| CODE | PHR5031 | ||||||||||||||||
| TITLE | Qualified Person Requirements: Pharmaceutical Technology | ||||||||||||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||||||||||||
| MQF LEVEL | 7 | ||||||||||||||||
| ECTS CREDITS | 5 | ||||||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||||||
| DESCRIPTION | The study-unit presents the pharmaceutical technology area required to be covered by candidates aspiring to seek approval to practice as a Qualified Person in the pharmaceutical industry. From a gap analysis to an identification of the areas required, the unit addresses the compulsory issues required for a Qualified Person. Study-unit Aims: To present areas related to medicinal product development and production as related to activities undertaken by Qualified Persons as prescribed in the EU Directive 2001/83/EC. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: • Select adequate pharmaceutical processes for specific manufacture of pharmaceutical preparations within a GMP setting; • Identify pharmaceutical principles relevant for the evaluation of processes developed for the manufacture of investigative medicinal products and medicinal products according to approved marketing authorisation. 2. Skills: By the end of the study-unit the student will be able to: • Apply principles and requirements of Good Manufacturing Practice to practical scenarios in processes undertaken within the pharmaceutical industry; • Carry out batch release of medicinal products and investigational medicinal products to the European Market or for clinical trials. Main Text/s and any supplementary readings: Ausberger LL, Hoag SW, editors. Pharmaceutical dosage forms: Tablets. 3rd ed. New York: Informa Healthcare; 2008. |
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| STUDY-UNIT TYPE | Lecture | ||||||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Nicolette Sammut Bartolo Edwina V. Brejza |
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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 2024/5. It may be subject to change in subsequent years. |
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