QUAL07001 2008 PHARMACEUTICAL QUALITY SYSTEMS

General Details

Full Title
PHARMACEUTICAL QUALITY SYSTEMS
Transcript Title
PHARMACEUTICAL QUALITY SYSTEM
Code
QUAL07001
Attendance
N/A %
Subject Area
QUAL - Quality Control
Department
ASCI - Applied Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2008 - Full Academic Year 2008-09
End Term
2019 - Full Academic Year 2019-20
Author(s)
Declan Shelly
Programme Membership
SG_SPHAR_B07 201000 Bachelor of 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 9000:2005 and ISO17025:2005 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 9000:2005 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 requirements of a Quality Manual.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

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.

Quality System requirements - ISO9000 :2005 and ISO 17025:2005.

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).

Principals of Validation, system, product, equipment etc. 

The Quality Manual - Contents and structure.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Question and Answer sessions. Computer aided self assessment. Formative UNKNOWN - % OnGoing 1,2,3,4,5,6
2 Written assessment -
Multiple choice questions. Short answer questions.
Continuous Assessment UNKNOWN 40 % OnGoing 1,2,3,4,5,6
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Written exam. Final Exam UNKNOWN 60 % End of Term 1,2,3,4,5,6
             
             

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
None
Other Resources

Module Lecture Notes.