| CODE | PHR3605 | ||||||||
| TITLE | Pharmaceutical Validation | ||||||||
| UM LEVEL | 03 - Years 2, 3, 4 in Modular Undergraduate Course | ||||||||
| MQF LEVEL | 6 | ||||||||
| ECTS CREDITS | 4 | ||||||||
| DEPARTMENT | Pharmacy | ||||||||
| DESCRIPTION | This study-unit will incorporate the background, value and extent of validation as well as the application of validation in different aspects of the manufacturing process. Relevance of process validation, cleaning validation and qualification as a means to contribute to medicinal product quality and safety. Aspects of analytical method validation, documentation are presented. The management of an HVAC and water system within the pharmaceutical industry is considered. Study-unit Aims: - To identify the need of validation; - To establish concepts of validation in the pharmaceutical industry; - To identify the validation processes for different pharmaceutical processes. Learning Outcomes: 1. Knowledge & Understanding By the end of the study-unit the student will be able to: - List steps in validation; - Describe scenarios where validation is necessary. 2. Skills By the end of the study-unit the student will be able to: - Develop protocols for validation of processes within the pharmaceutical industry; - Maintain documentation required; - Perform validation of analytical assays and test methods; - Support in pharmaceutical process equipment validation and qualification. Main Text/s and any supplementary readings: - Agalloco J, Carleton FJ, editors. Validation of pharmaceutical processes. New York: Informa Healthcare USA Inc; 2008. - Nash RA, Wachter AH, editors. Pharmaceutical Process Validation. New York: Marcel Dekker Inc; 1993. - Sharp J. Quality in the Manufacture of Medicines and other Healthcare Products. London: Pharmaceutical Press; 2000. - Tobin JJ, Walsh G. Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices. Germany: Wiley-Blackwell, 2008. |
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| RULES/CONDITIONS | Before TAKING THIS UNIT YOU MUST TAKE PHR2604 | ||||||||
| STUDY-UNIT TYPE | Lecture | ||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Anthony Serracino Inglott Marie Claire Zammit |
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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 2025/6. It may be subject to change in subsequent years. |
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