PHRM07022 2020 PHARMACEUTICAL QUALITY SYSTEMS

General Details

Full Title
PHARMACEUTICAL QUALITY SYSTEMS
Transcript Title
PHARMACEUTICAL QUALITY SYSTEMS
Code
PHRM07022
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
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Colin Fowley
Programme Membership
SG_SPHAD_B07 201900 Bachelor of Science 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, ISO17025 and the ICH guideline on pharmaceutical quality systems 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, ISO17025 and the ICH Q10 Quality System guideline.

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 delivered online. This will include live and prerecorded 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 a means of assessment. 

Module Assessment Strategies

This module is 100% Continuos Assessment 

Repeat Assessments

Repeat Continuos Assessment 

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 and ISO 17025.

 

3. Evaluate the benefits of the ISO 9000 and ISO17025 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 20 % Start of Semester 1,2
2 MCQ & SAQ Continuous Assessment Multiple Choice 20 % Week 9 1,2,3
3 Technical Report Continuous Assessment Project 40 % Week 11 4,5
4 Focus on Standardization Continuous Assessment Written Report 20 % Week 12 3,4,5

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Module Resources

Non ISBN Literary Resources

ISO9001

ISO17025

ISO07045

ICH Q10 

Other Resources

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7

Additional Information

N/A