CHEP9005 - Quality, Validation & Risk

Module Details

Module Code: CHEP9005
Title: Quality, Validation & Risk
Long Title: Quality Validation & Risk management
NFQ Level: Expert
Valid From: Semester 1 - 2024/25 ( September 2024 )
Duration: 1 Semester
Credits: 10
Field of Study: 5240 - Chemical & Process Eng
Module Delivered in: 1 programme(s)
Module Description: This module addresses quality, validation, and risk management aspects of New Product Introduction technology transfer in biopharmaceutical & pharmaceutical manufacturing environments factoring in environmental sustainability as a key topic.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Implement quality by design & control strategies for new product introductions in pharmaceutical science.
LO2 Appraise the change management process in terms of execution, evaluation, governance and management oversite.
LO3 Critically examine a paperless validation software package as used during the process of new product introduction to enhance environmental sustainability and efficiency.
LO4 Formulate a systematic understanding of pharmaceutical regulatory affairs requirements and strategy relevant to new product introductions.
LO5 Compare technology transfer relevant case studies with a view to communicating to one’s peers.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Quality by Design & Control Strategy:
Documentation management & technical writing in a GMP environment. Pharmaceutical quality system, ICH Q8 R2, ICH Q9, ICH Q10, ICH Q11, ICH Q12. Quality risk management during NPI. Product critical quality attributes, analytical comparability/similarity and stability strategy, process validation/process performance qualification strategy, regulatory filings & site manufacturing site licenses. Process analytical technology (PAT), Process capability and product variability, knowledge management. Process performance and product quality monitoring system.
Regulatory Concepts:
Regulatory strategy & requirements, regulatory requirements versus target market, Drug regulation, Agencies e.g. FDA, HPRA. classification, regulatory structure, EU market submission pathways.
Change Management:
Change management documentation & current software. change/scope identification, change rationale, impact/level, and risk, change plan/execution, post-change evaluation, change management metrics, governance, management oversight, and change management prioritization.
Process validation:
Process validation lifecycle, Qualification, verification, validation batches, Inter-batch variability assessment, Dissolution, Periodic Review & Revalidation, Contract Manufacturing.
Cleaning validation:
Cleaning regulations, cleaning validation a risk approach, cleaning validation principles, cleaning methodologies, application of the principles of sustainability, acceptance criteria.
Paperless validation:
Application of a paperless validation software package such as KNEAT to the process of implementing a new piece of equipment into a GMP setting. Paperless validation in automation of process equipment & recipes.
Quality risk management:
Data integrity, ALCOA and ALCOA+, data life cycle, GxP computerised system life cycle, data governance life cycle, FDA 21 CFR Part 11, risk assessment, risk identification, risk analysis, risk evaluation, risk control, risk reduction, risk acceptance, risk management tools FMEA (failure modes effects analysis)/FMEACA (failure modes effects criticality analysis) and HAACCP (hazard analysis and critical control point), risk review, risk communication. Critical process parameters, Critical quality attributes, Cross contamination, containment, safety, ICH Q9 quality risk management. Good automated manufacturing practise (GAMP)
Corrective Action & Preventative Action (CAPA) System:
Quality management framework, corrective and/or preventative actions (CAPA) governance, CAPA documentation, CAPA effectiveness, CAPA metrics, root cause identification, management oversight, and CAPA prioritization.
Case Studies:
• Biologics tech transfer quality and risk review with a CMO. • Small molecule global API technology transfer quality and risk review. • ICH Q10 product lifecycle case study: technology transfer.
Module Content & Assessment
Assessment Breakdown%
Coursework100.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 20
Timing Week 6 Learning Outcomes 1,2
Assessment Description
In-class assessment: Quality by design & control strategies and change management process
Assessment Type Presentation % of Total Mark 40
Timing Week 9 Learning Outcomes 4,5
Assessment Description
Presentation: Critique assigned NPI case study & include focus on regulatory affairs requirements & strategies
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Timing Week 13 Learning Outcomes 3
Assessment Description
Paperless validation virtual laboratory: Attend, complete and execute assigned laboratory activities and write ups.
No End of Module Formal Examination
Reassessment Requirement
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Any guest lectures will be arranged based on industry expert's availability and at the beginning of each semester where possible. Assigned module lecturers will advise accordingly regarding guest lecturers & schedule. Every Week 3.00 3
Lab Contact Paperless validation laboratory Every Week 1.00 1
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material and preparation of reports for selected laboratory sessions and in-class topics. Every Week 10.00 10
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 4.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Theory on course topics and discussion of industry relevant examples. Any guest lectures will be arranged based on industry expert's availability and at the beginning of each semester where possible. Assigned module lecturers will advise accordingly regarding guest lecturers & schedule. Every Week 3.00 3
Lab Contact Paperless Validation lab Every Week 1.00 1
Independent & Directed Learning (Non-contact) Non Contact Review of lecture notes and recommended material and preparation of reports for selected laboratory sessions and in-class topics. Every Week 10.00 10
Total Hours 14.00
Total Weekly Learner Workload 14.00
Total Weekly Contact Hours 4.00
 
Module Resources
Recommended Book Resources
  • Richard C. DORF,David L. Goetsch,Stanley Davis. Quality Management for Organizational Excellence- Introduction to Total Quality, [ISBN: 9781292022338].
  • B.P. Nagori, A. Gaur, R. Solanki and V. Mathur. (2023), Pharmaceutical Quality Assurance, 3rd. Scientific Publishers, Jodhpur, [ISBN: 9789386652010].
  • Bhusari, K. P., Shivhare, U., D., Goupale, D. C.,. (2014), Pharmaceutical Quality Assurance and Management, PharmaMed Press, Hyderabad, [ISBN: 9788178002767].
Supplementary Book Resources
  • ISPE. (2017), ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products, ISPE.
  • ISPE. (2022), ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd. ISPE.
  • ISPE. (2018), ISPE GAMP RDI Good Practice Guide Data Integrity – Key Concepts..
  • ISPE. (2019), ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation., ISPE.
  • ISPE. ISPE Part 1 – Product Quality Lifecycle Implementation Guide: Product Realization.
  • ISPE. ISPE Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example..
  • ISPE. ISPE Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System..
  • ISPE. ISPE Part 4 – Process Performance and Product Quality Monitoring System.
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ERNPI_9 Master of Science in Regulated New Product Introduction & Technology Transfer 1 Mandatory