The animal laboratory of pharmaceutical and biological product inspection and testing institutions undertakes important basic support tasks for testing and scientific research work.This article summarizes the management experience accumulated in the operation of our institution's CNAS-CL06 quality management system,providing reference for similar institutions in operation to ensure the scientific nature of animal experimental data.In order to ensure the scientific nature of animal experimental data,the experimental animal institution has successfully passed the CNAS accreditation of the experimental animal institution,and has completed rectification on time during on-site supervision and evaluation.At the same time,regular self inspections of the system have been carried out in accordance with the"Quality and Capability Accreditation Guidelines for Experimental Animal Breeding and Use Institutions"(CNAS-CL06).During the self inspection process,we examined issues while improving the content of the system.Starting from animal procurement,occupational health and safety,animal disease treatment and care,and facility operation emergency drills,we enriched the content of the quality management system,ensured the continuous and effective operation of the system,and ensured the effectiveness and standardization of animal experiment data.At the same time,we contributed to the management ideas of our institution in sharing animal experiment platforms,provide hardware and software support for the construction of cloud platforms for animal experiments.This article aims to explore and form a quality management model for the experimental animal industry based on practical work,being focused in the standardization strategy,continue to deepen the reform of standardization work,and give full play to the basic and strategic role of standardization in the modernization of the animal experiments system.

Science and technological advancements drive human progress, with laboratory animals serving as essential resources for developments in life sciences and medicine. However, the waste generated by these animals presents new challenges for urban management. Issues such as classification, recycling, effective utilization, and biohazard elimination must be addressed, necessitating the development of regulations, standards, and norms to keep pace with advancements. The construction of quality management system is the foundation and framework for the management of inspection and testing organizations. It should have strong operability and inspectability, enabling continuous improvement of the management level and enhancing the stability of basic management. However, current quality management systems often lack clarity in managing laboratory animal waste, including undefined disposal processes for non-medical institutions, inaccurate waste classification, and inadequate disposal methods for different waste categories. This paper addresses these challenges by identifying necessary processes to be added or removed in the quality management system of National Institutes for Food and Drug Control, developing effective SOPs, proposing practical measures to strengthen supervision and management, and integrating 6S management principles into our quality management system. In conclusion, effective management of laboratory animal waste should be centered on improving the quality management system, emphasizing waste classification and management at the source, controlling biological hazards, minimizing environmental pollution and promoting conditions for sustainable development.

Diabetic patients with poor glycemic control are exposed to media containing mold spores, and spores enter the body, which may lead to refractory infections. This article combines case and literature reviews, proposes the diagnosis and treatment method of mold infection, and provides some guidances for subjects who long-term exposure to mold groups such as farmers and immunocompromised people.

Objective To study the relationships between differences in tumorigenicity and immu-nogenetic backgrounds of nude mice. Methods According to the Chinese Pharmacopoeia, positive and neg-ative groups were set up in both Laboratory A and B with ten nude mice in each group. Organ tissues were collected for clinicopathological analysis. Blood samples were collected and detected using flow cytometry. DNA was extracted and analyzed with 23 STR markers. Results The positive group of Laboratory B was in-valid (7/10 tumor formation). The two laboratories showed no significant difference in the results of patho-logical analysis, but had significant differences in CD25, CD8, CD4, Th1 and Th2. There were 13 and 18 polymorphic sites respectively found in nude mice of Laboratory A and B. Further analysis of the non-tumor-bearing nude mice in Laboratory B positive group revealed that CD25, Th2, D3Mit29 and D5Mit48 were the specific indexes. Conclusion Differences in tumorigenicity might be related to the diversity of immunoge-netic backgrounds of nude mice.

Objective To analyze the result of proficiency testing(PT)of detection activities for Laboratory animal pathogenic bacteria in 2011 and 2013-2017. To further improve the detection capacity of laboratory animal testing agency,and promote PT to be carried out in future. Methods During the six years(2011 and 2013 -2017), the National Institutes for Food and Drug Control conducted a total of six(seven projects)PT activities of laboratory animal pathogen bacteria. We analyzed the overall trend and the exposed problems by summarizing the result data of the PT in 6 years. Results A total of 45 laboratories in the country including 20 provinces and cities participated in the PT. The PT projects included Mycoplasma pulmonis, Clostridium piliformis, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella spp.,Klebsiella pneumoniae and Bordetella bronchiseptica. The satisfaction rates were 75%,87.5%,80.0%, 78.6%,93.3,96.2% and 88.0%, respectively. The main reasons of unsatisfactory results were for lack of incubation time,select errors of suspicious bacteria, biochemical identification errors, report writing errors and not timely feedback results. Conclusions The level of domestic laboratory animal pathogenic bacteria detection is gradually increased to achieve the desired goal through continuous proficiency testing activities.

