iso 17025
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2021 ◽  
Author(s):  
Obi Adigwe ◽  
Judith John ◽  
Christianah Isimi ◽  
Simisola Oloye ◽  
Godspower Onavbavba ◽  
...  

Abstract Background The emergence of corona virus disease caused by SARS-COV-2 (Covid-19) and the subsequent recommendation by the World Health Organization (WHO) on the use of non-pharmaceutical measures led to an upsurge in the production and sale of hand sanitizers across the globe including Nigeria. It is important that product regulation schemes are designed in such a way as to ensure the continual quality of the products to potential clients. Hence, this paper provides an understanding of the quality of alcohol based hand sanitizers in Abuja, Nigeria. Methods A total of fifty (50) different brands of alcohol-based hand sanitizers were purchased from different pharmacies, supermarkets, and stores, within Abuja. In the laboratory, samples were checked for their label claims, NAFDAC registration number, batch number, manufacturing and expiration dates. The information was recorded in the laboratory notebook in accordance with ISO 17025 requirement, then samples were coded as SAN1 to SAN50 and assessed for pH values and Alcohol Content. Results About 40% of the circulating hand sanitizers in the market did not go through regulatory vetting, 34% of the products did not have information on the country of manufacture, 32% of the sanitizers had pH values within acceptable range, while 78% of the products contained less than 60% alcohol. Conclusion This study gives an insight into the quality of alcohol-based hand sanitizers and we suggest an urgent need for the regulatory authorities of developing countries to enhance their surveillance and control of these substandard products in the society.


2021 ◽  
Vol 906 (1) ◽  
pp. 012065
Author(s):  
Ján Ilavský ◽  
Danka Barloková ◽  
Michal Marton

Abstract Many types of pharmaceutical substances have been detected with significant concentrations through various advanced instrumental techniques in surface water, ground water, partially treated water (with concentration typically less than 0,1 ug/L), drinking water (concentration bellow 0,05 ug/L) domestic wastewater, municipal wastewater and industrial effluents (concentration approximately 1 ug/L). Pharmaceutical compounds are found at much lower concentrations in drinking water sources then the normally prescribed doses, but there is concern that chronic exposure to numerous compounds could cause serious health problems and that compounds can act synergistically to cause adverse health effects. The effectiveness of removal the specific pharmaceuticals (paracetamol, carbamazepine, metronidazole and caffeine) from drinking water with adsorption using two types of granular activated carbon (Filtrasorb 400 and WG12) was monitored. Paracetamol is a medication used to treat fever and mild to moderate pain. Paracetamol significantly relieves pain in acute migraine and headache. Carbamazepine is an anticonvulsant medication used primarily in the treatment of epilepsy and neuropathic pain. It is used in schizophrenia along with other medications and as a second-line agent in bipolar disorder. Metronidazole is an antibiotic and antiprotozoal medication. It is used either alone or with other antibiotics to treat inflammatory disease. Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class. It is the world’s most widely consumed psychoactive drug. The concentrations of caffeine in surface waters were detected in the range 0.1 - 6.9 μg/L. The experiments were performed in laboratory conditions with varying values of pH (7,8 or 6,5), stable temperature, and dose of adsorbent. The experiments were performed in the glass bottles with the volume of 400 mL stock model water (drinking water spiked with pharmaceutical standard) with concentration approximately 0.05 μg/L. On the analytical scales weighed out 400 mg GAC was used and then it was added to the bottles. Subsequently these bottles were regularly stirred at 400 rpm. Samples were taken at 30, 60, 120 and 240 minutes, after which they were analyzed. Analyses of target pharmaceutical were performed in laboratories of ALS Czech Republic in Prague. LC-MS methodology (method was validated according to ISO 17025 system) was used to determine pharmaceuticals in water samples. The adsorption efficiency of pharmaceutical removal and the adsorption capacity of granular activated carbon depends on the time of contact of water with the material. Adsorption efficiency for two types of granular activated carbon varies from 13 to more than 90%.


