Name of Tool	Research words/statements used	Extent of Tool applied	What sections applied

Appendix II: 1 Page summary of how project was conducted, what tools used and a reflection

Meet as a Team- face to face/online etc
What media platforms used-ZOOM, TEAMS, Whatsapp etc
How were documents shared-Googleapps etc?

Reflection

If you had to redo the project again what would you do differently?

Page 5 of 9

Appendix III: Brainstorming tool:

Topic is:
What is the main subject:
Relevant Definitions to research
Purpose in Biopharma-where used:
Validation aspects:	– How does it interact in the process? – Direct/indirect system? – How does the system Impact on product’s quality? – If something goes wrong what/how would this impact?
Design features: What will the system do? How does it work? What considerations will need to be decided on?

Appendix IV:

Meeting Minutes

Date
Time
Place
Meeting called by:	Type of meeting:
Facilitator:	Note taker:
Attendees:

Minutes

Agenda item:	Discussion:

Action items	Person responsible	Deadline
✓
✓
✓
✓
✓
✓

Discussion topic	Action items	Status
1.	1.

Project Titles

Project	Project Title
A	Validation of Cell Culturing: Qualification of a Bioreactor (5,000L)
B	Validation of Mixing Tank for Media prior to use in USP: Qualification of a Vessel Tank (5,000L)

Marking Scheme

Deliverables:

DESIGN (15 marks) Design Tables 1 (5 marks)
Design Conditions (5 marks)
Drawing (5 marks)
RESULTS: Body of work (66 marks)
OQ Table (18 marks)
PQ Table (18 marks)
PV (9 marks) iv. CQA defined-table (9 marks)
CQI (3 marks)
CPP Table (9 marks)

Project Report and Project Management (19 marks)
Structure, Presentation, Table of Contents (4 marks)
Appendix I- Brainstorming (5 marks)
Referencing Format (2 marks) iv. References: Source of material (3 marks)
Project Management -minutes of meetings (5 marks)

Design Features and Drawings (15 marks)

Body of Work –Results (66 marks)

Presentation, Structure, Table of Contents and List of definitions (4 marks)

Brain Storming-

Appendix I (5marks)

Application of

Harvard Referencing

System (2 marks)

Ref Sources (3 marks)

Project Mgt

& team effort

(5 marks)

EXCELL

High level of detail and covers all main points in details.

Publication LEVEL Implementation level in manufacturing (70%)

High standard of results delivery

Accurate results Detailed rationale and understanding delivered. References used

Publication LEVEL (70%)

Contains all main sections.

Exceptionally written/grammar

Excellent standard of presentation and struture

Excellent presentation of information

using diagrams/tables

Flow is good and easy to read. Publication LEVEL (70%)

Excellent detail and understands the use of the unit operation

(70%)

Used correctly.

Referencing format correct in text used.

Publication Level

Excellent source and broad range of references from difference sources

(80%)

Excellent sources, variety of references used (70%)

Publication LEVEL

Professional level

Contains majority of main points.

Missing details for operation.(60%)

Main aspects of results included in report. More effort in rationale development required.

One or two minor gaps, lacking detail/information in a few places. References used (60%)

Contains all main sections. High standard of writing, and presentation.

Tables/diagrams included.

Captions for tables/diagrams could be better.

Few grammar or spelling errors. (60%)

Comprehensive-more detail required in places (60%)

Harvard referencing system used correctly

Slight error in the referencing format correct in text used

(60%)

Very good level of research.

Recent publications Broad research from different sources from engineering and science

(60%)

Completed and

Clear.

Gmore work

Missing major details for operation.

Requires re-work of information for implementation and operation. (40%)

Main aspects presented but gaps in information in the results.

Attempted rationale.

Lacking examples/details in a lot of places.

Information vague and not complete.

Further clarity required.

References used (40%)

Fair attempt of layout/ generally expressed.

Presentation effort made.

Many grammar and spelling mistakes.

No captions.

Missing sections (40%)

Average-gap presents and has a vague idea of its operation (40%)

Some references used in introduction and discussion More effort. (50%).

Good effort, could have researched more.

4-8 references.

Average effort

A lot

effort

Major gaps, for implementation and operation

Inadequate detail.

Complete rework (<40)

Gaps in the results.

Missing results in one section. Incorrect results in places but attempt given.

Rationale incorrect or poor detail

or vague (35%)

Wrong focus.

Significant aspects not mentioned.

No rationale given in a lot of places (<35%)

Presentation, structure, layout and grammar mistakes.

Very little effort.

No use of tables/diagrams. No cations (40%)

Major gaps/wrong perspective (<40%)

Attempt at referencing system used but not the Harvard system. No references used/attempt made in text (40%).

Referencing system mixed up.

Attempt to lacking

Attempt to Lacking

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