100% Laboratory Portfolio (learning outcomes 1-3). Information on what is needed will be provided through lectures and blackboard. This will also include a summary produced by the student summarising all of the laboratory sessions undertaken. The portfolio will require background reading to answer questions and problems. Also, students will be required to provide a laboratory record including notes and raw analysis results showing evidence of good clinical laboratory practice.

Formative Assessment:

Directed discussion within blackboard and discussions in the practical sessions will be utilised to provide formative feedback. Students will also be able to submit laboratory report(s) for formative feedback for the report writing.

In this module students will build on knowledge gained in the module Characterisation and Analysis of Drugs. Students will study scientific principles which underpin quality assurance such as quality control, good manufacturing practice, monitoring and compliance, and how the range of analysis techniques previously studied may be used for this purpose.
As such students will be address Quality Assurance and Quality Control in a pharmaceutical context the will evaluate the analytical techniques in the roles of determining identity and purity. The module will also identify the need for good manufacturing practice and the importance of good clinical laboratory practice.

Lecture/tutorial sessions (12 x 2h) will be used to provide the theory and allow students to apply data analysis to case examples to provide a real world context.

Laboratory exercises (6 X 3h) will be run in small groups (2-3 students, working as a team).

The remaining hours will involve directed reading and activities, accessing and studying information provided through Blackboard, preparation for practical sessions and production of laboratory reports.

Appropriately equipped laboratories.

Pre-requisite module, Characterisation and Analysis of Drugs.

Reese, J. et al (2015) Introduction to Pharmaceutical Calculations. 2nd edition Pharmaceutical Press.

Rowe, P (2015) Essential Statistics for the Pharmaceutical Sciences. 2nd edition. Wiley-Blackwell.

Wenclawiak, B. and Michael Koch, M. (2010) Quality Assurance in analytical chemistry.

W.H.O. (2014) Quality Assurance of Pharmaceuticals 2014. World Health Organization

1. Demonstrate knowledge and critical understanding of a range of current analytical techniques, equipment and their application.
KNOWLEDGE AND UNDERSTANDING, LEARNING

2. Apply the Principles of quality assurance to the interpretation of data generated by a range of analytical techniques.
APPLICATION, PROBLEM SOLVING

3. Communicate knowledge in the form of written reports; Appropriately interpret analysis results, showing understanding of their significance and the underpinning theory.
APPLICATION, COMMUNICATION, PROBLEM SOLVING