96059 International GMPs and Quality Assurance
6cp; standard mode: 3hpw (on campus workshop); distance mode: offered online, requiring no on-campus attendanceThere are course requisites for this subject. See access conditions.
Description
This subject provides an introduction to good manufacturing practice (GMP), with a focus on international aspects and quality assurance (QA). It covers the fundamental requirements for GMPs and the obligations of manufacturers and managers to implement or maintain GMP compliance and QA in the manufacture of human or veterinary therapeutic products. It reviews critical QA systems including design and change control, deviation and error control, and corrective and preventative action (CAPA). Documentation systems and practices related to GMP are also addressed. GMP requirements for manuals, policies, standard operating procedures (SOPs), work instructions and records are explored, leading to discussion on a model hierarchical documentation system based on ISO 9000, a body of quality management systems standards. This subject investigates change control programs and overviews the cGMP requirements for managing complaints and recalls.
Typical availability
Autumn session, City campus
Detailed subject description.