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The guideline continues to provide a general framework for the principles of analytical procedure validation applicable to products mostly in the scope of Q6A and Q6B. These guidelines (Q2(R2) and Q14) are intended to complement ICH Q8 to Q12 Guidelines, as well as ICH Q13 for Continuous Manufacturing.

Oct 7, 2023 · This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).

Building on existing ICH Quality guidelines, this guideline provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.

Mar 1, 2023 · Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory...

Feb 24, 2023 · Involves the continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process. Focuses...

Nov 19, 2024 · The ICH Secretariat is pleased to announce the publication of ICH Q13 IWG " Continuous Manufacturing of Drug Substances and Drug Products" Modules 1-12 video training material. Modules 1-12 are available for download on the ICH Q13 IWG webpage and in the ICH Training Library.

Although CM is relatively new for pharmaceutical applications, there is sufficient information available to develop an ICH guideline. Fundamental scientific approaches and CM knowledge that is transferrable from other industries (for example, …

The creation of a new ICH guidance document, Q13, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and …

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.