Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
The ICH Harmonised Guideline was finalized under Step 4 in March 1997.
This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin and outlines data that should be submitted in the marketing application/registration package. The purpose of this Guideline is to provide a general framework for virus testing, experiments for the assessment of viral clearance and a recommended approach for the design of viral tests and viral clearance studies.
Please note that a typographic error has been corrected on 23 September 1999 on Table A-1: the Genome of the Reovirus 3 is RNA (and not DNA as previously printed). The correction was integrated in the Guideline that was then renamed Q5A(R1).
The ICH Harmonised Guideline was finalized under Step 4 in November 1995. This document is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.
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Date of Step 4: 23 September 1999
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Q5A(R2)EWG Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
This topic was endorsed by the ICH Assembly in June 2019.
The Q5A(R2) EWG is working on the revision of the of the Q5A(R1) Guideline “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin” with a view to reflecting new biotechnology product types, advances in manufacturing technology, analytical methods for virus testing, and scientific knowledge that have occurred since publication of the original document in 1999.
Endorsed Documents (Click the links below for complete guidelines)
Q5B Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
The ICH Harmonised Guideline was finalized under Step 4 in November 1995. This document is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.
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Date of Step 4: 30 November 1995
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
The ICH Harmonised Guideline was finalized under Step 4 in November 1995. This document augments the stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.
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Date of Step 4: 30 November 1995
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Q5D Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
The ICH Harmonised Guideline was finalized under Step 4 in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbial cells used to prepare biotechnological/biological products, and for the preparation and characterization of cell banks to be used for production.
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Date of Step 4: 16 July 1997
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
The ICH Harmonised Guideline was finalized under Step 4 in November 2004.
The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product.
Therefore, this Guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product.
The document does not prescribe any particular analytical, nonclinical or clinical strategy. The main emphasis of the document is on quality aspects.
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Date of Step 4: 18 November 2004
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
