|LEVEL||05 - Postgraduate Modular Diploma or Degree Course|
|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.
- 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.
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.
- 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.
- 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.
- Futschik M. Electronic Batch recording solutions. Springer Vieweg. 2017.
- Reklaitis GV, Seymour C, GarcÃ¬a-Munoz S. Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture. Wiley-AIChE. 2017.
|METHOD OF ASSESSMENT||
|LECTURER/S||Lilian M. Azzopardi
Anthony Serracino Inglott
Maurice Zarb Adami
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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.