96067 Supply Chain Management6cp; Standard mode: 3hpw (on campus workshop); distance mode: offered fully online, requiring no on-campus attendance
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
This subject provides an overview of the complex supply chains involved in the manufacture of pharmaceuticals. It describes the challenges faced by the industry and regulatory bodies, and the current initiatives to minimise the risks and improve regulatory oversight.
Students are provided with detailed information relating to the control of materials and components by the original manufacturer and throughout the supply chain; as well as to the chain of systems ensuring the integrity and accuracy of information from originator to routine production and on to the customer. The roles and responsibilities of pharmaceutical manufacturers and their suppliers are explored, and the importance of collaboration in the supply chain to identify and manage risks, ensuring the safety and reliable supply of effective medicines. A model for supplier qualification is presented, and students are supported in the design and development of a robust and comprehensive quality system that addresses the requirements for traceability and interoperability throughout the supply chain.
Autumn session, City campus
Detailed subject description.