University of Technology, Sydney

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96058 Validation Principles

6cp; 1hpw (lecture), 2hpw (workshop), on campus
There are course requisites for this subject. See access conditions.

Description

Knowledge and understanding of the regulations, validation processes and strategies for manufacturing operations is critical for implementing good manufacturing practice (GMP). This subject addresses the fundamental processes required for establishing, adherence and reviewing of pharmaceutical processes in industry. 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). The scope and purpose of validation is explored, and students build knowledge for preparing and interpreting validation master plans. The subject guides the understanding and development of installation qualification (IQ) and operational qualification (OQ) protocols for critical equipment and services. The latter half of the subject assesses performance qualification (PQ) and process validation, focusing on the critical steps in preparing validation protocols through to techniques used to retrospectively review and re-validate existing production processes and products.

Typical availability

Autumn session, City campus


Detailed subject description.

Fee information

Information to assist with determining the applicable fee type can be found at Understanding fees.

Access conditions

Note: The requisite information presented in this subject description covers only academic requisites. Full details of all enforced rules, covering both academic and admission requisites, are available at access conditions and My Student Admin.