One way that USP assists manufacturers who are considering adoption of pharmaceutical continuous manufacturing (PCM) is with technical guides* that can help them ensure quality. While regulatory guidance on PCM is available from ICH and FDA, the technical guides provide more detailed, practical illustrations of key concepts that can help ensure quality.
We have the following technical guides on PCM:
- Control strategies for continuous manufacturing of solid oral dose drugs. For a high-level overview of the guide, see the related Quality Matters blog.
- Process Modelling for advanced manufacturing technologies (AMT). The guide presents a detailed conceptual and practical framework of process modeling in PCM with a special focus on Residence Time Distribution (RTD) modeling techniques.
- In-vitro Dissolution Modeling for Oral Solid Drug Product Continuous Manufacturing. This guide focuses on presenting the state-or-the-art in surrogate dissolution models that can help in developing real-time release strategies.
- Control strategy for continuous manufacturing of drug substances. This guide focuses on elements of control strategies for continuous manufacturing of chemically synthesized small molecule drug substances, also known as active pharmaceutical ingredients (API). It introduces the fundamental concepts of continuous manufacturing and control strategy, describes the typical equipment and process design of API manufacturing lines, and uses an example process to demonstrate the key aspects in the development and reporting of control strategies.
- New guide available: This USP Technical Guide provides an overview of powder characterization in pharmaceutical continuous manufacturing, with a focus on powder-to-tablet processes for solid oral dosage forms. It highlights the importance of robust control strategies aligned with ICH Q13 and Quality by Design principles, and outlines USP standards and testing methodologies that support powder characterization and resilient CM systems.
To download the guides, please complete and submit the form.
Please note that the technical guides are a practical resource for industry stakeholders developing PCM processes but do not constitute official USP standards.
To provide feedback on the technical guides or input for future guides, email PCM@usp.org
*Related legal disclosures and terms of use are located within the guide.
