Exploration of the experiment teaching of natural medicinal chemistry for undergraduates / 生物工程学报

Natural medicinal chemistry is one of the important courses for students in pharmacy majors. Its experimental teaching focuses on fostering comprehensive experimental skills and innovative abilities of undergraduates. Liaoning University has explored ways to promote the experimental teaching of natural drug chemistry based on the graduate employment and practical teaching experience in the past decade. These explorations include three aspects, such as synchronizing experimental teaching with theoretical teaching, fostering students' awareness of experimental safety, and improving experimental teaching methods in natural drug chemistry experiments. The practices showed that the reform has achieved a good effect. A teaching system that can achieve the three expected aspects has been established, which improved the teaching effect and quality of natural medicinal chemistry experimental courses for undergraduates. Furthermore, these explorations may facilitate fostering pharmacy specialists who can meet the opportunities of developing Chinese medicine and natural drug research and meet the requirements of employment.

Evaluation andreflection on the good donor practice / 中国输血杂志

Blood donors, as the core of blood collection and supply system, can greatly ensure blood safety and meet clinical demands with effective management. Good donor practice (GDP) is based on the cooperation of multiple departments by multiple methods. In accordance with the principles of science and ethnic, according to the number and frequency of blood donation and blood donation behavior, GDP classified blood donors accurately, and built up a procedure including potential blood donor identification, selection, recruitment, retention and caring to maintain an accurate management system for keeping regular blood donors. The evaluation indicators for the operation of GDP system were set to conduct real-time monitoring and evaluation, so as to achieve efficient and accurate management and ensure the long-term and stable supply of blood resources.

GMP Defects in the field inspection for processed Chinese herbal medicine manufacturers in Anhui Province during 2014 to 2018 / 药学实践杂志

Objective To propose the improvement measures and suggestions for the better quality management of processed Chinese herbal medicine production and provide insights and solutions for the quality control of processed Chinese herbal medicine production. Methods A retrospective statistical analysis was used to analyze the serious defects and major defects found in 50 processed Chinese herbal medicine manufacturers that failed to pass GMP certification in Anhui province from 2014 to 2018. Results The main problems found in processed Chinese herbal medicine manufacturers that failed to pass GMP certification were the low law consciousness of the legal representative or responsibility person, poor performance of key personnel, untraceable original data of the production records or testing, orderless material managements, ineffective operation of the manufacturing management system or quality control system. Conclusion It is recommended that processed Chinese herbal medicine manufacturers should enhance legal awareness, build good faith, pay attention to personnel training and GMP compliance. The regulatory authority should exercise the professionalism to ensure the quality and reliability of processed Chinese herbal medicines.

Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years / 中国医疗器械杂志

OBJECTIVE@#Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement.@*METHODS@#Classify and analyze the on-site audit findings from different type of medical device manufacturers.@*RESULTS@#The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high.@*CONCLUSIONS@#The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.

Comparison Study of Drug GMP Compliance Inspection Information and Its Database between China and America / 中国药房

OBJECTIVE： To provide reference for further improving China’s Good Manufacturing Practice （GMP） compliance inspection information and the construction of related database. METHODS： The relevant information on drug GMP compliance inspections from the websites of drug administration departments in China and America were collected， compared and analyzed from the aspects of the format and content of inspection report， annual report and database construction. The suggestions were put forward for the improvement of China’s drug inspection information and related databases. RESULTS & CONCLUSIONS： There was a large gap in the compliance inspection information and database functions between China NMPA and US FDA. For the drug GMP compliance inspection information， US FDA had established a special database to facilitate the public to use the search information， and had advanced search capabilities. At present， the database in China was not perfect and not a true meaningful database. It can only be browsed in order， and had almost no search function. In the content of drug GMP compliance inspection information， US FDA had made scientific and humanized measures for the description of defects， the advice or assistance provided to enterprises， and the confidentiality of key data， and the publication was timely. The details of the flight/tracking inspection notifications related to drug GMP compliance inspection issued by China CFDI were slightly poorer， and the classification of defects was not clear. The period from the end of the inspection to the release of the notification was longer. It is suggested that China’s drug GMP compliance inspection information and database functions should be improved from expanding the types and scope of GMP inspection information， improving the search function， and providing database instruction manual and refining the report content.

