1.Introduction
1.1 Objectives of the Guideline
The following guideline outlines the stability data expectations for drug substances and drug products.This guideline is applicable to marketed drug products, including those associated with registration and lifecycle/post-approval changes and, when applicable, master files. These applications are hereafter 6 collectively referred to in the guideline as regulatory submissions. ICH Q1 is a consolidated revision that supersedes ICH Q1A-F and Q5C guidelines and provides additional guidance on principles relating 8 to stability.
1.2 Scope of the Guideline
This guideline applies to synthetic and biological drug substances and drug products, including the 11 following:
• Chemically synthesised drug substances including oligonucleotides, polysaccharides and polypeptides (collectively referred to as ‘synthetic chemical entities’ or ‘synthetics’ in this guideline), semi-synthetic drug substances and fermentation-derived drug substances.
• Therapeutic proteins/polypeptides, polysaccharides and proteoglycans produced using recombinant DNA (rDNA) technology or isolated from human, animal or plant tissues, other natural sources, including body fluids (such as plasma-derived products), or cell cultures.
• Conjugated products that are made up of proteins/polypeptides linked to another moiety (e.g., antibody-drug conjugate).
• Vaccines, allergenic products, and adjuvants.
• Autologous and allogenic cell-based substances, including those which may be genetically modified ex-vivo (refer to Annex 3 – Stability of Advanced Therapy Medicinal Products (ATMPs)).
• Gene therapy products that mediate their effect by the expression (transcription or translation) of transferred genetic materials and genome editing products used to modify cells (refer to Annex 3 – Stability of Advanced Therapy Medicinal Products (ATMPs)).
• The drug constituent part of a combination of a drug product with a medical device (both 28 integral or co-packaged).
• Co-packaged solvents/diluents.
• Natural health products that are regulated as drug products
Source: ICH, Pls check the follow
ICH_Q1EWG_Step2_Draft_Guideline_2025_0411.pdf
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