Separations ◽  
2021 ◽  
Vol 8 (10) ◽  
pp. 168
Author(s):  
Xin Chen ◽  
Patrick C. Bailey ◽  
Clarissa Yang ◽  
Bryant Hiraki ◽  
Michael J. Oldham ◽  
...  

Aerosol constituent yields have been reported from a wide range of electronic nicotine delivery systems. No comprehensive study has been published on the aerosol constituents generated from the JUUL system. Targeted analyses of 53 aerosol constituents from the four JUUL products currently on the US market (Virginia Tobacco and Menthol flavored e-liquids in both 5.0% and 3.0% nicotine concentration by weight) was performed using non-intense and intense puffing regimens. All measurements were conducted by an ISO 17025 accredited contract research organization. JUUL product aerosol constituents were compared to published values for the 3R4F research cigarette and IQOS Regular and Menthol heated tobacco products. Across the four JUUL products and two puffing regimes, only 10/53 analytes were quantifiable, including only two carbonyls (known propylene glycol or glycerol degradants). The remaining analytes were primary ingredients, nicotine degradants and water. Average analyte reductions (excluding primary ingredients and water) for all four JUUL system aerosols tested were greater than 98% lower than 3R4F mainstream smoke, and greater than 88% lower than IQOS aerosol. In summary, chemical characterization and evaluation of JUUL product aerosols demonstrates a significant reduction in toxicants when compared to mainstream cigarette smoke from 3R4F reference cigarettes or aerosols from IQOS-heated tobacco products.


2021 ◽  
Author(s):  
Nkereuwem S. Etukudoh ◽  
Uchejeso M. Obeta

Patients’ (clients/customer) services and satisfaction in Medical Laboratory Services and general healthcare is one of the twelve (12) quality essentials of Total Quality Management System (TQMS) emphasized by quality standards as seen in ISO 17025, ISO 15189 and ISO 9001. The patients otherwise referred to as customers or clients to Medical Laboratory and healthcare in general, is the heart-beat and kings to the healthcare system. This chapter looks into the quality aspect of medical laboratory services from the patients’ angle towards thorough satisfaction or dissatisfaction index and otherwise creates room for improvement in the services and healthcare in general. The chapter therefore, identified medical laboratory clients to include patients and patients’ relations, physicians and other healthcare workers, public health and government, communities and interested parties, and medical laboratory profession. There is a need to administer services satisfaction survey developed by Director of Medical Laboratory Services or human resources/quality officers in line with the ISO 15189, ISO 17075 and ISO 9001 to customers/clients from time to time so the outcome can be used to correct services errors and cause quality improvement. It is believed that patients’ satisfaction causes improvement in healthcare, quick recovery of patients and willingness of the patient to return to the healthcare facility in future. Patients’ and customers’ in medical laboratory feedback contributes to quality management and improvement to Medical Laboratory services and healthcare as an ingredient of TQMS.


2021 ◽  
Vol 26 (2) ◽  
Author(s):  
Gouda M. Mohamed ◽  
Riham S. Hegazy

This research article refers to the application of the evaluated measurement uncertainty for deciding the statement of conformity. It is a proposal to rethink about the classification of measuring devices, taking into account the calculations of uncertainty as a decision rule. It is also a base for complete compatibility and harmonization between ISO 17025:2017 and the other standards. To verify this proposal a case study on compression testing machine classification is used. This proposal aims to review classification criteria for these machines. Since the uncertainty value is equivalent to all parameters that may affect the performance of these machines, it is logical and accurate to use it as the basis for the classification. This approach may be employed for the upcoming version of ISO 7500 standard to use the uncertainty value as a base for machine classification.


