ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 18.5: Run viral removal and inactivation steps within validated parameters and prevent virus carry-over by segregation, separate air handling and cleaning

What does 18.5 require?

For some processes viral removal and inactivation are critical steps and should be run within their validated parameters (ICH Q5A gives more detail). Precautions should prevent viral contamination passing from pre- to post-removal or inactivation steps, so open processing should be done in areas separate from other processing with separate air handling. Different purification steps do not normally share equipment; if it is, it should be properly cleaned and sanitised before reuse, with precautions against virus carry-over through equipment or environment.