FDA Posts Q5E Biotech and Biological Products Comparability Guideline

The US Food and Drug Administration (Rockville, MD, www.fda.gov) this week posted the Q5E Guidance for Industry, Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. The International Conference on Harmonization (ICH) recommended the guideline for adoption in November 2004 after it had reached Step 4 of the ICH implementation process.

According to the document, Q5E details FDA’s current thinking and recommendations about assessing “the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product” during development and after approval. The guideline was written to assist manufacturers in providing evidence to ensure that such process changes will not adversely affect the quality, safety, or efficacy of the product.