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ICH Q5C was published as an Annex to the Tripartite ICH Guideline for Stability of new Drug substance and Products. %PDF-1.4
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If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. Q5C Current Step 4 version dated 30 November 1995 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. 0000001409 00000 n
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While ICH documents have not specifically addressed considerations for demonstrating comparability between pre-change and post-change product, several ICH documents have provided guidance for technical information and data to be submitted in marketing applications that can also be useful for assessing manufacturing process changes (see Section 4.0 References).
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ICH Q5C intends to give guidanceto applicants regarding the type of stability studiesto be provided in support of marketing authorisation applicationsfor biological medicinal products. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. 0000001388 00000 n
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This document covers the generation and submission of stability data for well-characterised proteins and polypeptides, their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. 0000106873 00000 n
For the basic terms used in this annex the reader is referred to the "Glossary" in the ICH Harmonised Tripartite Guideline ‘Stability Testing of New Drug Substances and Products’ (27 October 1993). 0000001578 00000 n
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EMA is in the process of making appropriate changes to this website. 0000072740 00000 n
This document builds upon … 0000079101 00000 n
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This document covers the generation and submission of stability data for well-characterised proteins and polypeptides, their derivatives and products of which they are components, and which are isolated from tissues, body fluids, cell cultures, or produced using rDNA technology. 0000003596 00000 n
The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. 0000107087 00000 n
It may also apply to other types of products, such as conventional vaccines, after consultation with the appropriate regulatory authorities. 0000003329 00000 n
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