Course Summary

The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards.

This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.

Who will benefit from this module?

This module provides essential learning for all personnel of analytical laboratories, especially those working on quality control sampling and testing in a medicinal products manufacturing environment.

Learning Objectives

• Access guidelines and regulations relevant to GQCLP
• Outline the role and elements of a laboratory quality system
• Specify some basic laboratory safety practices
• Identify key types of laboratory document and summarise their contents and relationships
• Outline the management of reference standard substances and reagents
• Specify good practices for data recording and record keeping
• Describe how to handle out-of-specification conditions
• Specify some good housekeeping rules for the laboratory, and outline the role of audits and inspections

Module Outline

Key topics covered in this module include:

• Laboratory quality system
• Basic laboratory safety practices
• Laboratory documentation
• Reference standards and reagents
• Record keeping and data recording
• Managing out-of-specification events
• Housekeeping, inspections and audits