Module Details

Module Code: MANU7007
Title: Validation Science
Long Title: Validation Science
NFQ Level: Intermediate
Valid From: Semester 1 - 2024/25 ( September 2024 )
Duration: 1 Semester
Credits: 5
Field of Study: 5400 - Manufacturing Engineering
Module Delivered in: 5 programme(s)
Module Description: This module gives the learner a broad understanding of the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical, biopharmaceutical and medical device industries. The use of risk assessment techniques in validation is explained.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Discuss and illustrate the need for validation and explain how it complements good manufacturing practice.
LO2 Examine the regulatory requirements of validation, identify and discuss the industry standard guidelines in use.
LO3 Assess the principles of validation and a range of strategies used in its application.
LO4 Apply a range of risk management tools in making regulatory based decisions.
LO5 Prepare a validation document, e.g. a validation protocol or report, in accordance with regulatory requirements.
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).
20328 MANU7007 Validation Science
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
Validation Lifecycle
EU and FDA regulations and guidelines. V-Model, introduction to the understanding-demonstration-monitoring approach.
Process Validation
Quality by design, establishing a strategy for process control. Commissioning and qualification of processes and utilities. Process Performance Qualification, Continued Process Verification. Prospective, concurrent and retrospective approaches in process validation. Revalidation.
Risk Management in Process Validation
Review of industrially recognised risk management guidelines and application of tools such as PHA, FMECA and Fault Tree Analysis.
Validation of Pharmaceuticals and Biopharmaceuticals
Validation of APIs, solid dosage forms, inhalation aerosols. Sterilisation and aseptic process validation.
Validation of Medical Devices
Lifecycle approach to validation with a focus on medical devices. Validation vs. verification. Validation of software controlling a medical device.
Analytical Method Validation
Review of the steps to prove that analytical methods are fit for purpose with reference to current guidelines.
Computer and Automation Validation
Compliance with 21 CFR Part 11 and use of GAMP guidelines. Confirmation of data integrity.
Cleaning Validation
Methodologies used to prove the effectiveness of equipment cleaning processes and procedures in the manufacturing process.
Validation Documentation
Preparation and review of validation documents such as the User Requirement Specification, Validation Master Plan, Validation Protocol, and Validation Report. Paperless Validation.
Module Content & Assessment
Assessment Breakdown%
Coursework100.00%

Assessments

Coursework
Assessment Type Multiple Choice Questions % of Total Mark 30
Timing Week 5 Learning Outcomes 1,2,3
Assessment Description
Midterm Assessment
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Timing Week 10 Learning Outcomes 1,3,4,5
Assessment Description
Group Project
Assessment Type Short Answer Questions % of Total Mark 30
Timing Week 13 Learning Outcomes 3,4,5
Assessment Description
End of Term Assessment
No End of Module Formal Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

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 Classroom Instruction Every Week 2.50 2.5
Lecturer-Supervised Learning (Contact) Contact Project/Assignment Every Second Week 0.50 1
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 4.00 4
Total Hours 7.50
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Introduction to module, case studies and conclusions Twice per semester 0.50 3.75
Directed Learning Non Contact Online recorded presentations, notes and other materials, 10 hours spread over the semester Once per semester 0.67 10
Lecturer-Supervised Learning (Contact) Contact 4 x 3 hour workshops Every Third Week 1.00 3
Directed Learning Non Contact 4 x 1 hour industry webinars Every Second Week 0.50 1
Lecturer-Supervised Learning (Contact) Contact Mentoring Every Week 1.00 1
Independent & Directed Learning (Non-contact) Non Contact Private Study Every Week 3.33 3.33
Total Hours 22.08
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 2.50
 
Module Resources
Recommended Book Resources
  • Robert A. Nash,Alfred H. Wachter. (2003), Pharmaceutical Process Validation, CRC Press, p.776, [ISBN: 0-8247-0838-5].
  • Anurag S. Rathore and Gail Sofer (Editors). (2012), Process Validation in Manufacturing of Biopharmaceuticals, 3rd. CRC Press, [ISBN: 978-1-43-985093-0].
  • Walkiria S. Schlindwein, Mark Gibson. (2018), Pharmaceutical Quality by Design, 1st Edition. John Wiley & Sons, p.375, [ISBN: 1118895207].
  • Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe (Editors). (2015), Quality by Design for Biopharmaceutical Drug Product Development, Springer, [ISBN: 1493923161].
  • ISPE. (2023), ISPE 2023, ISPE Baseline® Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities, 3rd Edition.
  • ISPE. (2020), ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls, 1st Edition.
  • ISPE. (2019), ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation, 1st Edition.
  • ISPE. (2019), Baseline Guide Vol 5: Commissioning & Qualification, 2nd Edition.
Supplementary Book Resources
  • John Sharp. (2004), Good Pharmaceutical Manufacturing Practices, Rationale and Compliance, Interpharm/CRC, [ISBN: 0849319943].
  • ISPE. (2022), ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd Edition.
  • ISPE. (2014), ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems, 2nd Edition.
  • ISPE. (2018), Baseline Guide Vol 3: Sterile Product Manufacturing Facilities, 2nd Edition.
  • ISPE. (2017), ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products, 2nd Edition.
  • ISPE. (2011), PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles.
  • ISPE. (2011), PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example, 1st Edition.
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ECPEN_8 Bachelor of Engineering (Honours) in Chemical and Biopharmaceutical Engineering 3 Elective
CR_SPHBI_8 Bachelor of Science (Honours) in Pharmaceutical Biotechnology 5 Mandatory
CR_SBIBI_7 Bachelor of Science in Applied Biosciences and Biotechnology 5 Mandatory
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 2 Mandatory
CR_SVASC_7 Certificate in Validation Science 2 Mandatory