Manufacturing process validation what’s next?

After publication of the US-FDA Process Validation Guideline in 2011, the EMA’s Biologics Working Party earlier this year published a draft Guideline on Process Validation for the manufacture of biotechderived active substances. The agency’s Quality Working Party has also released its guideline on process validation, which focuses on finished dosage forms for new chemical entities, and stated that the principles also apply to biologic products. Finally, the EMA’s GMP/GDP Inspectors Working Group recently published its revised Annex 15 of the EU GMP Guidelines for Medicinal Products. As previously outlined in ICH Q7, Q8 and Q11, all…