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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.

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...

Jul 27, 2021 · The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process on 27 July 2021 and now enters the public consultation period. This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous ...

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, …

ICH Q13 Guideline 1 1 PART I: CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG 2 PRODUCTS 3 4 1. INTRODUCTION 5 1.1. Objective 6 This guideline describes scientific and regulatory considerations for the development, 7 implementation, operation, and lifecycle management of continuous manufacturing (CM).

Continuous feeding of input materials into, the transformation of in-process materials within, and the concomitant removal of output materials from a manufacturing process. • Potential to improve...

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.

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 …

Jan 25, 2023 · Now ICH has approved the final version. The ICH Q13 guideline describes scientific and regulatory considerations for the development, implementation, operation and life cycle management of continuous manufacturing.

This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing of drug substances and drug products.

Jul 27, 2021 · Further to the ICH Q13 draft document reaching Step 2b of the ICH Process on 27 July 2021, the Step 2 Informational Presentation developed by the ICH Q13 EWG has been finalised. The Step 2 Informational Presentation and additional information can be found on the ICH Q13 Guideline page .

Mar 20, 2023 · Continuous Manufacturing of Drug Substances and Drug Products | ICH Q13 Guideline March 20, 2023 This guideline describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM) of drug substances and drug products.

ICH is a consensus-driven process that involves technical experts from regulatory authorities and industry parties in detailed technical and science-based harmonization work that results in the development of ICH guidelines.

ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products is a Quality guideline that provides scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM processes.

Building on existing ICH Quality Guidelines, provides clarification on CM concepts, describes scientific approaches, and presents regulatory considerations specific to CM of drug substances and drug products. Applies to CM of drug substances and drug products for chemical entities and therapeutic proteins.

Sep 8, 2021 · The new guideline ICH Q13 Continuous Manufacturing of Drug Substances and Products covers active ingredient and drug production manufacturing as well as the production of therapeutic proteins and combined or integrated active ingredient and drug production. It comprises the development, implementation and operation of continuous manufacturing ...