ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 18.1: Control every stage of cell culture and fermentation APIs: appropriate prior steps, environmental controls matched to open or closed processing, process controls for cell banks, culture, harvest, bioburden and viral safety, and demonstrated impurity removal

What does 18.1 require?

Suitable controls should apply at all stages to assure quality, and steps before the guide's starting point, such as cell banking, should be under suitable process control. Equipment and environmental controls should minimise contamination, with environmental acceptance criteria and monitoring frequency set according to the step and whether the system is open, closed or contained. Process controls should take into account working cell bank maintenance, proper inoculation and expansion, control of critical operating parameters, monitoring of cell growth, viability and productivity where relevant, harvest and purification that remove cells, debris and media while protecting product from contamination and quality loss, bioburden and endotoxin monitoring at suitable stages, and viral safety as described in ICH Q5A. Where appropriate, the process should be shown to clear media components, host cell proteins, process-related and product-related impurities and contaminants.