Abstract:
OBJECTIVE To analyse the core meaning of the new Guidelines for the Control of Visible Particulates in Injections(General Chapter 9016) added to the Chinese Pharmacopoeia 2025 Edition, guide the industry to accurately understand the concept of quality management of the whole life cycle of medicines, optimize the system of controlling visible particulates in injections, and promote the effective implementation of the new standard.
METHODS Based on the background of the drafting of the guiding principles, systematically interpreted the relevant provisions on the sources of visible foreign particulates, detection methods, process control and risk analysis.
RESULTS The guidelines systematically summarized the two types of sources of visible particulates, compared and analyzed existing inspection procedures and methods, and the study refined the concept of “prevention-control-monitoring” as a trinity of the whole life cycle control.
CONCLUSION The formulation of the guiding principles marks a new stage of risk management for the quality control of injection in China, which can effectively improve the level of prevention and control of visible foreign particulates through systematic process control methods and scientific risk analysis tools, provide technical support for the quality control of injection, and safeguard the safety of clinical use of drugs.
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