ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 5.2: Maintain equipment preventively and clean it under detailed written procedures with justified residue limits, status labelling and controls against carry-over

What does 5.2 require?

Schedules and procedures, with assigned responsibility, should be set for preventive maintenance. Written cleaning procedures should be detailed enough for an operator to clean every equipment type reproducibly and effectively, covering responsibility, schedules including sanitising, methods and materials including dilution of agents, disassembly and reassembly instructions, removal of previous batch identification, protection of clean equipment before use, inspection for cleanliness just before use where practical, and the maximum time between end of processing and cleaning where relevant. Equipment and utensils should be kept clean, stored properly and sanitised or sterilised where needed to prevent contamination or carry-over. Equipment used for continuous or campaign production of one product should be cleaned at intervals that prevent build-up, and shared equipment cleaned between different materials. Residue acceptance criteria and the choice of procedures and agents should be defined and justified. Equipment should show its contents and cleanliness status.