Retrospective validation is a quality assurance tool which uses the historical data, esp. batch production records, of an existing product to provide the evidence that its process is under control. Retrospective validation does not deal with experiments but it requires systematic and comprehensive data analysis. In this work, the granule humidity content and the tablet thickness in the production process of paracetamol tablets including were validated by using Shewhart charts.
Acetaminophen ; Retrospective Studies ; Pharmaceutical Preparations

GMP requires that all procedures should be properly validated...To ensure that processes and procedures remain capable of achieving the intended results, they should routinely undergo critical approvals. To obtain this purpose, the retrospective validation is proceeded with data provided from at least 10 batches. According to a C. Estampe study, we carried out a retrospective validation with Oroken 200mg tablets produced at the Saint Genis-Laval factory of Rh«ne-Poulenc Rorer (French).
Manufactured Materials ; Tablets

Process validation is strictly required in good manufacturing practice. For doing so, Shewhart charts can be used effectively. In this work, two types of Shewhart charts including X-bar chart and R chart were applied to validate the production processes of Rantitidin tablets and Tryotricin lozenges. By using six rules of evaluation, the statistical process control of the mean tablet weights were clearly shown
Pharmaceutical Preparations ; Tablets ; Drug Industry

The objectives of prospective process validation are to evaluate the key variables and their operational ranges and to predict the "worst cases" for each investigated variable. The targets of formulation design and optimization are to establish the quantitative relationships between input variables (ingredients/ processing conditions) and output variables (product properties). There are some intersectional ideas between validation and optimization as input-output relationships, quantifiable and predictable behaviours of input and output variables, constraints of independent and dependent variables, etc. The formulation design and optimization for paracetamol tablets, in combination with process prospective validation, using the optimization and what if prediction performed by INForm v3.0 as a frame work, was successfully done to (a) determine the critical variables as well as to estimate their optimized values, (b) to investigate the variable limits as well as to predict some worst cases
Pharmaceutical Preparations ; Formularies ; Drug Industry

Background: The combination medical between army and pepople in protection, healthcare for people and army in the whole country was a great policy of The Party and State. Objectives: Evaluate result of combination between armed forces in epidemic control and preventive medicine programs at mountainous and coastal areas of Thua Thien Hue in 2006. Studying knowledge, attitude, practice of army medical officers and men canvassed masses about epidemic control and preventive medicine programs. Subjects and method: Officers, men, army medical officers in 41 communes (28 coastal communes and 13 mountainous communes) of 5 district have combination medical between army and pepople. Using epidemiology method to description, analysis, cross-sectional study. Results: In 2006, home-flies spraying was carried out in 18 out of 20 markets; 1,030 all size restaurants and 18 residential areas of 5 districts. The number of chemically treated latrines in high epidemic areas was accounted fof 15,1%. A population-based latrine construction project was initiated to build 838 new latrines, contributing to minimize the invironmental pollution. 9,17% of waterwells and water tanks were hygienically treated; 11,434 people used clean water source; and 46,436 people washed their hands with soap. Studying knowledge, attitude, practice on preventive medicine programs of army medical officers showed very good results. Conclusion: The combination medical between army and pepople in preventive medicine, epidemic control gave wide efficiency for mountainous and coastal communes of Thua Thien Hue. It actively supported for Health station of 28 coastal communes and 13 mountainous communes in preventive medicine work.
Community Health Services/ ethics ; manpower ; Health Knowledge ; Attitudes ; Practice ;

Background: At present, management and supervision on food safety and hygiene quality have many difficulties because supervisory system from province to district, commune is still insufficient. Objectives: Assessment on food safety and hygiene situation at Thua Thien Hue province, propose solutions to intensify State management on food safety and hygiene quality and step by step enhance efficiency of food safety and hygiene activities in the next years. Subjects and method: Food processing establishments at Thua Thien Hue province. Method: Inspection in Action months for food safety and hygiene, supervision usually on food processing establishments were chosen accidentally in area. Food samples were inspected indexes of microorganisms, physicochemical have met the criteria of Ministry of Health. Results: The proportion of food processing establishments and cafeterias which have not met the regulations on food safety and hygiene was decreasing from 40,93% to 27,45%. Also in 2002-2006, 36,71% of kitchen utensils and the cooks\ufffd?hands failed to meet the regulations. Regarding to microorganisms, the indices of ice-cream, bean sweet porridge and soft drinks had improved remarkably. The index of ice had been decreased from 33,02% to 22,56%. 45,25% of bowls and plates didn\u2019t meet chemical and physical criteria. 68,4% of food colourings didn\u2019t meet criteria because inorganic and industrial colourings were used. Traditional foods still contain borax although the prevalence is decreasing from 65% to 35%. Ice cream and bean sweet porridge cooked with saccharine were 37,34%. Conclusion: Understanding of producers and consumers about food have still many limitations.
Food Safety/ methods ;

