As the most basic medical means, drugs can not only effectively treat and prevent diseases, but also directly affect the health of users. With the continuous improvement of the number and output of drugs, the quality and safety of drugs are the core tasks of pharmaceutical enterprises that can not be ignored. As an important means to detect the risk of problems, the effect of inspection and detection is affected by many factors, such as personnel, equipment, environment and so on. For this, major pharmaceutical manufacturing enterprises have the obligation to perform their duties and strengthen drug quality detection. In the context of the rapid development of science and technology, automation technology, information sharing platform, real-time monitoring system and so on have provided strong support for the development of drug inspection. Data integrity runs through the whole process of drug inspection. It is an internal demand and an inevitable trend to pay attention to the construction of drug research and development laboratory information management system (LIMS). Based on this, starting from the background of drug research and development stage, this paper explores the construction and design content of drug inspection LIMS, and puts forward corresponding construction strategies on how to improve the quality management level of drug research and development, in order to provide exchange and reference.

ABSTRACT: In the setting of escalating international trade, distinct variances emerge in the prerequisites for the quality and safety benchmarks of modified starch across different countries and regions. Taking distarch phosphate as an example, this article compares and analyzes the similarities and differences in relevant standard technical indicators and testing Methods between China and major trading regions or countries such as JECFA, the European Union, the United States, Japan, and South Korea, providing technical support for the international trade of modified starch.

The application of the 7S concept in the construction of metrology laboratories and their standardized management can significantly enhance organizational effectiveness, guarantee experimental accuracy, enhance safety awareness, and through continuous improvement to achieve lasting job satisfaction and performance optimization, which is a necessary condition for the realization of high-efficiency, high-quality laboratory operations. This paper is aimed at measuring laboratory construction and standardized management of the 7S concept of the integration of strategies to carry out research, aims to explore the construction of measuring laboratories, standardized management of how to achieve the development of management programs based on the $7\mathrm{\;S}$ concept through case studies. Only in this paper, for China’s measurement laboratory construction units to learn and reference.

"Method" is one of the five elements of total quality management. In the inspection and testing laboratory, "method" refers to the method used in the whole process of testing. Laboratory information management system can combine scientific laboratory management theory and computer technology organically, and provide advanced technical support for the overall improvement of laboratory management level. This paper combined the "method" of the five elements of quality management with the laboratory information management system, conducted in-depth discussions from three aspects: Standard management, electronic original record management and quality system document management, and verified that the laboratory information management system could assist managers to discover and control the key factors affecting the inspection quality, so as to achieve quality improvement and self-perfection of the quality system. Improve the competitiveness of the laboratory.

Objective To analyze and identify a strain numbered sznj2009. Methods A strain of sznj2009 was isolated from aquatic products, and the colony morphology, biochemical characteristics and biological characteristics of the strain were analyzed and identified. Results The strain showed round, smooth, small colorless colonies on the Vibrio chromogenic plate; Round, flat yellow colonies with opaque centers but transparent edges on CC and mCPC plates; Round, milky white colony on 3% sodium chloride tryptone soybean agar plate. By 16s rDNA sequence analysis found that the strain and vibrio harveyi (ATCC33843) closer, high homology, the evolution of the similarity of 100%. Conclusion The strain sznj2009 isolated from aquatic products was Vibrio harveyi. In the traditional biochemical identification and detection of Vibrio vulnificus, through comparison, it is found that Vibrio harveyi is similar to Vibrio vulnificus in colony characteristics and biochemical characteristics, however, the two strains can be clearly distinguished in the plate and biochemical reaction of Vibrio vulnificus, which can improve the identification accuracy of Vibrio vulnificus and provide reference for the traditional isolation and identification of Vibrio harveyi.

Objective The aim of this study is to investigate the variation of SERS effect intensity with the distance between probe molecules and the enhanced surface using atomic layer deposition (ALD) technology. Methods The study used ALD technology to deposit two-dimensional materials with different thicknesses on the surface of SERS to block raman probe molecules from the surface, exploring the weakening effect of different interaction distances on the SERS effect of the surface, and studying the changes in raman spectral intensity of probe molecules;the study used a silver-silicon combination as the SERS substrate, and a crystal violet aqueous solution with a concentration of ${10}^{-4}\mathrm{\;{mol}}/\mathrm{L}$ as a raman probe to conduct SERS effect exploration experiments on two-dimensional materials with different thicknesses. Results The final experimental results prove that the liquid SERS spectral intensity at the ${532}\mathrm{\;{nm}}$ laser wavelength generally weakens with the increase in the thickness of the two-dimensional material. Conclusion 5 nm thickness is its limiting distance.