Research on the metrological calibration in the implementation of the new project of pharmaceutical enterprises / 中国医学装备

Objective:To ensure that the metrology calibration in pharmaceutical enterprises is in compliance with the requirements of GMP, the key issues in the metrology calibration that is in the process of the implementation of the new project of pharmaceutical enterprises are researched on. Methods: The six key issues in the metrology calibration process are identified and are researched on. The six key issues is collection of the metrology information, completion of metrology information, determination of operating range and maximum permissible error, determination of calibration interval, classification management of measuring equipment, formulation of internal calibration procedure, and practical methods for the above issues are presented.Results: the metrology calibration process is controllable, the measurement result is accurate and reliable, and the measurement data can be traced back. Conclusion:when the implementation of pharmaceutical enterprises new projects, that the key issues of the metrology calibration process are made good use of these solutions can lay a good foundation for future work, and ensure that the metrology calibration process is in compliance with the requirements of GMP.

(GOOD MANUFACTURING PRACTICE) / Монголын эм зүй, эм судлал

Эмийн бүтээгдэхүүний зах зээлийн зөвшөөрөл (лиценз) нь үндэсний эрх бүхий байгууллагаар үйл ажиллагаа нь тогтмол хянагддаг эм үйлдвэрлэгчийн лицензтэй эмийн үйлдвэрт үйлдвэрлэгдсэн бүтээгдэхүүн олгогдох ёстой. GMP гарын авлага нь стандартын статустай, ДЭМБ-ын олон улсын худалдаан дах эмийн бүтээгдэхүүний чанарын Сертификатын схемийн нэг бүрэлдэхүүн хэсэг бөгөөд эрх бүхий шалгалтын үндсэн баримт бичиг юм. Түүнчлэн эмийн байцаагчид болон үйлдвэрийн чанарын хяналт, чанарын баталгаажилт, үйлдвэрлэлийн хүний нөөцөд зориулсан сургалтын материал болдог.

Diversity, Utility, Analytical Methods and Use Implications of Aroma-active Compounds from Select Angiosperm Familie.

Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods.

Good manufacturing practice in brazilian wheat mills with particular reference to the flour fortification

Iron deficiency anemia (IDA) is a widespread nutritional disorder that affects a significant proportion of the Brazilian population. The obligatory fortification of wheat flour with iron and folic acid represents a strategy of the Brazilian Ministry of Health for combating IDA. However, several studies have reported the occurrence of iron in excessive concentrations and insufficient contents of folic acid in commercial flour samples. In the light of these information, a participatory observational study on the wheat flour production processes was undertaken in 11 major flour mills located in the São Paulo state, Brazil. This study aimed at writing a detailed good manufacturing practice (GMP) guidelines for the industrial sectors, including directives for standardized operational procedures (SOPs) on the flour fortification. The outcomes of this study are a GMP checklist and the recommended SOPs, which help to standardize the production processes in flour fortification, which currently is incongruous one, and also to facilitate the work of the government health inspectors...

Results of the assessment study of GMP implementation level among local pharmaceutical manufacturers / Монголын Анагаах Ухаан

