Study-Unit Description

Study-Unit Description


CODE PHR3606

 
TITLE Pharmaceutical Quality Assurance

 
LEVEL 03 - Years 2, 3, 4 in Modular Undergraduate Course

 
ECTS CREDITS 6

 
DEPARTMENT Pharmacy

 
DESCRIPTION PHARMACEUTICAL REGULATION
- Quality as an important component in regulation
- The concept of quality assurance and its inter-relationship with GMP and quality control

COMPLIANCE TO QUALITY ASSURANCE:
- Training of personnel
- Calibration and Maintenance
- Cleaning and environmental control
- Standard Operating Procedures
- Documentation
- Audits
- Validation

THE IMPORTANCE OF DOCUMENTATION:
- Recording
- Documentation review
- Documents and laboratory records
- Out of specification results

FUTURE TRENDS:
- Quality assurance responsibilities.


Study-unit Aims

This study units aims to indicate the importance and applicability of quality assurance in various areas of the field of pharmaceutical technology particularly in the pharmaceutical industry.


Learning Outcomes

1. Knowledge & Understanding: By the end of the study-unit the student will be able to:

- Appreciate the importance and implications of quality assurance.

2. Skills: By the end of the study-unit the student will be able to:

- Follow various required models of quality assurance.
- Apply required steps to ensure maintenance of good quality in practical settings.


Main Text/s and any supplementary readings

- Beaney A.M. Quality Assurance of Aseptic Preparation Services 4th edn., London: Pharmaceutical Press, 2006.
- MHRA. Rules and Guidance for Pharmaceutical manufacturers and distributors 2007, London: Pharmaceutical Press, 2007.
- Sharp J. Quality in the Manufacture of Medicines and other Healthcare products, London: Pharmaceutical Press, 2000.

 
RULES/CONDITIONS Before TAKING THIS UNIT YOU MUST TAKE PHR2604

 
STUDY-UNIT TYPE Lecture

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Resit Availability Weighting
Online Examination (3 Hours) SEM2 Yes 100%

 
LECTURER/S Dustin Balzan
Maurice Zarb Adami

 
The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2020/1. It may be subject to change in subsequent years.

https://www.um.edu.mt/course/studyunit