Objective:To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia(ChP)2025 Edition,and explore its novel requirements in risk-based pharmaceutical product lifecycle management.Methods:A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview,international harmonization of microbiological standards,risk-based quality man-agement system,and novel tools and methods with Chinese characteristics.Results:The ChP 2025 edition demon-strates three prominent features in microbiological-related standards:enhanced international harmonization,intro-duced emerging molecular biological technologies,and established a risk-based microbiological quality control sys-tem.Conclusion:The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system,which significantly improves the scientificity,standardization and applicability of the standards,providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

The microbial limit standards in the Chinese Pharmacopoeia 2020 edition primarily focus on total aerobic microbial count and specified objectionable microorganisms,which are insufficient for comprehensively assessing the potential risks posed by microbial contamination to drug efficacy and patient safety.With the increasing com-plexity of rising regulatory requirements,there is an urgent need to establish a scientific and systematic microbial risk assessment and control framework.In response,the Chinese Pharmacopoeia 2025 edition,introduces a new general guideline 9212 Risk Assessment and Control of Unacceptable Microorganisms for Non-sterile Products.This chapter systematically constructs a framework for the identification and control of risks associated with unacceptable microorganisms,filling a gap in the relevant field within international pharmacopoeias.This article systematically elaborates on its key elements based on its core framework and content.It covers the development background,core concepts,testing and identification strategies,evaluation of risk characterization factors,formulation of risk control measures,and implementation pathways.The aim is to provide pharmaceutical enterprises and regulatory agencies with systematic and clear practical guidance.

The Chinese Pharmacopoeia 2025 Edition added the 9213 Guideline for validation,verification,and transfer of microbiological analytical methods.Based on the characteristics of pharmaceutical microbiological analyt-ical methods and practical applications,it specified definitions of relevant terms and application scenarios,estab-lished technical indicators and acceptance criteria for methodological evaluation,and introduced key statistical tools and evaluation principles.This article systematically elaborates on the drafting background and process of the Guideline,and interprets its key content,aiming to offer theoretical guidance and practical reference for relevant practitioners in applying this guideline.This guideline strengthens the foundation of pharmaceutical microbial analytical methods in China and enhances the scientificity and accuracy of the pharmaceutical microbial standards system.

Whole Genome Sequencing(WGS)technology,leveraging its significant advantages in precise microbial identification and traceability analysis,has become a core tool in international pharmaceutical microbial quality control.The release and implementation of the Guideline 9110 for Microbial Whole Genome Sequencing Technology in the Chinese Pharmacopoeia 2025 Edition marks the official entry of China's pharmaceutical microbial quality con-trol into the genomic era.Guideline 9110 establishes universal technical specifications for the application of WGS technology in pharmaceutical microbial quality control,covering laboratory general requirements,key technical parameters,technical workflow,major factors affecting sequencing results,method validation,and application guidance.This article focuses on the background of the standard's development and its technical rationale,provi-ding a systematic interpretation of key technical indicators,the scope of application,and essential points for techni-cal implementation.It aims to offer theoretical guidance and practical references for the industry in applying WGS technology.

Objective To predict the quality marker(Q-marker)of Wuwei disinfection decoction based on HPLC fingerprints and network pharmacology.Methods Using the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2012 version)software,the fingerprints of 15 batches of Wuwei disinfection decoction were established,and the peaks were found and assigned to each batch.Wuwei disinfection decoction's primary targets and routes were screened using network pharmacology,and a"component-target-pathway"network diagram was established.The five principles of the Q-marker were used to predict the quality marker in Wuwei disinfection decoction.Results The similarity of the fingerprints of 15 batches of Wuwei disinfection decoction was＞0.95,13 peaks were identified,and 11 peaks were recognized as neochlorogenic acid,chlorogenic acid,esculetin,cryptochlorogenic acid,loganin,secoxyloganin,chicoric acid,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C and linarin.Through the pharmacological analysis of the network,it was speculated that chlorogenic acid,esculetin,secoxyloganin,chicory acid,and linarin might be potential Q-marker of Wuwei disinfection decoction,which may regulate multiple genes,such as tumou suppressor p53/oncoprotein Mdm2,tyrosine-protein kinase SRC,as well as multiple cancer pathways such as pancreatic cancer and prostate cancer,to produce anti-tumor and anti-cancer effects.At the same time,Wuwei disinfection decoction was also predicted to be used for the treatment of COVID-19.Conclusion The established HPLC fingerprinting method of Wuwei disinfection decoction was sensitive,rapid,and stable.Based on the network pharmacology results,potential Q-marker with traceability,predictability,and close relevance to the clinical application of Wuwei disinfection decoction was screened,which can provide a reference for further research on Wuwei disinfection decoction in the future.

ObjectiveTo evaluate the proficiency and consistency of domestic and foreign testing institutions in the field of veterinary drug residue detection in food， and to promote international cooperation and mutual recognition of testing results among these institutions. MethodsA robust statistical analysis was conducted on the testing results of 20 laboratories in eight countries and regions across North America， Europe， and Asia. The laboratories’ testing capabilities were evaluated using Z-score comparison. ResultsAmong the 20 participating laboratories， 18 achieved satisfactory results， resulting in a satisfaction rate of 90%， while 2 laboratories （10%） failed to meet the requirements. The satisfaction rate of domestic laboratories （100%） was higher than that of foreign laboratories （81.8%）. ConclusionDomestic laboratories perform better than overseas laboratories in determining veterinary drug residues in food. To enhance testing capabilities， these overseas laboratories with unsatisfactory evaluation results should strengthen their daily quality control and ensure traceability of original records.

Objective To investigate the microbial contamination in 54 batches of commercial honey. Methods Aerobic plate colony counts for bacteria and colonies of mould and osmophilic yeasts in honey were determined according to the National Food Safety Standard. The bacteria and fungi in unqualified samples were further identified and analyzed by morphology， MALDI-TOF-MS and large subunit （LSU） rRNA gene sequence. Results Three unqualified batches were found. One batch had aerobic plate colony counts exceeding the standard， with a variety of bacteria including Bacillus sp.， Paenibacillus sp. and Brevibacillus sp. Two batches had mould counts exceeding the standard. Aspergillus sp was detected in both samples （from the same manufacturer）， and the DNA sequence homology was very high， suggesting the mould might come from the same pollution source. Conclusion There are many kinds of microbial contamination in honey. Manufacturers should strengthen the microbe control in monitoring process to avoid the repeated microbial contamination.