IntroductionCurrently there are 31 pharmaceutical manufacturers in Mongolia. The first standard on Goodmanufacturing practice was adopted in 2005 and during these 9 years the Good manufacturing practicestandard was upgraded twice in 2011 and 2014, and the latest version reached to WHO GMP guidelinelevel.Purpose of the studyAccording to the Law of Medicine and medical devices of Mongolia, all pharmaceutical manufacturersshould comply with the Good manufacturing practice standard MNS 5524:2014. The study was aimedto asses GMP implementation level among local pharmaceutical manufacturers and to define mostlyobserved deficiencies in three categories as “critical”, “major” and “minor”.Materials and MethodAll stable operating pharmaceutical manufacturers were asked to be involved in this study accordingto the Helsinki declaration and 11 of them were involved. Direct observation method was used for thisstudy. WHO guideline on Good manufacturing practice: Main principles and on Sterile products wasused as the criteria of the assessment.ResultsAll deficiencies observed during the study were classified into three groups as critical, major and minorand the frequency was defined.Conclusions:The critical deficiencies are related mainly with the design and general layout of the premises and heatingventilation and air conditioning system. It requires investment and proper planning from the manufacturers.The major deficiencies are mainly related to documentation, qualification and validation.The minor deficiencies are with regard of documentation system, technical requirements of equipmentand storage area condition and its management.For taking corrective actions of major and minor deficiencies do not require investment, but it requirestime, training, implementation, monitoring and continuous improvement from the manufacturer.

Estudio descriptivo de las prácticas de manufactura en la industria panelera de los trapiches San Francisco y La Esmeralda en Boyacá y Caldas / Descriptive study of manufacturing practices of panela (Brown sugar) industry from the San Francisco and La Esmeralda mills (Boyacá and Caldas, Colombia)

El objetivo de este proyecto fue evaluar la aplicación de las prácticas de manufactura en los trapiches San Francisco y La Esmeralda mediante la aplicación de encuestas etnográficas, documentación fotográfica e identificación de contaminantes microbiológicos presentes en la panela, manos de empleados e implementos de trabajo. En los resultados obtenidos se encontró que una proporción importante de las muestras presentaron contaminación por bacterias como Staphylococcus epidermidis, Streptococcus uberis, Leuconostoc mesenteroides, Bacillus spp, Corynebacterium spp, Actynomices spp, Lactococcus lactis y Gardnerella vaginalis, y hongos como Fusarium spp, Aspergillus spp, Paecilomyces spp, Penicillium spp y Mucor spp, demostrando falencias en el proceso de producción por la falta de implementación de las Buenas Prácticas de Manufactura. A partir del estudio, se recomendó capacitar a los empleados periódicamente acerca de la manipulación de alimentos y prácticas básicas de higiene y realizar una vigilancia más estricta a los trapiches.

In this study was evaluated the implementation of manufacturing practices in the San Francisco and La Esmeralda mills through ethnographic surveys, photographic evidence and recovery of microbiological contaminants from panela, employees hands and working tools. A significant proportion of samples from hands, work tools and panela were found contaminate with bacteria such as Staphylococcus epidermidis, Streptococcus uberis, Leuconostoc mesenteroides, Bacillus, Corynebacterium, Actinomyces spp, Lactococcus lactis and Gardnerella vaginalis, and fungi including Fusarium spp, Aspergillus spp, Paecilomyces spp, Penicillium spp and Mucor spp. These results revealed failures in the production process due to the lack of implementation of Good Manufacturing Practices. Based in this study it was recommended to give regular trainings to the employees about food handling and basic hygiene practices. Also carry out a strict monitoring of the mills in order to be able in the future to rank Colombia as greater panela producer and exporter.

Problems associated with clinical trials of Ayurvedic medicines / Problemas associados com ensaios clínicos de medicamentos Ayurvédicos

Herbal drugs have been used since ancient times as medicines for the treatment of various diseases. Especially in countries like India many of herbal drugs and formulations are used in different practices of treatment like Ayurveda, Siddha and Unani. It is estimated that about 25 percent of all modern medicines are directly or indirectly derived from plants sources. The contribution of developing countries in global herbal business is very poor due to lack of quality control and standardization measures. There is lack of common standards and appropriate methods for evaluating Traditional Medicine to ensure the safety, efficacy and quality control. This indicates the importance and necessity to develop a standard operational procedure for the standardization of herbal drugs and formulations. Benchmarking the evaluation protocols including both quality control and quality assurance of herbal drugs would play a major role in providing highly reliable and effective herbals drugs and to attract international trade, thus generating revenue. The article highlights various problems being faced by developing countries and suggests a unique approach for the preparation of SOP/guidelines for the standardization of all herbal based formulations, also there is a need for systematic clinical trials of traditional plant based medicines to enhance global acceptance

