The guidance is for on-site inspections of inhaled medicines and GMP compliance inspections. 

The guidance summarizes the characteristics of different categories of inhaled medicines and notes the special risks in R&D, technology transfer, and commercialized manufacture. 

Based on the analysis of the critical quality attributes that may affect products’ efficacy and safety, the guidance specifies the key points in terms of active pharmaceutical ingredients (APIs), excipients, drug delivery devices, equipment, manufacturing process, and quality control for inspections of specific categories of inhaled medicines.

The guidance is meant for helping inspectors identify the risk control points and conduct on-site inspections of inhaled medicines.