五月 22, 2024
How to Meet Container Closure Integrity (CCI) Requirements of ChP 2025
To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China(NMPA)published the guidance “Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections” (21 October 2020), which indicates the beginning of injection consistency evaluation. This guidance clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc. <br />Container Closure Integrity (CCI) is one of the key factors for the quality and safety of the entire product lifecycle of pharmaceuticals. To better address this topic, NMPA issued “Technical Guide for Research on Package Integrity of Chemical Injections (Trial)” on 21 October 2020. And 4 years later, “9650 Guidelines for Research on Pharmaceutical Package Integrity” is published as Chinese Pharmacopoeia (ChP) 2025 chapter on 19 Feb 2024. This new publicity helps to guide the implementation of CCI of pharmaceutical packaging materials and provides effective ways to comprehensively assure the quality of drugs.
Qian Liu
Senior Technical Account Specialist, Generics