Provável surto de toxinfecção alimentar em funcionários de uma empresa no litoral da região sudeste do Brasil / Presumptive outbreak of food-borne disease among employees working for a company in the southeastern coastal region of Brazil

Foi descrito um provável surto de toxinfecção alimentar em 10 funcionários de uma empresa do município do Guarujá, Estado de São Paulo, em setembro de 2009. A empresa produtora das refeições encaminhou ao Setor de Microbiologia Alimentar do Instituto Adolfo Lutz (IAL) - Laboratório Regional de Santos as amostras dos alimentos, suco e água servidas no almoço dos empregados de uma empresa cliente. As amostras foram analisadas seguindo-se a metodologia descrita no Compendium of Methods for the Microbiological Examination of Foods (2001) e Standard Methods (2005); os resultados foram comparados de acordo com os padrões microbiológicos estabelecidos pela Resolução RDC nº 12/2001 da ANVISA e pela Portaria nº518/2004 do Ministério da Saúde. Os coliformes totais foram detectados na amostra de água e os coliformes termotolerantes foram identificados na amostra de salada de alface com queijo servida no restaurante(N.M.P. 1,1x103/g). Não foram isolados Staphylococcus coagulase positiva, Bacillus cereus, Salmonellaspp. e tampouco clostrídios sulfito-redutores. Os resultados das análises microbiológicas associados aos sintomas de gastroenterites em funcionários sugerem a ocorrência de surto de toxinfecção alimentar. O presente relato mostra a importância do trabalho do Laboratório de Saúde Pública na elucidação de doenças transmitidas por alimentos.

Foi descrito um provável surto de toxinfecção alimentar em 10 funcionários de uma empresa do município do Guarujá, Estado de São Paulo, em setembro de 2009. A empresa produtora das refeições encaminhou ao Setor de Microbiologia Alimentar do Instituto Adolfo Lutz (IAL) - Laboratório Regional de Santos as amostras dos alimentos, suco e água servidas no almoço dos empregados de uma empresa cliente. As amostras foram analisadas seguindo-se a metodologia descrita no Compendium of Methods for the Microbiological Examination of Foods (2001) e Standard Methods (2005); os resultados foram comparados de acordo com os padrões microbiológicos estabelecidos pela Resolução RDC nº 12/2001 da ANVISA e pela Portaria nº 518/2004 do Ministério da Saúde. Os coliformes totais foram detectados na amostra de água e os coliformes termotolerantes foram identificados na amostra de salada de alface com queijo servida no restaurante (N.M.P. 1,1x103/g). Não foram isolados Staphylococcus coagulase positiva, Bacillus cereus, Salmonella spp. e tampouco clostrídios sulfito-redutores. Os resultados das análises microbiológicas associados aossintomas de gastroenterites em funcionários sugerem a ocorrência de surto de toxinfecção alimentar. Opresente relato mostra a importância do trabalho do Laboratório de Saúde Pública na elucidação de doençastransmitidas por alimentos.

Qualidade sanitária de alimentos artesanais produzidos na Região do Alto Jequitinhonha / Sanitary quality of artisanal foods produced in the region of Alto Jequitinhonha

