Sunday, 13 April 2014

QUALITY GUIDELINES: Biotechnological Products





Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.


Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

Description: The tripartite harmonised ICH Guideline was finalised under Step 4 in March 1997. This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. The purpose is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation 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)).

Implementation: Step 5
EU: Adopted by CPMP, April 1997, issued as CPMP/ICH/295/95
MHLW: Adopted, 22 February 2000, PMSB/ELD Notification No. 329
FDA: Published in the Federal Register, 24 September 1998, Vol. 63, No. 185, p. 51074



Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

Description: The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. It advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

Implementation: Step 5
EU: Adopted by CPMP, December 1995, issued as CPMP/ICH/139/95
MHLW: Adopted January 1998, PMSB/ELD Notification No. 3
FDA: Published in the Federal Register, 23 February 1996, Vol. 61, p. 7006



Stability Testing of Biotechnological/Biological Products

Description: The tripartite harmonised ICH Guideline was finalised under Step 4 in November 1995. This document augments the stability Guideline (Q1A above) 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.

Implementation: Step 5
EU: Adopted by CPMP, December 1995, issued as CPMP/ICH/138/95
MHLW: Adopted January 1998, PMSB/ELD Notification No. 6
FDA: Published in the Federal Register, 10 July 1996, Vol. 61, p. 36466



Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Description: The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

Implementation: Step 5
EU: Adopted by CPMP, September 1997, issued as CPMP/ICH/294/95
MHLW: Adopted 14 July 2000, PMSB/ELD Notification No. 873
FDA: Published in the Federal Register, 21 September 1998, Vol. 63, No. 182, p. 50244-9



Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process

Description: The tripartite harmonised ICH Guideline was finalised 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.

Implementation: Step 5
EU: Adopted by CPMP, December 2004, CPMP/ICH/5721/03
MHLW: Adopted 26 April 2005, PFSB/ELD Notification No. 0426001
FDA: Published in the Federal Register, 30 June 2005, Vol. 70, No. 125, p. 37861-2


Source: International Conference on Harmonisation



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