Full Title BioPharmaceutical Quality Systems

Short Title BioPharma Q Systems

Code BIO07030
Level 07
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Bio Tech/Eng/Chem
Attendence N/A%
Fee

Description
This module will demonstrate the importance of the systems approach both to quality and manufacturing

within the highly regulated biopharmaceutical sector.

Indicative Syllabus
The development of the concept of quality and quality systems.

Assessment of the cost of quality, prevention costs, appraisal costs, failure costs.

Quality Management Systems : implementations and benefits, Regulatory bodies, Eudralex, ICH guidance docs

Quality System requirements ISO9000 :2005/ ISO 9001:2008, ICH Q 09 and Q10

Documentation and Documentation Change Control quality records.

Auditing, types of audit, non conformances and corrective action, the importance of self inspection.

Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP)/ ISO 17025

Principals of Validation, system, product, equipment etc.


Learning Outcomes
On completion of this module the learner will/should be able to
  1. Evaluate the development and importance of Quality System Standards.

  2. Identify the principal requirements of a Quality System.

  3. Evaluate the benefits of the ISO 9000:2005 and ISO17025:2005 Quality Systems

  4. Illustrate the importance of documentation as required by a Quality System.

  5. Discuss the importance of Good Manufacturing Practice in a regulated environment

  6. Describe the main contents of a Quality Manual.


Assessment Strategies
The assessment approach for this module will be 60% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ

Assessment Facilitites
None

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 60 %
End of Semester / Year Formal Examination 40 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
CA 1,2,3,4,5,6 60 OnGoing


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Final exam 1,2,3,4,5,6 40 End of Semester


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Lecture Online Online delivery 2 Weekly 2.00
Tutorial Online tutorial 1 Weekly 1.00

Total Average Weekly Learner Workload 3.00 Hours

Resources
Book Resources

Other Resources
Url Resources
ISO guidelines, ICH guidelines
Additional Info