Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and drug products have achieved this in many cases, biologics are behind the global implementation of CM because of their more complex manufacturing processes. 

However, the regulatory agency members of the International Committee for Harmonization (ICH) now have enough experience in the registration, review, and approval of CM processes to issue a new guideline for industry. 

The ICH’s Continuous manufacturing of drug substances and drug products Q13 draft version describes the scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM. It has asked for industry feedback. 

Overall, the BioPhorum team thinks the draft reads well and the concepts and ideas are aligned with its thinking on CM for biologic drug substances and drug products. 

The team’s in-depth feedback includes more than 40 line-by-line, detailed comments on the ICH document. These include the need for improved definitions of terms, their alignment with those already developed by industry (e.g., in the ASTM standards for continuous processing) and the need to consider ‘process fatigue’. 

Other comments include clarifying the wording on batch sizes, clearer guidance on regulatory expectations on what constitutes a pilot batch for CM, and the need to align statements with ‘quality by design’ principles. 

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Industry feedback on ICH harmonised guideline February 2022.pdf
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  continuous downstream processing     continuous manufacturing     regulatory     Regulatory Governance  
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  • Create Date 21st February 2022
  • DOI https://doi.org/10.46220/2022REG004
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