Foundation

Fundamental basis

The foundation for cleaning validation requirements is outlined in ICH Q7, Good Manufacturing Practice Guidelines for Active Pharmaceutical Ingedients, section 5.2. This section includes requirements for written procedures for the cleaning and release of equipment, details to enable operators to perform the cleaning in a reproducible and effective way, appropriate cleaning and storage of cleaned equipment and utensils, prevention of build-up and objectionable (harmful) bacteria over the course of continuous production, cleaning of non-dedicate equipment at changeover, rationale for cleaning procedure and cleaning agents, and requires the appropriate meassures to be taken to determine the cleanliness of equipment.