PHRM07012 2019 ACTIVE INGREDIENT SYNTHESIS
This module involves the synthesis of a range of Active Pharmaceutical Ingredients and associated regulatory aspects of the process.
On completion of this module the learner will/should be able to;
Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.
Analyse some standard synthetic methods and use these to generate manufacturing documentation in line with cGMP.
Determine quantities of starting materials as well as relevant glassware and equipment required for each synthesis
Generate and follow Standard Operating Procedures (SOP's) in the use of some standard laboratory equipment .
Record and report on the synthetic method, including any deviations or variations to the process.
While working as a member of a group, evaluate the risks associated with each synthetic method and understand how to mitigate against these risks
Teaching and Learning Strategies
This module will be delivered full-time. It will consist of a series of laboratory practicals culminating in the synthesis of selected API's.
Moodle will be used as a repository of educational resources.
Module Assessment Strategies
Students will be assessed based on laboratory performance and results. Further assessment methods include a series of pre- and post laboratory assessments as well as Moodle based multiple choice and short answer questions.
Students may repeat Continuous Assessment as required
This module encompasses API synthesis
Practical sessions will include,
Generation of Standard Operating Procedures (SOP's)
Active Pharmaceutical Ingredient (API) synthesis
Emphasis throughout is on awareness of GMP / GLP requirements in a pharmaceutical environment.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Practical Evaluation Performance in laboratory sessions||Formative||Practical Evaluation||- %||OnGoing||1,2,3,4,5,6|
|2||Group Project Maufacturing processing and reporting||Continuous Assessment||Group Project||100 %||OnGoing||1,2,3,4,5,6|
Full Time Mode Workload
|Laboratory Practical||Science Laboratory||Laboratory Practical||3||Weekly||3.00|
|Independent Learning||Not Specified||Self Study||3||Weekly||3.00|