PH1S082 - Fundamentals of Pharmaceutical Manufacturing Technologies 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH1S082 | ||
|---|---|---|---|
| Module Title: | Fundamentals of Pharmaceutical Manufacturing Technologies | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Chemical and Environmental Sciences | ||
| Faculty Sub Group: | Chemical and Environmental Sciences | ||
| Module Leader: | Suzanna Kean | ||
| Module Team: | |||
| First Intended Intake: | APR 2022 | Final Year of Intake: | |
| Date Closed: | 01 Jan 2022 | ||
| Credit Value: | 20 | Credit Level: | 4 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100144 - pharmaceutical engineering | ||
| HECOS Code Weighting: | 100 | ||
Document Version Information
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
Module Aims
The aim of this module is to give students a broad understanding of what current good manufacturing practices (cGMP) apply to the manufacture of medicinal products, and how this relates to validation. It will consider industry standard guidelines and best practices for manufacturing safe and effective medicines for the public. The course is based on the principles of quality by design, risk management and continuous improvements as per the ICH (International Conference on Harmonisation) guidelines Q8, Q9 and Q10.
Content Summary
Indicative Syllabus:
• Introduction to the manufacture of medicinal products
• The need for current Good Manufacturing Practices (cGMP)
• Validation life-cycle
• ISPE Baseline Guide 5 (Commissioning and Qualification)
• Good Automated Manufacturing Practices (GAMP 5)
• Manufacturing technologies for finished pharmaceuticals, active pharmaceutical ingredients (API), biopharmaceuticals and medical devices
• Cleaning validation
• Introduction to Risk management tools
• Harmonized regulatory compliance
This module is delivered through open/distance learning resource packs, pre-recorded lectures, problem-solving exercises and case studies.
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Independent Study | 100 |
| Directed Study | 64 |
| Formative Assessment - Independent | 36 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Determine what cGMPs apply to the manufacture of medicinal products in various countries in accordance with regional regulatory expectations and identify the similarities and differences for the manufacture of active pharmaceutical ingredients (API), biopharmaceuticals, and medical devices |
| LO2 | Apply the industry standard guidelines, including ISPE Baseline Guide 5 for Commissioning and Qualification‘, and GAMP5 (Good Automated Manufacturing Practice) to Commissioning and Qualification exercises and define what equipment systems require commissioning and what systems should be qualified in the context of new manufacturing processes. |
| LO3 | Apply a range of risk-management tools in making regulatory based decisions |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 2 | Series of Short Questions | 0 | 1200 | 30 | No | 40 |
| Asynchronous Assessment | Report 1 | Assignment on Application of GMPs in Industry | 0 | 3000 | 70 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 2 | ✔ | ✔ | ✔ |
| Report 1 | ✔ | ✔ | ✔ |