On-site Inspection Guidance for Inhaled Medicines
Request On-site Inspection Guidance for Inhaled Medicines
  • Local Title:吸入制剂现场检查指南
  • Country/Region:Chinese Mainland
  • Competent Authority: Center for Food and Drug Inspection (CFDI) of NMPA
  • Type:Guideline
  • Status:In force
  • Release Date:2023-03-06
  • Implementation Date:2023-03-06
Language Source Title Access
ZH Official 吸入制剂现场检查指南 Download

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.