In July 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced that the ICH Q13 draft Guideline, which provides for the Continuous Manufacturing of Drug Substances and Drug Products, has reached Step 2 of the process and is now opening to the Public Consultation.

At this stage, the Regulatory Agencies belonging to the Council present the draft for the regulated sector, with the objective of collecting contributions and comments from the population. After the consultation period, the Authority compiles the information and sends it directly to the ICH.

This guideline outlines the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of Continuous Manufacturing (CM). The document is a quality guideline and provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to the CM of drug substances and drug products.

The guideline applies to drug substances and drug products for chemical entities and therapeutic proteins. It is also applicable to new products (eg new products, generic drugs, biosimilars) and also describes guidelines for converting the traditional manufacturing process (in batch form) to CM in products that are already present on the market. The principles described in this guideline may also apply to other biological/biotechnological entities.

The European Medicines Agency (EMA) and ANVISA have already published, on its website, the draft guideline for Public Consultation. The comments must be submitted using a specific form in accordance with the instructions of each agency.

Access the Q13 page at ICH website: https://bit.ly/3xlMQAZ.

Access the draft of ICH Q13 guideline, published by the EMA, directly on the Authority’s website: https://bit.ly/3ly3NWB.

Access the Public Notice published by ANVISA to collect contributions to ICH Guide Q13: https://bit.ly/3jLympc

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