Study-Unit Description

Study-Unit Description


CODE PHR5005

 
TITLE Industrial Pharmacy

 
LEVEL 05 - Postgraduate Modular Diploma or Degree Course

 
ECTS CREDITS 5

 
DEPARTMENT Pharmacy

 
DESCRIPTION The unit covers aspects of industrial pharmacy related to process and systems review within development, production, testing and distribution of medicinal products settings. Aspects of accreditation, elaboration and maintenance of quality systems, principles of quality control and quality assurance are presented. The unit presents information on principles of microbiology as they impact on pharmaceutical and healthcare products. Processes to protect patients and consumers from exposure of contaminated products are explored.

Reflections on meeting occupation health and safety requirements and contributing to robust and practical engineering pharmaceutical systems are put forward.

Study-Unit Aims:

- To review the approach and implementation of regulations and guidelines in industrial pharmacy processes related to the development, manufacture, testing and distribution of medicinal products;
- To discuss actions and risk mitigation strategies to reduce bioburden and microbial contamination in pharmaceutical processes.

Learning Outcomes:

1. Knowledge and Understanding:

- Describe methods of accreditation relevant to pharmaceutical industry settings;
- Identify opportunities for pharmaceutical contribution in the elaboration of pharmaceutical engineering processes required for the production and distribution of medicinal products;
- Appreciate occupational health and safety requirements in developing pharmaceutical processes for production and testing of medicinal products.
- Applications of pharmaceutical microbiology in pharmaceutical processes including GMP and GDP practice.

2. Skills:

- Develop and maintain quality systems;
- Monitor and evaluate operations and processes related to activities in the pharmaceutical industry;
- Estimate financial, resource and time requirements for pharmaceutical processes;
- Handling day-to-day running of production, quality control, quality assurance, and distribution activities for medicinal products.
- Devise processes that control microbial contamination and develop remediation strategies within GMP and GDP facilities.

Reading List:

- Felton L. Remington: Essentials of Pharmaceutics. London: Pharmaceutical Press. 2013.
- Mohan P, Glassey J, Montague GA. Pharmaceutical Operations Management. USA: McGraw Hill. 2006.
- Rang HP. Drug Discovery and Development. USA: Churchill Livingstone. 2006.

Supplementary:

- Futschik M. Electronic Batch recording solutions. Springer Vieweg. 2017.
- Reklaitis GV, Seymour C, Garcìa-Munoz S. Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture. Wiley-AIChE. 2017.

 
STUDY-UNIT TYPE Lecture

 
METHOD OF ASSESSMENT
Assessment Component/s Assessment Due Resit Availability Weighting
Examination (2 Hours) See note below Yes 100%
Note: Assessment due date will be notified by the Faculty/Institute/Centre/School.

 
LECTURER/S Lilian M. Azzopardi
Anthony Serracino Inglott
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