The ICH Q13 Guideline on "Continuous Manufacturing of Drug Substances and Drug Products (Step 4)" was eventually adopted during the International Council for Harmonisation (ICH)General Assembly in Mid-November.
The 46-pages guidelines include the following:
• Builds on current ICH Quality Guidelines
• Provides clarity on continuous manufacturing (CM) concepts
• Explains scientific approaches and suggests regulatory considerations specific to CM of drug products and drug substances
• Focuses on a CM system's integrated aspects in which two or more unit operations are directly connected
• Includes regulatory and scientific deliberations for CM's development, implementation, operation, and lifecycle management.
The preliminary Part I of the guideline considers the CM concepts, the scientific approach, and regulatory considerations like manufacturing processes, process validation, batch sizes, control strategies, product stability, and the pharmaceutical quality system.
Part II includes five annexes that offer straightforward explanations and practical examples.
Annexe 1,2,3,4 respectively: Considerations for CM of drug substances, drug products, drug substances (therapeutic proteins) and integrated drug substances and drug products CM
Annexe 5: Perspectives of managing disturbances.
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