A3P Product Lifecycle
Control strategy / CPV / AQbD / Statistical intervals / ICHQ12
Introduction
The A3P Analytical, CPV, ICHQ12, Statistics and QbD GIC are working together on these days dedicated to the product life cycle. These 5 themes are all working towards the same goal: Product life cycle Management.
QbD is a real product and process design tool, based on science and risk analysis, which will enable us to build a process control strategy culminating in Process Validation.
The CPV, a monitoring process, will confirm the validated state of the process over time.
ICH Q12 provides a framework for the management of post-approval changes affecting the quality of pharmaceutical products. Its main aim is to facilitate the management of these changes, make the process more predictable and efficient, and minimize regulatory variations.
Statistical and analytical tools are used throughout the product life cycle.
This coherence between these 5 themes has led A3P to bring them together during the “Product Lifecycle - 2025” days. Members of these GIC will be presenting conferences based on their work, control strategy, CPV implementation and the platform approach. The application of statistical tools, such as experimental design, and predictive tools for development will also be presented.
An exhibition of supplier companies will enable you to discover the market innovations available to manufacturers, and the implementation of these approaches deployed during the product life cycle at partner workshops. 2 visits to analysis laboratories will also be offered.
QbD is a real product and process design tool, based on science and risk analysis, which will enable us to build a process control strategy culminating in Process Validation.
The CPV, a monitoring process, will confirm the validated state of the process over time.
ICH Q12 provides a framework for the management of post-approval changes affecting the quality of pharmaceutical products. Its main aim is to facilitate the management of these changes, make the process more predictable and efficient, and minimize regulatory variations.
Statistical and analytical tools are used throughout the product life cycle.
This coherence between these 5 themes has led A3P to bring them together during the “Product Lifecycle - 2025” days. Members of these GIC will be presenting conferences based on their work, control strategy, CPV implementation and the platform approach. The application of statistical tools, such as experimental design, and predictive tools for development will also be presented.
An exhibition of supplier companies will enable you to discover the market innovations available to manufacturers, and the implementation of these approaches deployed during the product life cycle at partner workshops. 2 visits to analysis laboratories will also be offered.
