PHRM07014 2019 PHARMACEUTICAL QUALITY SYSTEMS

General Details

Full Title
PHARMACEUTICAL QUALITY SYSTEMS
Transcript Title
PHARMACEUTICAL QUALITY SYSTEMS
Code
PHRM07014
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Colin Fowley
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science
Description

This module will demonstrate the importance of the systems approach both to quality and manufacturing within the highly regulated pharmaceutical sector.  systems such as ISO 9000:2015 and ISO17025:2017 will be examined and topics such as document and product traceability will be analysed.

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 9000:2015 and ISO17025:2017 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.

Teaching and Learning Strategies

This module will be dilivered fulltime. This will include lectures augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as ameans of assesmnet. 

Module Assessment Strategies

This module is 100% Continous Assesment 

Repeat Assessments

Repeat Continous Assesment 

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

​​​​​​1.Evaluate the development and importance of Quality System Standards.

The development of the concept of quality and quality systems.

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

2. Identify the principal requirements of a Quality System.

Quality Management Systems : implementations and benefits.

Quality System requirements - ISO9000 :2015 and ISO 17025:2017.

 

3. Evaluate the benefits of the ISO 9000:2015 and ISO17025:2017 Quality Systems.

Quality Management Systems : implementations and benefits.

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

Documentation and Documentation Change Control - quality records.

The Quality Manual - Contents and structure.

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

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

Principals of Validation, system, product, equipment etc. 

 

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 CA 1 MCQ Continuous Assessment Multiple Choice 15 % Start of Semester 1,2
2 Presentation Formative Performance Evaluation - % Any 2,3
3 MCQ & SAQ Continuous Assessment Multiple Choice 15 % Week 9 1,2,3
4 Technical Report Continuous Assessment Project 35 % Week 11 4,5
5 Focus on Standardization Continuous Assessment Written Report 20 % Week 12 3,4,5

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Tiered Classroom Lecture 3 Weekly 3.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

ISO9001 2015 

ISO17025 2017

Other Resources

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7

Additional Information

N/A