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:
- INTRODUCTIONS
Different Modes of CM
Batch definition
- SCINTIFIC APPROACHES
Control Strategy Changes in Production Output
Continuous Process Verification
- REGULATORY CONSIDERATIONS
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 (europa.eu)
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