96134 Validation Principles and Practices6cp; standard mode: 3hpw (on campus workshop); distance mode: offered online, requiring no on-campus attendance
There are course requisites for this subject. See access conditions.
Knowledge, understanding and application of the regulations, processes and strategies for validation in manufacturing operations is critical for implementing good manufacturing practice (GMP). Validation principles for current good manufacturing practices (cGMPs) are introduced, and students examine the validation requirements of various pharmaceutical regulatory bodies and international organisations, including the Therapeutic Goods Administration (TGA) of Australia, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the International Conference on Harmonisation (ICH). Students extend the principles of validation to practical outcomes encompassing practical workshops in preparing validation protocols from planning, through equipment qualification to process validation, evaluation of validation results and how to conduct cleaning validation.
Detailed subject description.