PH2S100 - Quality Control and Management in the Pharmaceutical Industry 01 Aug 2023 - 31 Jul 2028 | Version 2
Associated Module Information
| Module Code: | PH2S100 | ||
|---|---|---|---|
| Module Title: | Quality Control and Management in the Pharmaceutical Industry | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | Darren Evans | ||
| Module Team: | Suzanna Kean, Rehana Karim | ||
| First Intended Intake: | SEP 2021 | Final Year of Intake: | 2021 |
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 5 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100423 - pharmaceutical chemistry | 101038 - applied chemistry | |
| HECOS Code Weighting: | 50 | 50 | |
Document Version Information
| Version | 2 |
|---|---|
| Valid From | 01 Aug 2023 |
| Valid To | 31 Jul 2028 |
Module Aims
1. To provide an understanding of the specific procedures, regulatory bodies and regulatory frameworks governing the pharmaceutical industry.
2. To introduce students to the different phases/roles involved from discovery research to manufacturing to distribution in the Pharmaceutical Industry.
3. To provide a clear understanding of the underpinning principles, practice and philosophy of Quality Assurance (QA) through a range of organizational and practical considerations over the product life cycle.
4. To provide an understanding of a range of quality tools and techniques that underpin good practice requirements.
Content Summary
The module will examine the underlying principles of Quality Assurance as a key element of quality management systems which underpin the pharmaceutical, manufacturing and distribution industries.
Indicative content covered in this module includes: Industry overview and product lifecycle
Introduction to QMS/QA
The Laboratory – (Basic skills required GLP vs. GMP)
Introduction to GMP – understanding manufacturing systems, packaging, IPC’s, labelling, line clearance and changeover.
Introduction to GDP– warehouse management, distribution and delivery, stock control, supply chain management
Effective communication
Customer Complaints Process control charting, tools and techniques (including an introduction to SPC)
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Practical classes and workshops | 24 |
| Independent Study | 144 |
| Directed Study | 24 |
| Formative Assessment - Independent | 8 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Demonstrate an understanding of 1) the basic underpinning principles and requirements for Quality Management Systems/Quality Assurance and 2) of quality tools and techniques used within quality planning and process control. |
| LO2 | Demonstrate a basic knowledge of the different phases from discovery research to manufacturing and distribution and regulations found in the pharmaceutical industry. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 1 | Written Assignment (Report) | 0 | 2500 | 60 | No | 40 |
| Synchronous Online Assessment | Classroom Test - Time Constrained (Online) 1 | Completion of an online QMP or class based multiple choice assessment | 60 | N/A | 40 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | ||
| Report 1 | ✔ | ✔ | |
| Classroom Test - Time Constrained (Online) 1 | ✔ | ✔ | |