Objective To establish and preliminarily apply an effective PCR assay for detection of Tupaia(tree shrew)paramyxovirus(TPMV). Methods Using TPMV genomic DNA from NCBI GenBank, bases 8231 to 8720 were synthesized and inserted into a plasmid as a positive standard. One primer pair was designed based on this sequence. In total,60 respiratory swabs and 12 lung tissues from the tree shrews were tested in this PCR assay. Results A PCR method for detection of TPMV was successfully established,with high specificity and sensitivity of 11.5 × 10 -5μg/mL. PCR result testing 60 respiratory swabs and 12 lung tissues were negative. Conclusions PCR for detecting TPMV has good specificity and high sensitivity and can be used for conventional tree shrew paramyxovirus detection.

Objective We established a rapid detection method of Pasteurella spp.and provided a reference for microbiological quality control of laboratory animal .Methods According to the β subunit of bacterial RNA polymerase ( rpoB) protein multiple alignments of 13 different Pasteurella spp.published in NCBI .The degenerate primers were designed by CODEHOP designer online .CODEHOP PCR method was applied to detecting Pasteurella spp.after the specificity and sensitivity of the method had been evaluated by 21 reference strains .Results Standard strain amplified fragment were about 200 bp by degenerate primers PastF6/PastR5.The primers are able to distinguish between Pasteurella spp.and the other pathognic organisms of laboratory animal respiratory tracts .Sensitivity of this method were 0.2 pg/μL~2 pg/μL to different Pasteurella.The Pasteurella positive rate was 19.1% in 609 animal ' s respiratory samples .The accuracy of positive results was 100%through verifying by sequenced and blast .Conclusions The established method has good specificity and sensitivity .It can be used to detect Pasteurella spp.in animal samples .

Objective To establish a detection technique for H.pylori(HP) infection in Mongolian gerbils using nested PCR technique.Methods H.pylori was cultured in vitro and inoculated into Mongolian gerbils.At the 10th week after infection, the HP in the gastric juice of Mongolian gerbil was detected by conventional PCR assay and the gastric juice, gastric mucosa, duodenal contents and colon stool were examined by nested PCR.Rapid urease test and ELISA were used to analyze the accuracy of the nested PCR assay.All of the PCR products were verified by sequencing.Results The positive rate of gastric juice detected by conventional PCR was 30%, while the positive rates of gastric juice, gastric mucosa, duodenal contents and colon stool detected by nested PCR were 100%, 100%, 90%, and 10%, respectively.The positive detection rates of rapid urease test and serum ELISA were 100% and 0%, respectively.Comparing the results of different methods, both the positive rates of gastric juice and gastric mucosa detected by nested PCR and the detection rate of rapid urease test were 100%, but the results of conventional PCR detection of gastric juice, the nested PCR detection result of stool in colon and of serum ELISA assay were lower than other methods.Conclusions Due to its high accuracy and sensitivity, the nested PCR assay of gastric juice can be used for the long-time detection of H.pylori infection in Mongolian gerbils, especially useful in the experiments of prevention and treatment of H.pylori infection.

Objective To strengthen the quality control management and enhance the detection capacity of the experimental animal quality control laboratoriesin our country through the detection of serum esterase-1 (Es-1) in the experimental mice.Methods The samples were prepared according to the standard procedure, and then were randomly numbered and distributed to participating units by cold-chain transport.Before the deadline, the participants submitted the results and the copies of original records.When the results were completely consistent with the standard results,the results were regarded as satisfactory, otherwise were unsatisfactory.Results A total of 11 laboratories participated in this program, of which 10 laboratories were regarded as satisfactory (90.9%) and one laboratory obtained unsatisfactory result (9.1%).Conclusions The results of this proficiency testing project demonstrate that the overall detection level of Es-1 in laboratory mice is highof the participating laboratories.However, more attention still should be paid to standard specifications and some test details.

Objective To understand the characteristics of minipigs infected withJapanese encephalitis virus(JEV).Methods After the brain tissues were treated, the pig brain tissue treatment solution was inoculated with BHK21 cells.Then, virus culture,indirect immunofluorescence assay, neutralization test, electron microscopic observation, and reverse transcription-polymerase chain reaction (RT-PCR) amplification of the new isolate E segment and PrM segment nucleotide sequence were performed and the genotype was identified.Results BHK21 cells were inoculated into 25 pigbrain tissues.Among them, three tissue-treated fluid couldinduce shrinkage and aggregation of BHK21 cells, and immunofluorescence staining showed strong green fluorescence response.The results of neutralization test showed that the neutralization titer of these three new isolates was 1:64, and the size of the virus particles was about 40nm under the electron microscope.The homology of both RT-PCR product sequencing results and E-segment of vaccine strain were 95%.Three new isolates were type GIII JEV.Conclusion The results ofthisstudydemonstrate that there is G III type Japanese encephalitis virus infection in the minipig farm.