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MANU7007 - Validation Science

Title:Validation Science
Long Title:Validation Science
Module Code:MANU7007
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Manufacturing Engineering
Valid From: Semester 1 - 2022/23 ( September 2022 )
Module Delivered in 5 programme(s)
Module Coordinator: Michael J. OMahony
Module Author: Caroline OSullivan
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:
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.
Pre-requisite learning
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

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

Module Content & Assessment

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, Validation Report.
Assessment Breakdown%
Course Work100.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Multiple Choice Questions Midterm Assessment 1,2,3 30.0 Week 5
Practical/Skills Evaluation Group Project 1,3,4,5 40.0 Week 10
Open-book Examination End of Term Assessment 3,4,5 30.0 Week 13
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 institute reserves the right to alter the nature and timings of assessment


Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.5 Every Week 2.50
Lecturer-Supervised Learning (Contact) Project/Assignment 1.0 Every Second Week 0.50
Independent & Directed Learning (Non-contact) Student Study 4.0 Every Week 4.00
Total Hours 7.50
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Introduction to module, case studies and conclusions 3.75 Twice per semester 0.50
Directed Learning Online recorded presentations, notes and other materials, 10 hours spread over the semester 10.0 Once per semester 0.67
Lecturer-Supervised Learning (Contact) 4 x 3 hour workshops 3.0 Every Third Week 1.00
Directed Learning 4 x 1 hour industry webinars 1.0 Every Second Week 0.50
Lecturer-Supervised Learning (Contact) Mentoring 1.0 Every Week 1.00
Independent & Directed Learning (Non-contact) Private Study 3.33 Every Week 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 and Alfred H. Wachter 2003, Pharmaceutical Process Validation, Marcel Dekker [ISBN: 0-8247-0838-5]
  • Anurag S. Rathore and Gail Sofer (Editors) 2012, Process Validation in Manufacturing of Biopharmaceuticals, 3rd Ed., CRC Press [ISBN: 978-1-43-985093-0]
  • Walkiria S. Schlindwein and Mark Gibson (Editors) 2018, Pharmaceutical Quality by Design: A Practical Approach, 1st Ed., John Wiley & Sons [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]
Supplementary Book Resources
  • ISPE 2001, Pharmaceutical Engineering Guides for New and Renovated Facilities, commissioning and qualification, published [ISBN: ISBN 1-931879-06-0]
  • John Sharp 2004, Good Pharmaceutical Manufacturing Practices, Rationale and Compliance, Interpharm/CRC [ISBN: 0849319943]
  • ISPE 2008, The GAMP Guide for Validation of Automated Systems [ISBN: 1931879613]
  • ISPE 2004, Pharmaceutical Engineering Guides for New and Renovated Facilities: Biopharmaceutical Manufacturing Facilities, 1st Ed., ISPE [ISBN: 1931879095]
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 Elective
CR_SBIBI_7 Bachelor of Science in Applied Biosciences and Biotechnology 5 Elective
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 2 Mandatory
CR_SVASC_7 Certificate in Validation Science 2 Mandatory

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