Translation 4: Phase Appropriate GMPs​

The transition from drug discovery through to commercialisation is a long and complex journey that can take many years and exponentially increasing in compliance and regulation. It is a critical success factor to ensure that there is a practical approach to the application of phase appropriate GMPs across the development program. Overreach of GMPs and compliance programs can lead to delays in innovation and rapid development. Under control can cause delays in product registration a significant GMP non-compliance which can create barriers to market entry. This module aims to bring clarity in relation to what GMPs to apply at what phase of development.