Guidance on Q13 Continuous Manufacturing of Drug Substances and Drug Products
The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.
A new industry guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, issued in March 2023 by FDA, explains the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance and to provide clarification on CM concepts while further describing scientific approaches and regulatory considerations specific to CM of drug substances and drug products.
Further, the guidance applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. It can be applicable to CM for new products, such as new drugs, generic drugs, and biosimilars, and for the conversion of batch manufacturing to CM for existing products.
Source: FDA
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
