ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 18.4: Harvest and purify in equipment and areas that minimise contamination, with procedures that consistently remove the organism, debris and media, clean equipment after use and add controls for multi-product use

What does 18.4 require?

Harvesting, whether to remove cells or components or to collect components after disruption, should take place in equipment and areas designed to minimise contamination. Harvest and purification steps that take out or inactivate the production organism, cell debris and media while limiting degradation, contamination and quality loss should recover product of consistent quality. All equipment should be cleaned and sanitised as appropriate after use; multiple successive batches without cleaning are acceptable only if quality is not compromised. Open-system purification should be done under environmental conditions that preserve quality, and extra controls such as resins kept for one product or added testing may be needed where equipment serves several products.