ICH-Q11 appears on the horizon: development and manufacture of drug substances

The concept paper (2) summarizes the goals of the guideline, as follows: * Harmonize and encourage the submission of relevant documents regarding the manufacturing process information and its justification. * Outline the science-based concepts relevant to the design of a robust manufacturing process that reliably delivers a quality drug substance. * Provide examples as appropriate of acceptable approaches for demonstrating process and product understanding. * Facilitate the regulatory evaluation process for authorities. * Recommend approaches for demonstrating process and product understanding. * Address the complexity of different manufacturing processes and products. * Accommodate variable approaches to development and corresponding information to be provided as described in Q8andQ8R. * Address enhanced approaches to manufacturing that can also create a basis for alternative approaches to control the quality of a product and for the application of innovative technologies for the manufacture of APIs (e.g. continuous manufacture). * Address systematic approaches to drug substance development, application of quality risk management, and concepts such as design space, control strategies (including real-time release) over the lifecycle of the product.