Background: HIV/AIDS pandemic really become danger to mankind on the earth. Objectives: Description epidemiological characteristics of HIV/AIDS patients. Studying clinical expression, learning aboutdemands of infected patients and community care for infected patients. Subjects and method: 71 HIV/AIDS people in Thua Thien Hue were studied in 2006. Using descriptive method to give epidemiological characteristics and behaviour of HIV/AIDS people. People were determined HIV/AIDS infection based on the criteria of Ministry of Health. The information were collected by target study. Results: HIV/AIDS people mainly from the age of 20 to 39 (83,10%), males were 52,10% and in various levels of education and all kinds of occupation. The rate of sexually transmitted infection was 84,5% and infection transmission was 15,5%. The rate of sexually transmitted infection within the last 12 months was 57,7%. 63,4% of infected people used condom while having sex with their spouses or partners. 1,4% of infected people using drug infection within the last month. 38% of the infected people had manifestations of AIDS, 77,8% of HIV/AIDS were treated with antiviral drugs. Families and communities had positive attitudes and behaviors to the HIV/AIDS people. Infected people being remoted from the society was 12,7%, 88,7% of them receiving supports from their communities such as disease treatment, spirit and material supports and job opportunities. Conclusion: Strengthen communication activities to change behavior of HIV/AIDS people and in communitiy to reduce alienation, discrimination for infected people. Execute socialization in care and support for HIV/AIDS people.
HIV/ immunology ; isolation & ; purification ; pathogenicity ; Community Health Services/ organization & ; administration ; Epidemiologic Methods ;

Salmonella spp. are pathogens involved in most salmonellosis in rabbits. This study examined Salmonella disease in rabbits raised in Thua Thien Hue, Vietnam. Two hundred and 56 rectal swabs of rabbits were taken, and a carrier rate of 33.98% was found. In addition, all the isolated Salmonella spp. strains were 100% motile; positive for H2S, catalase, Voges Proskauer, coagulase, citrate, maltose, and dextrose; and negative for indole, methyl red, urease, oxidase, sucrose, and lactose. The Kirby-Bauer method showed that these Salmonella strains were susceptible to doxycycline (93.2%), tetracycline (84.1%), and levofloxacin (65.9%). On the other hand, they were highly resistant to streptomycin (95.5%), ampicillin (93.2%), colistin (40.9%), and gentamicin (34.1%). Furthermore, polymerase chain reaction used to screen for virulence and specific genes of Salmonella strains showed that all Salmonella strains isolated carried InvA, fimA, and Stn.

The aim of this study is to delineate ‘admixed hybrid’ and ‘introgressive’ Fasciola genotypes present in the Fasciola population in Vietnam. Adult liver flukes collected from ruminants in 18 Provinces were morphologically sorted out by naked eyes for small (S), medium (M) and large (L) body shapes; and human samples (n=14) from patients. Nuclear ribosomal (rDNA) ITS1 and ITS2, and mitochondrial (mtDNA) nad1 markers were used for determination of their genetic status. Total 4,725 worm samples of ruminants were tentatively classified by their size: 6% (n=284) small (S)-, 13% (n=614) medium (M)-, and 81% (n=3,827) large (L)-forms. All the representative (n=120, as 40 each group) and 14 human specimens, possessed maternal mtDNA of only F. gigantica and none of F. hepatica. Paternally, all (100%) of the L-(n=40) and 77.5% (n=31) of the M-flukes had single F. gigantica rDNA indicating ‘pure’ F. gigantica. A majority (90%, n=36) of the S- and 15% (n=6) of the M-worms had single F. hepatica rDNA, indicating their introgressive; the rest (10%, n=4) of the S- and 7.5% (n=3) of the M-flukes had mixture of both F. gigantica and F. hepatica rDNAs, confirming their admixed hybrid genetic status. Fourteen human samples revealed 9 (64%) of pure F. gigantica, 3 (22%) of introgressive and 2 (14%) of admixed hybrid Fasciola spp. By the present study, it was confirmed that the small worms, which are morphologically identical with F. hepatica, are admixed and/or introgressive hybrids of Fasciola spp., and able to be the pathogens of human fascioliasis.
Adult ; DNA, Mitochondrial ; DNA, Ribosomal ; Fasciola hepatica ; Fasciola ; Fascioliasis ; Genotype ; Humans ; Liver ; Ranunculaceae ; Ruminants ; Vietnam

Aims: To isolate and characterize the lactic acid bacteria (LAB) strains from the “mam chua ca ro” (sour fermented fish) in the South of Vietnam and investigate their potential anti-bacterial properties. Methodology and results: Four LAB strains (MCR1, MCR2, MCR3 and MCR4) were isolated from the "mam chua ca ro" product and their anti-bacterial activity was determined using the spot assay and the paper disc diffusion method. The isolated LABs can inhibit Escherichia coli ATCC 25922, Staphyloccocus aureus ATCC 25923 and Vibrio parahaemolyticus BV016 and produce bacteriocin to control the growth of E. coli ATCC 25922 and S. aureus ATCC 25923, except V. parahaemolyticus. MCR2 was chosen to sequence 16S rRNA of Pediococcus acidilactic. Conclusion, significance and impact of study On the basis of their prominent anti-pathogenic bacteria activity, LAB strains isolated from Vietnamese sour-fermented fish products were verified as prospective probiotics.
Lactobacillales--isolation & ; purification ; Pediococcus acidilactici