Current Academic Year 2024 - 2025
All Module information is indicative, and this portal is an interim interface pending the full upgrade of Coursebuilder and subsequent integration to the new DCU Student Information System (DCU Key).
As such, this is a point in time view of data which will be refreshed periodically. Some fields/data may not yet be available pending the completion of the full Coursebuilder upgrade and integration project. We will post status updates as they become available. Thank you for your patience and understanding.
Date posted: September 2024
| Module Title |
Biopharmaceutical Industry Regulation & Management |
| Module Code |
BE418 (ITS) / BTE1018 (Banner) |
|
Faculty |
Science & Health |
School |
Biotechnology |
| Module Co-ordinator | Denis Collins | | | Module Teachers | Brian Freeland, Denise Harold, Linda Holland, Paul Cahill, Paula Meleady | |
|
NFQ level |
8 |
Credit Rating |
5 |
|
Pre-requisite |
Not Available |
|
Co-requisite |
Not Available |
| Compatibles |
Not Available |
| Incompatibles |
Not Available |
|
None
|
Description
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. 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 |
| Lecture | 16 | No Description | | Independent Study | 109 | No 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
|
| Assessment Breakdown | | Continuous Assessment | 50% | Examination Weight | 50% |
| Course Work Breakdown |
| Type | Description | % of total | Assessment Date |
|---|
| Assignment | n/a | 50% | n/a |
| Reassessment Requirement Type |
Resit arrangements are explained by the following categories:
Resit category 1: A resit is available for both* components of the module.
Resit category 2: No resit is available for a 100% continuous assessment module.
Resit category 3: No resit is available for the continuous assessment component where there is a continuous assessment and examination element. |
| * ‘Both’ is used in the context of the module having a Continuous Assessment/Examination split; where the module is 100% continuous assessment, there will also be a resit of the assessment |
| This module is category 1 |
|
Indicative Reading List
- ISPE: 2004, ISPE Baseline® Pharamceutical Engineering Guides for New and Renovated Facilities, Biopharmaceutical Manufacturing Facilities (Part I of III), Volume 6, 64007,
- Blackwell publishing Ltd: 2005, Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries, (Hardcover) Blackwell publishing Ltd, 64008,
- Imperial College Press: 2004, Bioanalytical Chemistry, Imperial College Press, London,,
|
Other Resources
None |
|
|
