Quality guidelines
date: 13/02/2024
The following guidelines will come into effect on 14 June 2024:
- An ICH Q5A(R2) guideline on the evaluation of viral safety of biotechnology products derived from cell lines of human or animal origin. It provides guidance on viral clearance and testing data to be submitted in marketing applications.
- An ICH Q2(R2) guideline on the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure Development. It provides guidance on the selection and evaluation of the various validation tests for analytical procedures and applies to new or revised analytical procedures used for release and stability testing of commercial drug substances and products (chemical and biological/biotechnological).
- An ICH Q14 guideline on analytical procedure development. It describes science and risk-based approached for developing and maintaining analytical procedures suitable for the assessment of the quality of drug substances and drug products. It complements ICH Q2 on validation of analytical procedures.
The following documents were released for consultation:
- A draft concept paper on the development of a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the treatment or prophylaxis of bacterial infections or infectious diseases ; until 31 March 2024 .
- A joint CHMP/CVMP guideline on the development and manufacture of synthetic peptides addressing aspects on the manufacturing process, characterisation, specifications and analytical control for synthetic peptides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017); until 30 April 2024.
The following Q&A documents have been published: