Unit Code: CHM615

Unit Name: Good Laboratory and Manufacturing Practices

Description: This unit focuses on the importance of GLP and GMP as well as some common international standards. Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. (Current) Good Manufacturing Practice (cGMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. Published GLP and cGMP regulations have a significant impact on the daily operation of an analytical laboratory. ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. Thus it is imperative for laboratory technicians to have sufficient working knowleghe of GLP/GMP as well as ISO International Standards.

Learning Target Outcomes: On successful completion of this course, students will be able to understand the following a. Explore the details and applications of GMP/GLP standards-compliant environment. b. Illustrate the purpose and reasoning of GMP/GLP Regulations and their practical application through key quality systems. c. Describe the QA-GMP-QC relationship. d. Enable participants to appreciate the individual GMP responsibilities, and quality management responsibilities, and know the consequences. of failure to comply with the GMP/GLP Regulations. e. Illustrate the importance of good documentation practices and record keeping.

Prerequisite: Pass in CHM501 or CHM503

Prerequisite Sentence: Minimum Entry Requirement of the programme

Credit Point: 15

Offered In: Semester 1