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New ICH guideline to regulate Continuous manufacturing of drug substances and drug products

What is continuous manufacturing?

The term "continuous production" refers to a manufacturing method in which the materials being processed are constantly moving. Continuous production is a flow production process:  different parts flow from one machine to the next in continuous processing to create a finished product.

What are the benefits of continuous production?

Shorter production periods — it's not uncommon to reduce production times from weeks to days. Eliminates the possibility of human error. Improves the standard of living. Continuous manufacturing processes generally incorporate automated monitoring techniques and predictive maintenance, making monitoring more efficient.

ICH Guideline Q13

ICH guideline help everyday professionals to learn and shape the quality system of their company. It is a reference which is on the top of next challenge in the field .

In June 2018, the Assembly approved the initiation of a guideline regarding continuous Manufacturing. The purpose of this new guideline is to:

Capture critical technical and regulatory concerns that encourage standardisation, including some CGMP components particular to Continuous Manufacturing (CM),

Allow drug producers to create, implement, or integrate CM for manufacturing in a flexible manner .

The content includes indication on:


Different Modes of CM

Batch definition


Control Strategy Changes in Production Output

Continuous Process Verification


Process Description

Control Strategy

Batch Description

Process Models

Drug Substance and Drug Product Stability

Conversion of a Batch Process to CM

Process Validation

Pharmaceutical Quality System

Lifecycle Management

Submission of CM-Specific Information in the CTD

The Guideline is also full of examples to support compliance with the procedure for example section below there is an EXAMPLE of SYSTEM OVERVIEW:

Key dates

Release for public consultation 29 July 2021

Deadline for comments 20 December 2021

Full content is available here ich-guideline-q13-continuous-manufacturing-drug-substances-drug-products-step-2b_en.pdf (

Disclaimer: the copyright of any information provided belongs to ICH and the content of this article shouldn't be used as a reference

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