Drugs

Q13 Drug Continuous Manufacturing Guidance

FDA has published a guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, describing the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). The document says it builds on existing International Council for Harmonization quality guidances to provide clarification on CM concepts and describe scientific approaches and regulatory considerations specific to CM of drug substances and products.

The guidance applies to CM of drug substances and products for chemical entities and therapeutic proteins, FDA says. It applies to CM for new products and the conversion of batch manufacturing to CM for existing products.

“Fundamental aspects of CM that are generally not specific to technology, dosage form, or molecule type are described within the main body of this guidance,” the document says. “Annexes are provided to augment the main body of the guidance by providing illustrative examples and considerations specific to certain modalities. The examples and approaches described in these annexes are illustrative, and alternative approaches can be used.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome