Study on the establishment and management of GLP in chemical toxicity identification in occupational health institutes / 中国职业医学

@#Abstract: The demand for reliable toxicological data of chemicals runs through every link of occupational health work. The prevention of occupational diseases involves high requirements for the standardization of chemical toxicity assessment in occupational health institutions. Good laboratory practice (GLP) emphasizes the integrity of the test process to trace and supervise the whole process of the test, which is conducive to the standardization of chemical toxicity identification. Therefore, the standardized construction of GLP laboratories is an important starting point for occupational health institutions to carry out chemical toxicity identification. In the construction and management process of GLP laboratories for chemical toxicity identification, occupational health institutions need to build a sound organization and operation system, carry out systematic training and assessment of personnel, establish standard operating norms and emphasize their importance, strengthen the management of facility environment and laboratory, pay attention to quality control and process supervision, and constantly improve their own ability level. To actively adapt to social development and market demand, to provide strong support for occupational health work.

Aseguramiento de Calidad en el Laboratorio de Biología Molecular: Control de Contaminación Ambiental / Quality Assurance in the Laboratory of Molecular Biology: Control of Environmental Contamination / Garantia de Qualidade no Laboratório de Biologia Molecular: Controle da Contaminação Ambiental

La reacción en cadena de la polimerasa (PCR) es la técnica más importante en Biología Molecular. Su principal deficiencia es la susceptibilidad a la contaminación de la muestra, ya sea con productos de amplificación generados en reacciones previas o con material genético proveniente de otras muestras. Se entiende por contaminación a la presencia indeseada de moléculas de ADN o ARN, que pueden actuar como templados en reacciones de amplificación. El objetivo del trabajo fue demostrar la importancia de la implementación de un control de contaminación ambiental periódico monitoreando la integridad del circuito de PCR. Para ello, se hisoparon puntos correspondientes a diferentes áreas de trabajo y se investigó la presencia de amplicones mediante PCR Real Time en Lighcycler 2.0, Roche® y Ampliprep Cobas s201, Roche®. En puntos críticos del circuito (flujo laminar o la cabina de seguridad del área de pre-PCR) no se detectaron amplicones, aunque sí se hallaron en las mesadas y heladeras. En el resto del circuito, la distribución de los amplicones fue variable. De esta forma se demuestra la importancia de la realización de un control de contaminación ambiental periódico en laboratorios que realizan la técnica de PCR, pudiendo detectar contaminación de forma precoz y tomar acciones correctivas a tiempo.

Polymerase chain reaction (PCR) is the most important technique in Molecular Biology. Its main deficiency is susceptibility to contamination of the sample, either with amplification products generated in previous reactions or with genetic material from other samples. Contamination is understood as the undesired presence of DNA or RNA molecules, which may act as annealing in amplification reactions. The objective of this work is to demonstrate the importance of implementing a periodic environmental pollution control by monitoring the integrity of the PCR. To do this, different areas of work were swabbed and the presence of amplicons were investigated by Real Time PCR in Lighcycler 2.0, Roche® and Ampliprep Cobas s201, Roche®. At critical points in the circuit (laminar flow or pre-PCR area booth) no amplicons were detected, although they were found in countertops and refrigerators. In the rest of the circuit, the distribution of the amplicons was variable. Thus, the importance of conducting a periodic environmental contamination control in laboratories that perform the PCR technique is demonstrated, enabling early detection contamination and corrective actions being taken on time.

A reação em cadeia da polimerase (PCR) é a técnica mais importante em Biologia Molecular. Sua principal deficiência é a suscetibilidade à contaminação da amostra, seja com produtos de amplificação gerados em reações prévias ou com material genético em reações prévias ou com material genético proveniente de outras amostras. Entende-se por contaminação a presença não desejada de moléculas de DNA ou ARN, que podem agir como temperados em reações de amplificação. O objetivo do trabalho foi demonstrar a importância da implementação de um controle de contaminação ambiental periódico monitorando a integridade do circuito de PCR. Para isso, se fez esfregaço de pontos correspondentes a diferentes áreas de trabalho e foi investigada a presença de amplicons mediante PCR Real Time em Lighcycler 2.0, Roche® e Ampliprep Cobas s201, Roche®. Em pontos críticos do circuito (fluxo laminar ou a cabine de segurança da área de pré-PCR), não foram detectados amplicons, apesar de serem encontrados nas bancadas e refrigeradores. No resto do circuito, a distribuição dos amplicons foi variável. Assim mostra a importância da realização de um controle de contaminação ambiental periódico em laboratórios que realizam a técnica de PCR, podendo detectar a contaminação de forma precoce e tomar ações corretivas a tempo.

Implementation of toxicologic pathology peer review based on the new edition of China Good Laboratory Practice / 国际药学研究杂志

The Chinese Food and Drug Administration issued the new Good Laboratory Practice(GLP)for nonclinical safety studies in September 2017,which emphasizes the peer review during the pathology practice.Pathology peer review could verify and im?prove the accuracy and quality of pathology diagnoses and interpretations in discussion.Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies.The objectives of this review are to provide a unified interpretation of the new regulation and recommend compliant processes for organizations to implement.

