Pharmaceutical Regulatory Processes has as its foundation the fundamental chemical principles introduced in Chemistry 1A and 1B and underlying basics of instrumental chemical analysis and synthetic organic chemistry studied in Analytical Methods 1 and Organic Synthesis, respectively. The Unit provides students with training in pharmaceutical laboratory management and presents an overview of current pharmaceutical laboratory practice. Topics covered include occupational health and safety; quality systems including GLP, GMP and accreditation of laboratories; analytical methods and reliability of scientific data; familiarisation with international standards (ICH and FDA) and official methods of analysis (British and US Pharmacopeia).

Assessment includes report writing according to industry standards. For students interested in teaching chemistry this unit along with Drug Testing and Analysis extends the minimum requirements (see four units mentioned above) and gives a working insight into more advanced chemistry and industry specific practice.   

Unit details

Study level:
Undergraduate
Credit points:
12
Unit code:
NPU3101

Prerequisites

NPU2102 - Analytical Methods 2

Learning Outcomes

On successful completion of this unit, students will be able to:
  1. Develop risk assessments on laboratory practice including the identification of physical/chemical hazards and proposing methods of minimising risk;  
  2. Devise an analytical protocol for a targeted pharmaceutical product incorporating method development, validation and review;  
  3. Apply standard methodology to the analysis of a selected pharmaceutical sample including method selection, sample preparation, instrumental operation and appropriate statistical data analysis; and  
  4. Review and present results in a professional format.  

Assessment

Assessment type Description Grade
Assignment Written Risk Assessment (500 words) 10%
Laboratory Work Laboratory Workbook (hurdle task) 20%
Report Laboratory Report - portfolio of laboratory work describing the method development and validation. 40%
Project Written Assignment (2500 words) 30%
Laboratory work and the development of practical skills are a critical component of this unit. Students must therefore attend all of the laboratory sessions and as the laboratory sessions are a critical part of the learning outcomes of this unit, a student MUST pass the laboratory component in order to pass the unit.

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