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Introduction

This document outlines the course CN4233R Good Manufacturing Practices in Pharmaceutical Industry. The module objectives are to develop an understanding of regulatory requirements for Good Manufacturing Practices and introduce analytical techniques used in quality control. The course is split into two parts, with the first focusing on regulatory aspects taught by Dr. Kyle and Ms. Ai See, and the second on analytical techniques taught by Dr. Gautam. Students will learn about quality assurance systems, GMP regulations, and analytical methods for assessing drug quality. Assessment includes two tests and two group projects. Required texts cover GMP guidelines and quality control analysis.

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Nigel Kow
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© © All Rights Reserved
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108 views

Introduction

This document outlines the course CN4233R Good Manufacturing Practices in Pharmaceutical Industry. The module objectives are to develop an understanding of regulatory requirements for Good Manufacturing Practices and introduce analytical techniques used in quality control. The course is split into two parts, with the first focusing on regulatory aspects taught by Dr. Kyle and Ms. Ai See, and the second on analytical techniques taught by Dr. Gautam. Students will learn about quality assurance systems, GMP regulations, and analytical methods for assessing drug quality. Assessment includes two tests and two group projects. Required texts cover GMP guidelines and quality control analysis.

Uploaded by

Nigel Kow
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Introduction

Ms. Ai See
Email: [email protected]

Dr. Kyle K.L. Phua


E4-05-12
Email: [email protected]
Tel: 6601 3877

Dr. Satyen Gautam


E1-02-07
Email: [email protected]
Tel: 6601 3065

CN4233R
Good Manufacturing Practices in Pharmaceutical Industry

Module Objectives
Develop within students a good understanding of the
basics of regulatory requirements with an emphasis on
applying Good Manufacturing Practices (GMPs)
GMP is a system for ensuring that product are
consistently produced and controlled according to quality
standards World Health Organization

Introduce various analytical techniques employed in the


pharmaceutical industry to assess the quality of biologics

Course Outline
Part 1: Regulatory Aspects of Pharmaceutical Manufacture
(Taught by Dr Kyle and Ms Ai See)
Pharmaceutical Quality Assurance System
International Regulations Governing GMP
Compliance Issues for Pharmaceuticals

Part 2: Analytical Techniques


(Taught by Dr Gautam)

for

Quality

Control

Overview of Biomanufacturing
Introduction to Quality Control
Analytical Techniques for QC of Protein-based Biologics
Industrial Talk (TBA)
3

Module Learning Outcomes


On successful completion of this module, students will be able to:
Explain the concept of quality assurance system and its importance in
pharmaceutical manufacture
Apply the concepts and principles of good manufacturing practice and
associated elements (standard operating procedures, documentation,
validation, organization and personnel, premises, equipment,
production) to solve real-world problems
Explain the different quality aspects of pharmaceuticals
Describe the working principle of analytical techniques used to assess
drugs quality
Apply the knowledge of analytical methods to solve quality controlrelated problems
Work in a team in such a way that all members contribute individually
as well as collectively with effective communication and coordination

Assessment
CA Components: 100%
Test 1 (Conducted by Ms Ai See and Dr Kyle): 15%
Test 2 (Conducted by Dr Gautam): 15%
Group Project 1 (Conducted by Ms Ai See): 35%
Group Project 2 (Conducted by Dr Gautam): 35%

Texts
Kanarek and P. Seymour, Good Manufacturing Practices: Guide to
Compliance, 5th Ed., Barnett Educational Services, 2012.
EudraLex - Good Manufacturing Practice (GMP) Guidelines, Volume 4.

(http://ec.europa.eu/health/ documents/eudralex/vol-4/)
Part 211 Current Good Manufacturing Practice for Finished
Pharmaceuticals.
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm
?CFRPart=211)
ICH Quality Guidelines.
(http://www.ich.org/products/guidelines/quality/article/qualityguidelines.html)
S. Ahuja and S. Scypinski, Handbook of Modern Pharmaceutical
Analysis, Volume 10, Academic Press, 2011
6

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