| CODE | PHR2608 | ||||||||||||
| TITLE | Active Pharmaceutical Ingredients Manufacture | ||||||||||||
| UM LEVEL | 02 - Years 2, 3 in Modular Undergraduate Course | ||||||||||||
| MQF LEVEL | 5 | ||||||||||||
| ECTS CREDITS | 4 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | - Designing Active Pharmaceutical Ingredients (APIs) - Active pharmaceutical ingredients manufacture - Green active pharmaceutical ingredients manufacture - Quality testing of APIs - cGMP and FDA requirements in API manufacture - Sterile APIs - Biologicals manufacture Visits to a pharmaceutical plant. Study-unit Aims: - To describe processes and controls essential in the manufacture of APIs. - To present the regulatory framework required in the manufacture of APIs. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - describe standards required in the manufacture and use of APIs; - illustrate an understanding of processes required in the manufacture and use of APIs. 2. Skills By the end of the study-unit the student will be able to: - follow processes required in the synthesis and analysis of APIs; - list requirements of cGMP in the manufacture and acquisition of APIs; - present information on synthesis of APIs in scientific manner, with the appropriate referencing system. Main Text/s and any supplementary readings: - Sharp J. Quality rules in active pharmaceutical ingredients manufacture. Florida: CRC Press LLC; 2000. - Nusim SH, editor. Active pharmaceutical ingredients: Development, manufacturing and regulation. 2nd ed. New York: Informa Healthcare; 2010. |
||||||||||||
| STUDY-UNIT TYPE | Lecture | ||||||||||||
| METHOD OF ASSESSMENT |
|
||||||||||||
| LECTURER/S | Nicolette Sammut Bartolo |
||||||||||||
|
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 Units not attracting a sufficient number of registrations may be withdrawn without notice.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. |
|||||||||||||