MANU7007 Validation Science Project 2025 | MTU

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

Struggling with your MANU7007 Assignment

Order Non Plagiarized Assignment

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:

1. DESIGN (15 marks) Design Tables 1 (5 marks)
   Design Conditions (5 marks)
   Drawing (5 marks)
2. 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)
3. 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
VG	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 more 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.