Good Manufacturing Practice, Standards and Quality Systems

This module will introduce the students to key quality control, quality assurance and quality management processes in current good manufacturing practice (cGMP) regulated drug manufacturing industries.  This module will outline the role of the major regulatory bodies from drug discovery to market and identify the key quality standards which govern GMP in the pharmaceutical, biopharmaceutical and medical device industries. Upon the completion of this module students should be able to explain, using illustrative examples, how GMP is essential from initial clinical trials to commercial product launch and subsequent pharmacovigilance market surveillance. Students should be able to recognise non-compliance in a GMP controlled manufacturing environment and outline the importance of instrument validation and calibration in quality control.

1. Differentiate between the major drug manufacturing processes in pharmaceutical, biopharmaceutical and medical device industries.

2. Describe the role and function of quality control (QC), quality assurance (QA), current good manufacturing practice (cGMP) and good laboratory practice (GLP) within the pharmaceutical, biopharmaceutical and medical device Industries.

3. Identify the major regulatory bodies and international quality standards which regulate/audit drug production and manufacturing, from drug discovery to pharmacovigilance market surveillance.

4. Review EU Eudralex Volume 4 GMP guidelines and apply this knowledge to audit practices for GMP compliance in industry.

5. Explain the significance of instrument validation and calibration in relation to the maintenance of QC and GLP in industry.