Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:

Jan 7, 1996 · 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.

Jun 14, 2024 · This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package. Keywords: Viral safety, cell lines qualification, biotechnology, virus clearance.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …

Therefore, considerations for further risk reduction (e.g., treatment of raw materials, extensive testing for broad virus detection) should be applied (see Annex 6).

The guidance stated in the ICH Harmonised Tripartite Guideline ‘Stability Testing of New Drug Substances and Products’ (27 October 1993) applies in general to biotechnological/biological products.

The ICH Q5A(R2) guideline establishes harmonized scientific and technical requirements for products derived from characterized cell lines of human or animal origin:

ICH Q5C intends to give guidance to applicants regarding the type of stability studies to be provided in support of marketing authorisation applications for biological medicinal products. polypeptides isolated or manufactured by rDNA technology. studies. The design of the long-term stability program is critical.

ICH Q5A(R1) was finalized in 1999 •Concept paper and business plan endorsed in 2019 •Revision signed off in September 2022 (Step 2) •Issued by the ICH Regulatory Members for public...

Oct 26, 2022 · In October, the EMA published a revised version of "ICH: Q 5 A (R1): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin" for consultation.