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

Location:
Footscray Park
Werribee
Study level:
Undergraduate
Credit points:
12
Unit code:
NPU3101

Prerequisites

NPU2102 - Analytical Methods 2

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Learning Outcomes

On successful completion of this unit, students will be able to:
  1. Critically review the industry standards in pharmaceutical laboratory management and practice both locally and globally;  
  2. Develop risk assessments on laboratory practice including the identification of physical/chemical hazards and proposing methods of minimising risk;  
  3. Review industry quality systems both locally and globally and initiate good laboratory practice (GLP) and good manufacturing practice (GMP) in own context;  
  4. Devise an analytical protocol incorporating method selection, method verification, method validation and measurement uncertainty;  
  5. Apply standard methodology to the analysis of various pharmaceutical samples including method selection, sample preparation, instrumental operation and data analysis so as to develop current industry specific instrumental competency; and  
  6. Review and present data to peers and demonstrators with responsibility and accountability.  

Assessment

Assessment type Description Grade
Assignment Written Risk Assessment (500 words) 10%
Laboratory Work Portfolio of Laboratory work with summary addressing criteria (1500 words) 40%
Project Written Assignment (3000 words) 50%
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 (4,5) of this unit, a student MUST pass the laboratory component in order to pass the unit.

Required reading

Fundamentals of Analytical Chemistry 9th ed.
Skoog, D. A., West. D. M., Holler, F. J. and Crouch, S. R., (2014)
Brooks/Cole, Cengage learning

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