BSc (Hons) Pharmaceutical and Medicinal Product Manufacturing
01 Jan 2022 - 31 Aug 2028
| Course Leader | Suzanna Kean |
|---|---|
| Course Team | |
| Awarding Body | University of South Wales |
| Teaching Institutions | University of South Wales |
| Modes of Study | Part Time |
Document Version
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
QAA Benchmarks
Educational Aim
Overarching Course Aims
1. To provide education at undergraduate level in aspects of Production, Engineering, Quality and Validation that are relevant to those currently working in, or wishing to work in the manufacture of BioPharmaceutical/Medicinal Technology Products.
2. To provide education to give candidates a strong grounding in modern BioPharmaceutical/Medicinal Technology science and engineering concepts with a view to the Equipment, Processes, Facilities and Quality Systems used in the manufacture of medicines in line with the various worldwide regulatory and current Good Manufacturing Practices (cGMP) guidelines.
Overarching Course Objectives
• Provision of courses that allow employees working in the BioPharmaceutical/Medical Technology or other related industries, or wishing to move into the sector, develop the necessary knowledge and skills to perform effectively as a member of a Production, Engineering, Quality or Validation Team.
• Provision of a body of knowledge, practical, technical and theoretical, that is relevant to the needs of manufacturing medicines.
• Provision of the fundamental science underpinning the manufacture of medicines.
• Provision of courses that are recognized by and relevant to the industry
• Provision of high quality industrially relevant education and training by experts from academia and industry.
• Delivery of modules in a manner that is suitable for continuing professional development and life-long learning.
Overarching Course Learning Outcomes
• Have a detailed knowledge of the Manufacture of Medicines and a broad knowledge of the fundamental science and engineering underpinning this.
• Have a practical knowledge of the Quality Systems for the regulatory environment in which medicines are manufactured.
• Have demonstrated the ability to work effectively in a team across Production, Engineering, Quality and Validation.
Learning Outcomes
| A1 | Demonstrate an understanding of the general science and mathematical principles that underpin the Pharmaceutical and Medical Product Manufacturing industry at a level of study commensurate with BSc (Hons) degree qualification. |
| A2 | Demonstrate an understanding of the technology/engineering base relevant to the Pharmaceutical and Medical Product Manufacturing industry at a level of study commensurate with BSc (Hons) degree qualification. |
| A3 | Describe the Quality Systems for the regulatory environment in which medicines are manufactured. |
| A4 | Demonstrate an understanding of the design, quality, and safety issues related to the manufacture of pharmacetucial and medicinal products at a level of study commensurate with BSc (Hons) degree qualification. |
| B1 | Appraise and apply formalised techniques related to the manufacture of Pharmaceutical and medicinal products to make safe and sound decisions. |
| B2 | Appraise and utilise data and statistics to make informed decisions about process development and continuous improvement |
| B3 | Integrate and evaluate information and data from various sources to ensure appropriate informed methodologies and practices are applied when providing solutions to unfamiliar problems. |
| B4 | Differentiate and analyse the range of processes used in the manufacture of pharmaceutical and medicinal products, recognising the contributions of production, engineering, quality and validation. |
| C1 | Plan, design and execute a piece of work, from the problem-recognition stage through to the evaluation and appraisal of results and findings; this to include the ability to select appropriate techniques and procedures and the adoption of best practice. |
| C2 | Operate under the regulations governing the Pharmaceutical and Medical Product Manufacturing industry. |
| C3 | Employ techniques and processess, including codes of practice and regulatory frameworks essential for a employee in the Pharmaceutical and Medical Product Manufacturing industry aspiring to higher roles. |
Course Structure
Level 6 Modules
| Module Code | Module Id | Module Title | Module Status | Credit Value | Module Type |
|---|---|---|---|---|---|
| PH3S107 | MOD012506 | Design and Operation of Cleanrooms | Running | 20 | specified |
| PH3S108 | MOD012507 | Regulations for the Manufacture of Combination & Device Products | Running | 20 | specified |
| PH3S109 | MOD012508 | Mathematics and Statistics for the Pharmaceutical Industry | Running | 20 | specified |
| PH3S110 | MOD012509 | Fundamentals of Physical Chemistry and Safety for the Pharmaceutical Industry | Running | 20 | specified |
| PH3S111 | MOD012510 | Process Development and Technology Transfer | Running | 20 | specified |
| PH3S112 | MOD012511 | From URS to PQ - A Practical Validation Strategy | Running | 20 | specified |
Teaching and Assessment
Learning and Teaching Methods
Employer Engagement
Means of Assessment
Learning Support
Course Exit Points
| Award | Criteria | Final |
|---|---|---|
| Bachelor of Science (with Honours) | 360 credits of which at least 100 must be at Level 6 or above, 120 at Level 5 or above, 120 at Level 4 or above and no more than 20 at Level 3 | Final |
Progression Route
Entry Requirements
Admission to the course is typically through the following qualifications:
Inclusive Curriculum Statement
The University of South Wales operates a policy of inclusive learning, teaching and assessment to ensure that all students have an equal opportunity to fulfil their educational potential. Course teams will have considered ways of designing out any potentially disadvantageous element of courses during the course design process. However some specific needs may remain, details about how to apply to have your needs assessed can be found at: http://unilife.southwales.ac.uk/pages/3040-disability-and-dyslexia-service/
Addendum for Delivery at a Partner Institution
N/A
Methods Of Quality Standards
N/A
Quality Of Standards Indicators
N/A