Validation, Calibration and Measurement Integrity in GMP Systems Continual Assessment 2, 2026
Continual Assessment 2
Weighting: 60% of module mark – 50% main body of presentation + 10% Storyboard
Assessment Rationale
This assessment evaluates your ability to apply critical judgement to validation and calibration practices in a GMP-regulated environment. You are expected to move beyond describing standards and instead evaluate suitability, risk, and decision-making, reflecting real professional practice.
Assessment Brief
You are a quality professional supporting a GMP-regulated manufacturing operation. Recent inspection feedback has questioned the organisation’s validation strategy, calibration control, and understanding of measurement uncertainty.
You must present a critical technical report evaluating the organisation’s approach and proposing defensible improvements under the following three-part Task structure:.
Task Structure: Task 1 (10%) plus Tasks 2-4 (50%)
Task 1 – Storyboard (10%)
Explain the planning of the presentation – task by task.
Task 2 to Task 4 – Presentation (50%)
Task 2 – Validation Strategy and GMP Compliance (35 marks) (8 – 10 slides)
- a) Critically explain the role of validation within GMP, distinguishing between initial qualification and lifecycle validation.
b) Evaluate the limitations of a ‘one-time validation’
c) Explain how risk management tools + risk-based thinkingsupport a validation strategy.
Task 3 – Calibration and Preventative Maintenance in GMP (35 marks) (8 – 10 slides)
- a) Explain the purpose of calibrationwithin GMP and its relationship to data integrity and SPC.
b) Critically evaluate the use of risk-based calibration intervals versus fixed calibration schedules.
c) Discuss the role of preventative maintenancein supporting validated and controlled processes.
Task 4 – Measurement Uncertainty and Decision-Making (30 marks) (8 – 10 slides)
- a) Explain the concept of measurement uncertaintyand how it differs from ‘error’.
b) Critically analyse how uncertainty affects process control, capability analysis and validation conclusions.
c) Discuss how poor understanding of measurement uncertainty can lead to regulatory and quality risk.
Submission Requirements
- Format: Structured technical report and Storyboard presented by Zoom c. 30 minutes. Presenter must be visible throughout the presentation.
- Slide count: 32 – 40 slides, excluding title slide, Storyboard and list of references
- Referencing: Harvard Style
- Figures/Tables: Permitted – annotated – and cited, as appropriate
- Present as a Quality decision-maker, not a checklist auditor!
Additional information received:
- Another enquiry received about whether to include examples of practical application to the CA or to just leave it in general terms. The more you can demonstrate examples of how the concepts apply, practically, the more you demonstrate your knowledge and understanding – so, yes, use examples as much as you can.
Assessment Criteria
| Criteria | 85% – 100% | 70% – 84% | 50% – 69% | 40% – 49% | 1% – 39% |
| Presentation – appearance 15% | Excellent use of graphics. Font size and spacing as required. Correct no. of slides. Easily read and understood. Good fit! ‘Next Level’ appearance. | Good use of graphics. Font size and spacing as required. Easily read and understood. Correct no. of slides. | Effective presentation – may include graphics. + up to 2 slides from required range | Adequate presentation style. . + up to 3 slides from required range | Inadequate presentation stye – well outside range of slides required. |
| Presentation – communication
15% |
Clearly communicated. Well-paced. Good flow. Within time.
Good engagement with audience. ‘Next Level’ |
Well communicated Time managed. Interesting for audience. | Effective communication, Time between 4 to 11 mins. Holds audience attention. | Adequate communication. Time between 3 to 12 mins. Holds audience attention. | Inadequate communication. Time not managed. Lost audience. |
| Content – Knowledge and Understanding
40% |
Well researched. Understanding of how concepts apply in real world demonstrated. Required information clearly delivered. ‘Next Level’ analysis – extensive synergies and critical analysis of the literature evident, supported by practical application. | Knowledge and understanding evident through clear presentation and real-world links, evidence of analysis with some synergies and some critical analysis of the literature, evident. Will also include practical application. | Sufficient knowledge and understanding evident – at least on an academic level. Will also include practical application. | Some knowledge and understanding evident – at least on a basic academic level. | Inaccuracies across the presentation. Misinterpretation of the requirements. |
| Content – Relevance and Structure 15% | On the point. Clear logical progression. Brief summary at the end. ‘Next Level’ | Relevant content, Logical progression evident. | There may be occasional divergences from topic and strain of thought. | Some divergences from topic and strain of thought. | No structure evident. Scatter-gun approach to content, |
| Referencing
15% |
Well-cited on every slide. Properly structured citations throughout and Reference Listing – as per Library Guide, at the end. Complete | Well-cited on every slide. Properly structured citations throughout and Reference Listing – as per Library Guide, at the end. | Good effort at citing evident across the presentation – Reference listing at the end – may not be formatted prop. | Effort at citing evident across the presentation – Reference listing at the end – may not be complete or correct. | Little effort at referencing.
No effort = may indicate plagiarism |
