ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.

It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.

Keywords: Continuous Manufacturing (CM), Pharmaceutical development, quality, quality by design, control strategy, process models, GMP, lifecycle management

Current version

ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5

AdoptedLegal effective date: 10/07/2023Reference Number: EMA/CHMP/ICH/427817/2021

Document history

ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5

AdoptedLegal effective date: 10/07/2023Reference Number: EMA/CHMP/ICH/427817/2021

Overview of comments received on draft ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

Reference Number: EMA/771847/2021

Draft ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

Consultation dates: 29/07/2021 to 20/12/2021Draft: consultation closedReference Number: EMA/CHMP/ICH/427817/2021Summary:

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products.

This guideline applies to CM of drug substances and drug products for chemical entities and therapeutic proteins. The principles described in this guideline may also apply to other biological/biotechnological entities.

It is applicable to CM for new products (e.g., new drugs, generic drugs, biosimilars) and the conversion of batch manufacturing to CM for existing products.