PH4S017 - Quality in the Manufacture and Distribution of Medicines 16 Jul 2020 - 31 Aug 2027 | Version 3
Associated Module Information
| Module Code: | PH4S017 | ||
|---|---|---|---|
| Module Title: | Quality in the Manufacture and Distribution of Medicines | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Chemical and Environmental Sciences | ||
| Faculty Sub Group: | Chemical and Environmental Sciences | ||
| Module Leader: | Darren Evans | ||
| Module Team: | Rehana Karim, Suzanna Kean | ||
| First Intended Intake: | SEP 2018 | Final Year of Intake: | 2027 |
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 7 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100251 - pharmacy | ||
| HECOS Code Weighting: | 100 | ||
Document Version Information
| Version | 3 |
|---|---|
| Valid From | 16 Jul 2020 |
| Valid To | 31 Aug 2027 |
Module Aims
This module is aimed at personnel working in or wanting to work in the pharmaceutical industry or a related industry. The aim of the module is to provide students with a clear understanding of the underpinning principles, practice and philosophy of Quality and Quality Assurance (QA) through a range of organizational and practical considerations over the whole product life cycle of medicines
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.
Overview of the Orange Guide contents and industry relevance
Introduction to GDP– warehouse management, distribution and delivery, stock control, supply chain management
Compliance– GMP, GCP, health and safety, audits, process performance and product quality monitoring
Process improvement
Continuous improvement
Non-conformities, root cause, CAPA
Change control and management
Quality Risk Management
Product types and manufacturing processes including working in a cleanroom
Introduction to basic environmental monitoring
Clinical trials including blinding and randomisation, GMP/GCP interface
Effective communication
Customer Complaints
Drug Action
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Lecture | 36 |
| Independent Study | 100 |
| Formative Assessment - Independent | 64 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Critically evaluate the underpinning principles and requirements for Quality Systems/Quality Assurance in the context of working with medicines for human use |
| LO2 | Application of good practice in the development manufacture and wholesale distribution of medicines for human use |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Portfolio | Portfolio 1 | Scenario based problem solving based on the application of good practice in industry | 0 | 2000 | 35 | No | 40 |
| Written Assignment (CW) | Report (CW) 1 | Completion of a professional style report based on the application of one or more industry related processes linked to a real life scenario. | 0 | 3900 | 65 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | ||
| Portfolio 1 | ✔ | ✔ | |
| Report (CW) 1 | ✔ | ✔ | |