PH2S108 - Planning a Validation Strategy 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH2S108 | ||
|---|---|---|---|
| Module Title: | Planning a Validation Strategy | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | Suzanna Kean | ||
| Module Team: | |||
| First Intended Intake: | Final Year of Intake: | ||
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 5 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100078 - business and management | 100144 - pharmaceutical engineering | |
| HECOS Code Weighting: | 50 | 50 | |
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 the elements involved in planning a Validation Strategy from developing a Validation Master Plan (VMP) to preparing a process validation protocol for a validated process
Content Summary
Indicative Syllabus:
• Overview of Regulatory updates with respect to Validation
• The process validation development studies: determining the critical process parameters and quality attributes, and establishing the operational specifications
• Risk management during validation planning, and the role of ICH guidelines Q8, Q9 and Q10
• The quality plan, auditing the suppliers and vendors and their quality plans and documentation, change control, periodic reviews and ongoing quality assessments
• Preparing the product validation strategy and the validation master plan.
• Preparing the cleaning validation protocol and report.
• Health and safety considerations of the interface between the operator and the process
• The validation plan summary report
• The process validation protocol
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 | Understand current regulatory guidance with respect to Validation and preparation for the regulatory audit |
| LO2 | Develop a validation strategy for the entire lifecycle of a product for presentation to regulatory audits. |
| LO3 | Identify the critical process parameters and quality attributes for a validated process and prepare the process validation protocol. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Report 1 | Based on a case study, generate a protocol for a validated process | 0 | 2100 | 70 | No | 40 |
| Asynchronous Assessment | Literature/book/paper review 1 | Write a review of a report and how it compares to current industry practice | 0 | 1800 | 30 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Report 1 | ✔ | ✔ | ✔ |
| Literature/book/paper review 1 | ✔ | ✔ | ✔ |