Objective To build capability verification public service platform based on the proposed recommendation algorithm. Methods Using big data and artificial intelligence related technologies, after the preprocessing of the ability verification data over the years, the recommendation algorithm model of the supply and demand matching between the provider and the participant is established and trained. After the training meets the requirements, the recommendation accuracy of the algorithm is verified in the core business process of the ability verification. Further explore the needs of all parties in the field of capability verification, integrate the resources of all parties in the field of capability verification, and build a national public service platform for capability verification by using unified data specification, unified business process and unified business description method. Results By using this algorithm model, the supply and demand matching of the providers and participants in the capability verification service on the platform has a better fit than other platforms without using the algorithm. Conclusion The construction of the public service platform for capability verification based on recommendation algorithm

Objective: To achieve rapid on-site detection of benzoic acid and sorbic acid, two common preservatives in cosmetics, and improve detection efficiency and on-site detection capabilities. Methods: A portable Raman spectrometer which used silver nanoparticles as the enhancement substrate for surface enhanced Raman spectroscopy (SERS) was used to detect benzoic acid and potassium sorbate in cosmetics. Results: Benzoic acid and sorbic acid had characteristic Raman peaks at ${1157}{\mathrm{\;{cm}}}^{-1}$ and ${871}{\mathrm{\;{cm}}}^{-1}$,respectively. Further research showed that the concentrations of benzoic acid and sorbic acid were linearly correlated with the intensity of their characteristic Raman peaks, making quantitative detection possible. This was confirmed by traditional liquid chromatography, and the quantitative results were consistent. Conclusion: This SERS method has the advantages of simplicity, speed, and efficiency, and is expected to achieve rapid on-site detection of preservatives.

Objective The accuracy of the test results was evaluated by the interlaboratory comparison of the blind samples, and the test quality and test ability were improved. Methods According to the “National Standard for Food microbiology inspection of food safety” and other Methods for the 2012-2023 assessment of blind samples for testing. Results During the 2012-2023 Blind examination in Yizheng’s CDC Microbiology Laboratory, 3 strains of Enterocoliform Yersinia, 5 strains of Bacillus cereus, 4 strains of Klebsiella (E. sakazakii) and 2 strains of Enterobacter cloacae were detected, 3 strains of Enterobacter aerogenes, 3 strains of Streptococcus hemolyticus, 1 strain of Streptococcus $A,2$ strains of Streptococcus $B,3$ strains of salmonella,1 strain of salmonella enteritidis, 2 strains of Salmonella enterica, two strains of Liszt. Escherichia coli, Shigella, Citrobacter freundii, Pseudomonas aeruginosa, Vibrio alginolyticus, Vibrio vulnificus, Vibrio parahaemolyticus, Staphylococcus epidermidis. Conclusion From 2012 to 2023, all the results were correct, and the combination of manual and instrument can improve the detection capability and quality of the laboratory.

Objective To verify whether the laboratory can accurately detect fluoroquinolone residues in aquaculture products according to standard Methods. Methods In this article, according to the Methods of Determination of 17 Sulfonamides and 15 Quinolones Residues in Aquatic Products by Liquid Chromatography-Tandem Mass Spectrometry (Ministry of Agriculture Announcement No. 1077-1-2008) and Laboratory Quality Control Specifications for Food Physical and Chemical Testing (GB/T 27404-2008), the method validation of the determination of 5 fluoroquinolones residues in cultured aquatic products by Liquid Chromatography-Tandem Mass Spectrometry was carried out, including linearity range, method sensitivity, accuracy and precision. Results The results showed that the 5 target compounds had good linear relationships in the range of $0 \sim {100\mu}\mathrm{g}/\mathrm{{kg}}$ , with correlation coefficients above 0.99 . The method sensitivity (detection limit, quantification limit) met the method requirements, the average recovery rate was ${93.0}\%\sim {110}\%$ , and the relative standard deviation was $\leq {15}\%$ , all of which met the method requirements. Conclusion It indicates that the laboratory can correctly apply this method for detection work under the existing detection conditions.