Objective: To develop a standardized Burkholderia cepacia complex (referred to as “Bcc”) testing method for the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, thereby enhancing the national standards for China's pharmaceutical microbial contamination control and improving regulatory oversight. Methods: A systematic methodological evaluation of Bcc detection protocols was conducted by referring to the international standards for pharmaceuticals, cosmetics, and related products. By collaborating with 11 drug control laboratories under a national pharmaceutical standards enhancement initiative, critical parameters were optimized, including enrichment conditions, selective media, and confirmatory assays. Methodvalidation was performed using both spiked and real-world samples, followed by iterative revisions based on interlaboratory verification. Results: The reference strains for quality control, an optimized enrichment and isolation system, and selective culture media with improved specificity were specified in the finalized Chinese Pharmacopoeia 2025 Edition Bcc test method. Additionally, a definitive species-level taxonomic list of Bcc members was incorporated to facilitate accurate strain identification. Conclusion: On the basis of aligning with global regulatory standards, the establishment and inclusion of the Bcc test method addresses critical gaps in China's pharmaceutical microbiological quality control. Its adoption in the Chinese Pharmacopoeia 2025 Edition represents a pivotal advancement in the compendium's microbial standards, ensuring enhanced detection of opportunistic pathogens in pharmaceutical products.

Objective: To strengthen the implementation of the main responsibility for microbial control of pharmaceutical water, and to enhance the guidance on the full life cycle microbial monitoring and control of pharmaceutical water in the industry, the “Guideline for Microbiological Monitoring and Control of Pharmaceutical Water” was established. Methods: Four institutes for drug inspection and many pharmaceutical manufactures were organized to sort out the key points of the guideline through the investigation of testing methods, exploration of the application of rapid microbial methods, comparison of regulations and standards, questionnaire surveys, and on-site investigations of enterprises. Results: A full-chain technical framework covering the microbial characteristics, monitoring methods, process control, and risk prevention and control of pharmaceutical water was constructed Chinese Pharmacopoeia 2025 Edition has newly added the “Guideline 9209 for Microbiological Monitoring and Control of Pharmaceutical Water”. Conclusion: This guideline is an important supplement to the revision and implementation of product standards and general rules for pharmaceutical water, and also represents a significant measure for aligning Chinese Pharmaceutical water standard system with international advanced technical concepts.

Objective: To address the deficiencies in the selection, validation, and application of disinfectants by pharmaceutical manufacturers, and in line with the core concept of “whole-process control” in the Chinese Pharmacopoeia (referred to as the “Chinese Pharmacopoeia”) 2025 Edition, to establish a scientific and operational guideline for the evaluation of disinfectant efficacy. Methods: By integrating domestic and international pharmacopoeia standards (USP, JP) and national standards (GB/T series), technical specifications were systematically formulated, covering the classification of disinfectants, methods for efficacy evaluation, and criteria for result determination. Results: The application scope of chemical disinfectants in the pharmaceutical environment was clarified, and two test methods, the suspension method and the carrier method were listed, and the threshold for determining disinfection efficacy was set based on international standards (a reduction of ≥3 in the lg value for bacterial or fungal vegetative cells, and a reduction of ≥2 in the lg value for spores or spores). Conclusion: The establishment of this guideline has promoted the improvement of the microbial contamination control standard system and provided technical support for the microbial safety management in the pharmaceutical production process.

Objective: To provide references for further optimizing the National Drug Quality Sampling and Testing process management strategies by comparing the checklist requirements and recommended procedural framework of the Market Surveillance and Control (MC) module in the GBT assessment tool. Methods: The literature research method was adopted to summarize the checklist requirements and recommended procedural framework of the MC module in the GBT assessment tool, and key risk factors according to the proposed targeted process management optimization strategies of the National Drug Quality Sampling and Testing program were analyzed. Results: Comprehensive analysis revealed that 17 indicators were highly relevant to the National Drug Quality Sampling and Testing program, covering six aspects including legal and regulatory framework construction, organizational management structure, human resource management, procedural document management, system and data management, and risk communication and information disclosure. The analysis of the MC module shows that a good post-market quality surveillance framework should have a regulatory framework and work procedures covering the entire process from sampling, testing research, to risk assessment and mitigation; establish a clear and stable, well-defined organizational structure and be able to form regulatory decisions comprehensively and objectively; construct a personnel management and training system conducive to the implementation of post-market quality surveillance activities; build a database management platform covering the entire process of surveillance, providing trend analysis and regulatory tools to guide the prevention and control of counterfeit and substandard medical products, as well as assessment indicators tailored to different functional requirements, and simultaneously form an international risk information sharing and collaborative disposal system. Conclusion: As a specific form of post-market quality surveillance activities, the National Drug Quality Sampling and Testing program, by further refining the process management system in accordance with the above framework requirements, is conducive to forming management standards and risk management pathways with international compatible. This, in turn, enables a more profound participation in global safety governance. It is suggested to strengthen online sampling and expand international cooperation at the regulatory framework level; establish a sound decision-making consultation system in terms of organizational management structure; construct a training effect evaluation mechanism in terms of human resource management; build and enrich trend analysis tools in terms of system and data management; and enhance the communication, and reinforce an international risk information sharing and collaborative disposal system in terms of risk communication and information disclosure.

Objective: By statistically analyzing the deficiencies found in routine inspections of non-compliant drug wholesale enterprises and retail chain headquarters in Guizhou Province within three years after the implementation of the “Drug Inspection Management Measures (Trial)”, this study aims to identify common issues and risk points, propose corresponding measures and suggestions, and provide references for drug supply enterprises to standardize operations and for regulatory authorities to better control risks in the drug circulation process and develop more targeted supervision strategies. Methods: A retrospective statistical analysis was conducted on the deficiencies identified in 43 non-compliant enterprises during routine inspections in Guizhou Province from 2022 to 2024. The key problematic areas were identified and analyzed. Results: A total of 440 deficiencies were recorded, including 40 critical deficiencies, 235 major deficiencies, and 165 minor deficiencies. High-frequency deficiencies were primarily concentrated in areas: quality management system documentation, storage and maintenance, organizational and quality management responsibilities, personnel and training, and facilities and equipment, accounting for 60% of the total deficiencies. Conclusion: Enterprises should continuously enhance legal and safety awareness, strengthen primary responsibility in operations, improve quality management systems, reinforce personnel training and facility management, and meet hardware requirements. Regulatory authorities should intensify the dissemination of laws and regulations, promote collaborative social supervision, expand professional teams through resource coordination, form regulatory synergy, and innovate supervision methods to improve precision and effectiveness.