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Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title Biopharmaceutical Industry Regulation & Mgt
Module Code BE583
School School of Biotechnology
Module Co-ordinatorSemester 1: Damien King
Semester 2: Damien King
Autumn: Damien King
Module TeachersPaul Cahill
Brian Freeland
John Milne
Denise Harold
David Collins
Damien King
NFQ level 9 Credit Rating 5
Pre-requisite None
Co-requisite None
Compatibles None
Incompatibles None

1. Module Aims: This module will provide a high level overview of the regulatory environment and the roles and responsibilities in which biopharmaceutical engineering professionals must operate. The focus will be on the increasing regulatory needs throughout the development lifecycle. A review of current good manufacturing practices (c GMP) associated with the manufacture of biological medicinal products for human use shall be undertaken and this shall be applied to the students own organisation and a gap analysis completed. As the landscape is driving for regulatory harmonisation emphasis on commonality and unique regional requirements shall be investigated. The entire value system of Regulatory importance shall be covered namely, the Institute for Chemical Harmonisation Guidance on Quality Systems ICH Qx, which addresses all current best practice aspects of Biopharmaceutical quality management This shall focus on Utilities, manufacturing and Quality test and release of products as required by regulation. 2. The module will take both a current and prospective look at the ever evolving regulatory requirements, applying the principles of quality by design and continuous improvements during biopharmaceutical development facilitate using a range of risk management tools, thereby building innovation into a proposed manufacturing process. This approach is based on the FDA’s initiative of cGMPs for the 21st Century. Process validation considerations for biopharmaceutical manufacturing will also be addressed, in terms of the process and quality attributes considered to be critical. A sound Quality system shall be designed using best practice from across the guidelines to act as a template for comparison to existing quality systems within the students organisation. As a focal point the role of Bioanalytical methodologies shall be investigated and the challenges associated with the validation and regulatory approval of Bioanalytical methods shall be explored.

Learning Outcomes

1. Define a best practice quality system for a biopharmaceutical manufacturing operation, understand where their own organisation fits relative to established best practice and be able to make recommendations to improve their own quality system and mitigate risk during site inspections.
2. Demonstrate an understanding of the drivers for regulation within the industry and to use basic project management tools to assist in risk mitigation studies of their own organisations
3. Outline procedures for managing compliance based on the cGMPs for the 21st Century initiative

Workload Full-time hours per semester
Type Hours Description
Lecture16No Description
Independent Study109No Description
Total Workload: 125

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Introduction to Regulatory Affairs & Quality Systems

The evolution of cGMP in Pharmaceutical Production

ICH Guidelines and their implications for operations

Quality by Design – Theory and Practice

The drug development cycle and the increased need for Regulation

Best Practice Internal Quality Management

Corrective Actions Vs Preventative Actions

Product Quality attributes – the importance of Structure and Function in Biopharmaceuticals

The challenges for Bioanalytics for process control

Assessment Breakdown
Continuous Assessment100% Examination Weight0%
Course Work Breakdown
TypeDescription% of totalAssessment Date
AssignmentWritten Assignment100%
Reassessment Requirement Type
Resit arrangements are explained by the following categories;
1 = A resit is available for all components of the module
2 = No resit is available for 100% continuous assessment module
3 = No resit is available for the continuous assessment component
This module is category 1
Indicative Reading List

  • 2004: ISPE Baseline® Pharamceutical Engineering Guides for New and Renovated Facilities, Biopharmaceutical Manufacturing Facilities (Part I of III), Volume 6, 191603
  • 2005: Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, (Hardcover) Blackwell publishing Ltd, 191604
  • 2004: Bioanalytical Chemistry, Imperial College Press, London,
Other Resources

36445, Guidelines, 0, ICH Guidelines Q6a, Q7, Q8, Q9, Q10, Q11, 36446, Guidelines, 0, EMEA Guidelines on comparibility,
Programme or List of Programmes
CHPMMaster of Science
GCBEGraduate Cert in Bioprocess Engineering
GDBEGraduate Dip in Bioprocess Engineering
MSBEMSc in Bioprocess Engineering
PYPMMaster of Science
SMPSCSingle Module Prof. Science and Health
Date of Last Revision10-MAR-11

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