Module Details

Module Code: PHAR S8024
Full Title: Validation and Instrumentation
Valid From:: Semester 1 - 2020/21 ( September 2020 )
Language of Instruction:English
Duration: 1 Semester
Credits:: 5
Module Owner:: Arjan van Rossum
Departments: Life and Health Sciences
Module Description: This module introduces the learner to the principles of validation and risk management and the application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the biopharmaceutical industry.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Illustrate the need for validation and explain how it complements good manufacturing practice.
MLO2 Examine the regulatory requirements of validation.
MLO3 Assess the principles of validation and a range of strategies used in its application.
MLO4 Evaluate the various process development considerations for the full scale manufacture of biopharmaceuticals.
MLO5 Develop suitable validation approaches to achieve process validation over the product lifecycle.
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 DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Validation Principles, Regulations and Model
EU and FDA regulations and guidelines. V-Model, introduction to the understanding-demonstration-monitoring approach, Quality by design, Industrial standard ASTM E2500-07. Risk management, industrially recognised risk management guidelines and tools, risk registers.
Process Validation
Biopharmaceutical process unit operations, Process validation workflow, and process validation prerequisites, Process validation studies: viral clearance, impurity clearance, process consistency, process intermediate stability, process solution stability, drug substance fill/freeze/thaw/storage, mixing studies and chromatography resin and reusable membrane lifetime validation. Commissioning and qualification of processes and utilities. Process Performance Qualification, Continued Process Verification, Cleaning Validation/Verification. Prospective, concurrent and retrospective approaches in process validation. Revalidation. Review of the steps to prove that analytical methods are fit for purpose with reference to current guidelines.
Documentation
Preparation and review of validation documents such as the User Requirement Specification, Validation Master Plan, Validation Protocol, Validation Report.
Instrumentation
Overview of equipment and instrumentation for validation/biopharm manufacturing.
Module Assessment
Assessment Breakdown%
Course Work50.00%
Final Examination50.00%
Module Special Regulation
 

Assessments

Part-time

Course Work
Assessment Type Written Report % of Total Mark 40
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 5
Duration in minutes 0
Assessment Description
Prepare a validation document which sets
out suitable validation approaches to
achieve process validation over the product
lifecycle.
Assessment Type Continuous Assessment % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing n/a Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
In class assessment.
No Project
No Practical
Final Examination
Assessment Type Formal Exam % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
n/a
Reassessment Requirement
A 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.

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

This module has no Full-time workload.
Workload: Part-time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Lecture / tutorial / discussion as appropriate Every Week 2.00 2
Independent Study Non Contact Independent study Every Week 3.00 3
Directed Reading Non Contact Directed reading Every Week 3.00 3
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 2.00
 
Module Resources
Recommended Book Resources
  • Robert A. Nash,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, CRC Press, [ISBN: 978-1-43-9850].
  • Walkiria S. Schlindwein,Mark Gibson. (2018), Pharmaceutical Quality by Design, John Wiley & Sons, [ISBN: 1118895207].
  • Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe. (2015), Quality by Design for Biopharmaceutical Drug Product Development, Springer, [ISBN: 1493923161].
This module does not have any article/paper resources
Other Resources