Com o objetivo avaliar a qualidade sanitária de alimentos artesanais produzidos na região do Alto Jequitinhonha, Minas Gerais, foram realizadas análises microbiológicas em 49 amostras de alimentos artesanais e analisadas conforme recomendações da legislação vigente. A contagem de bolores e leveduras variou de 1 x 10 a 4,5 x 10³ UFC/g nas amostras de doces e de 1 x 10³ a 5 x 10³ UFC/g nas amostras de rapaduras. Coliformes a 45ºC estavam presentes nas amostras de rapadura com contagem que variou de 1 x 10 a 3 x 10 UFC/g e nas de farinha de mandioca com contagem de 1 x 10 UFC/g. A contagem média de Staphylococcus coagulase positiva em bombons foi de 3,5 x 10² UFC/g e negativa nas demais amostras, assim como a pesquisa de Salmonella sp.. Bacillus cereus apresentou contagem de 10 UFC/g somente na massa da mandioca moída. A contagem média de aeróbios mesófilos foi de 6,0 x 10³ UFC/g nas amostras de caldos de feijão e de mandioca e de 1,0 x 10² UFC/g nas amostras de macarrão massa fresca. Os resultados mostram a necessidade de adoção de praticas adequadas para produção dos alimentos artesanais, visando agregação de valores aos produtos e segurança alimentar para os consumidores.

In order to evaluate the sanitaryquality of the handicraftfood in the areaof Alto Jequitinhonha, Minas Gerais,microbiological analysis were performedin 49 samples of handicraft foodand analyzed to check if they are in accordancewith the recommendations ofthe effective regulation. The mould andyeast counting altematedfrom lx/O to4,5 x J(Y CFUlg in the sweet samplesand in block of raw brown sugar hasaltematedfrom iao to 5x to CFUIg. Coliforms in 45°C were present inblock raw brown sugar, and its countingaltemated from 1 x 10 to 3 x 10CFUlg and in the manioc flour the coliformcounting were about 1x 10 CFUIg. The Staphylococcus coagulase positiveaverage counting in candies wereabout 3,5 x 102CFUlg and negative inthe others samples, as well as in theSalmonella sp. investigation, Bacilluscereus showed a counting of 10 CFUIg only in ground manioc. The mesophilesaerobic average counting wereabout 6,0 x lrY CFUlg in broth beansand manioc samples and about 1,0

Evaluation of the documentation for OPV production in the year of 2006

Background: Good Manufacturing Practice (GMP) is a important part of quality assurance (QA). Implementation of GMP request to establish the documentation system and should be reviewed as well as evaluated strictly. Documentation is important because it helps the competent person make decisions whether to finish the product or not and it is used as a base for inspection. In the year of 2006, 100% OPV production line in Center for research and production of vaccines and biologicals (POLYVAC) had established the document system. Objectives: To evaluate of the documentation for OPV production in the year of 2006 in POLYVAC. Subjects and method: Documentation for OPV production in 2006 were evaluated by standard operating procedure (SOP) (recommended by WHO). The standards included blank space; erase; code and unit of measurement; revision; no signage and others. Results and Conclusion: Documentation is different between departments. Onlymonkey ranch in Reu island applied 100% SOP. 776 errors were found. Among them blank space (32.2%), erase (27%), code and unit of measurement (21%), revision (5%), no signage (12%) and others (3.6%). The results were the basis of promoting implementation of GMP in vaccine manufacturing in POLYVAC.

Brief Discussion on the Problems in Current Good Manufacturing Practice and the Countermeasures / 中国药房

OBJECTIVE:To provide references for the improvement of our country's current Good Manufacturing Practice(GMP).METHODS:In consideration of GMP standards and problems in its implementation,the system,customers,suppliers,business leaders and documentation etc.were analyzed.RESULTS&CONCLUSION:Problems in the GMP standards has influenced the practice of GMP.In order to improve and optimize the GMP standards,it was recommended that process system be integrated to make the design quality in conformity with the manufacturing quality,open quality management system be established,business leader's leading effect be emphasized and clear and universal documentation system be established.

Discussion of GMP Certification in Pharmaceutical Enterprise after 2004 in China / 中国药房

OBJECTIVE:To predict the trend of Good Manufacturing Practice(G MP)certification in China after2004.METHODS:The development and the current situation of GMP certification were summarized,the problems as well as the suggestions were put forward.RESULTS&CONCLUSIONS:GMP certification after2004should be integrated with Inter?national Organization for Standardization(ISO),the domain correlated drug and"Good Agricultural Practices"(GAP),it should be design rational project of GMP certification on the basis of specificity of enterprises in China.