Main technical points of quarantine inspection of Beagle dogs used for drug GLP experiment / 中国比较医学杂志

The quarantine inspection and acceptance of laboratory animals is an important work, which can protect animals from pollution, occurrence and spread of diseases in the surounding area, and it is the key point to realize the quality standardization of laboratory animals.Beagle dogs are acknowledged widely as specialized laboratory dogs which is widely employed in experiments of drug safety evaluation because of the good genetic stability, environmental adaptability, disease resistance and consistency testing in the experiments.Establishment of standard operating procedures of beagle dog quarantine acceptance check for drug GLP organization tests, refining technical points, strengthen the technical training of quarantine officers, and efforts to improve the level of quarantine are needed to finally ensure the quality of laboratory animals.

3Q verification of automatic blood coagulation analyzer under good laboratory practice system / 国际检验医学杂志

Objective To explore the procedures of 3Q validation for blood coagulation analyzer under the good laboratory prac‐tice(GLP) system based on the Sysmex CA7000 automatic blood coagulation analyzer .Methods Four test indicators of PT ,APTT , TT and FIB were chosen to conduct the performance verification in the within‐run precision ,between‐day precision ,accuracy ,linear‐ity ,carry‐over contamination rate of the automatic blood coagulation analyzer .They were prothrombin time(PT) ,activated partial thromboplastin time(APTT) ,thrombin time(TT) ,and fibrinogen(FIB) .Results The within‐run precision CV values of PT , APTT ,TT and FIB were 1 .33% ,1 .57% ,1 .47% and 1 .90% ,respectively ;the inter‐day precision CV values of PT ,APTT ,TT and FIB were 1 .73% ,1 .52% ,1 .55% and 2 .14% respectively ;in terms of accuracy ,the normal quality control CV values were 7 .45% ,3 .88% ,-4 .98% and 4 .36% respectively ;the abnormal quality control CV values of PT and APTT were 8 .11% and 8 .77% respectively ;the r value of FIB linear correlation coefficient was 0 .999 3 ,the a value was 1 .02 ;the highest CV value of car‐ry‐over contamination rate was 2 .15% ;the detected results all conformed to the general industry standards and requirements of in‐strument manufacturer .Conclusion The 3Q validation under the GLP system proves that the Sysmex CA7000 automatic blood co‐agulation analyzer is good in performance and is appropriate for the laboratory work of clinical laboratory department .

In vivo Genotoxicity of Silver Nanoparticles after 90-day Silver Nanoparticle Inhalation Exposure

OBJECTIVES: The antimicrobial activity of silver nanoparticles has resulted in their widespread use in many consumer products. Yet, despite their many advantages, it is also important to determine whether silver nanoparticles may represent a hazard to the environment and human health. METHODS: Thus, to evaluate the genotoxic potential of silver nanoparticles, in vivo genotoxicity testing (OECD 474, in vivo micronuclei test) was conducted after exposing male and female Sprague-Dawley rats to silver nanoparticles by inhalation for 90 days according to OECD test guideline 413 (Subchronic Inhalation Toxicity: 90 Day Study) with a good laboratory practice system. The rats were exposed to silver nanoparticles (18 nm diameter) at concentrations of 0.7 x 10(6) particles/cm3 (low dose), 1.4 x 10(6) particles/cm3 (middle dose), and 2.9 x 10(6) particles/cm3 (high dose) for 6 hr/day in an inhalation chamber for 90 days. The rats were killed 24 hr after the last administration, then the femurs were removed and the bone marrow collected and evaluated for micronucleus induction. RESULTS: There were no statistically significant differences in the micronucleated polychromatic erythrocytes or in the ratio of polychromatic erythrocytes among the total erythrocytes after silver nanoparticle exposure when compared with the control. CONCLUSION: The present results suggest that exposure to silver nanoparticles by inhalation for 90 days does not induce genetic toxicity in male and female rat bone marrow in vivo.

Mechanism and Evaluation Methods of Allergy Caused by Traditional Chinese Medicine Injection / 药物流行病学杂志

Objective:To summarize the allergic mechanism caused by traditional Chinese medicine injection (TCMI) to provide some references for perfecting Good Laboratory Practice(GLP) of TCMI.Method:The related iteratures in data bases at home and abroad were reviewed,and the present experimental research methods about allergies were referred to to have a view of future studies.Result:The allergic mechanism of TCMI was mostly antigen-antibody reaction, part of which was anaphylactoid reaction.The method of the evaluation of allergy caused by TCMI only was animal experiments, but there were still some allergies caused by TCMI after the evaluation with this method.The present experimental research methods indicated that the detection of mediators of inflammation and FCM(Flow Cytometry) could be used to evaluate the allergies caused by TCMI.Conclusion:More attention should be paid to allergies caused by TCMI for its complicated mechanism and frequent occurrences in clinic.It may be an effective way to evaluate the allergies caused by TCMI with several methods including in vivo and in vitro.