T/CNPPA 3002-2018 Technical Guidelines for Peritoneal Dialysis Solution Packaging Systems
T/CNPPA 3002-2018
Basic Information
Scope
Main technical content: Peritoneal dialysis, as an effective method of blood purification, is characterized by simple operation, low medical cost, and easy popularization and application. It plays an irreplaceable role in improving the survival rate of uremia patients in China. Due to the characteristics of peritoneal dialysis treatment itself, its dependence on the packaging system is relatively high, so the packaging system has a significant impact on the drug quality of peritoneal dialysis solution and the treatment effect of patients. This guideline aims to guide enterprises to continuously improve from design and R&D, production, quality control, technical requirements, compatibility studies to storage and transportation. Production units and user units should provide sufficient guidance on product use to ensure patient medication safety, improve patient operation convenience, and enhance patients' quality of life.