This article combined the current status of the industry and standards for pharmaceutical composite films and bags,and summarized the relevant content of the guiding principles for the Pharmacopoeia of the People's Republic of China(2025 Edition)on pharmaceutical composite films and bags.It analyzed the production requirements,usage requirements,key quality attributes,and control requirements improvement details,providing reference for assisting relevant parties to understand and use the pharmacopoeia guiding principles,and helping to improve the quality control level of the industry.

Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.

Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.

This article combined the current status of the industry and standards for pharmaceutical composite films and bags,and summarized the relevant content of the guiding principles for the Pharmacopoeia of the People's Republic of China(2025 Edition)on pharmaceutical composite films and bags.It analyzed the production requirements,usage requirements,key quality attributes,and control requirements improvement details,providing reference for assisting relevant parties to understand and use the pharmacopoeia guiding principles,and helping to improve the quality control level of the industry.