2021 ◽  
Vol 67 (2) ◽  
pp. 69-75
Author(s):  
Vojislav Božanić ◽  
Vlastimir Dedovic ◽  
Milan Božović

The paper presents an overview of the most important regulations and institutions affecting the level of quality and fittingness of the vehicle fleet, in order to increase the level of general traffic safety in the Republic of Serbia. The Traffic Safety Agency, among other things, alone or in cooperation with others, regulates, controls and implements the system of homologation, testing and control of conformity of vehicles, equipment and parts. It authorizes and supervises other organizations for vehicle control and testing. The role of standardization in this process is dual: first - it refers to the subject of testing - vehicles, and second - to the quality of testing - authorized organizations. The paper discusses the important provisions of regulations for vehicle testing and analyzes the impact of the standards ISO 17020 and ISO 17025 on the work of authorized organizations. In conclusion, it was proposed that in order to achieve and maintain high level of testing quality, mandatory accreditation of authorized organizations should be prescribed. Mandatory application of the standards would have a positive impact on the traffic safety segment which depends on the technical characteristics of the vehicle, and as well, reduce the Agency's obligations.


Author(s):  
Célia Venchiarutti ◽  
Rožle Jakopič ◽  
Carmel Hennessy ◽  
Kalman Toth

AbstractThis paper presents the preparation, characterisation and validation of two quality control (QC) samples for the measurement of plutonium and uranium contents by isotope dilution mass spectrometry (IDMS). These two QC samples were then used at the JRC-Geel G.2′s laboratory to monitor the performance of IDMS measurement results in line with the ISO 17025 and ISO 17034. The QC samples were prepared from two certified reference materials, namely the NBL-126 (Pu) and CRM 116-A (U). The values for the 235U and 239Pu amount contents of the QC samples were assigned based on the gravimetric preparation of the solutions and verified by independent IDMS measurements. Their use as part of a broader in-house spike inter-calibration campaign, notably during participations in proficiency tests, is also highlighted. Finally, using these two IDMS QC samples, a detailed approach to the IDMS uncertainty evaluation, according to the Guide to the expression of uncertainty in measurement (GUM, 2008) is presented on various examples.


2021 ◽  
pp. 1-8
Author(s):  
K.H. McKeever ◽  
H.C. Manso Filho ◽  
E.M. Rankins ◽  
C.S. Duchamp ◽  
Y. Salah ◽  
...  

Clenbuterol, (RS)-1-(4-amino-3,5-dichlorophenyl)-2-(tert-butylamino)ethan-1-ol, as Ventipulmin is an FDA approved β2 agonist medication for the management of airway obstruction in horses. Administration above the FDA approved doses for clenbuterol produces repartitioning effects, which have led to restrictions on its use in human athletics and Quarter Horse and Thoroughbred racing. Clenbuterol, however has long been used therapeutically at FDA approved doses in Harness racing. The goal of this study was to identify a withdrawal time guideline for its use at FDA approvsed dose levels in Harness racing, where horses may start at seven-day intervals. Eight healthy, moderately fit Standardbred horses (4 mares, 4 geldings, weight 491±40 kg, age 13±2 years) were administered 0.8 μg/kg of clenbuterol as Ventipulmin syrup twice daily (BID) for three days. Blood samples were collected prior to dosing and at 1, 24, 48 and 96 h post administration. Clenbuterol was quantified in all samples using the New York Drug Testing and Research Laboratory ISO-17025 Racing and Medication Testing Consortium (RMTC) accredited quantitative procedure. The lower limit of quantitation of the method was 1.0 pg/ml, and three data points at 96 h post administration were censored. One horse developed diarrhoea and data from this horse was excluded from the overall analysis. Plasma regulatory thresholds were calculated using the 95/95 tolerance method and Gauss Camp Meidell at P=0.05 and P=0.001. Horses were also evaluated for effects of clenbuterol on body composition using body mass and ultrasound measurements of rump fat thickness. There were no effects (P>0.05) of clenbuterol on any of the measures including fat mass and fat free mass and thus no repartitioning effect was observed. The pharmacokinetic data and the 96 h data set support the therapeutic use of clenbuterol in Harness horses at the FDA approved 0.8 μg/kg BID dose for three days and suggest a 41 pg/ml regulatory threshold for a 96 h withdrawal time with a P=0.001 probability of randomly exceeding this regulatory threshold.


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