scholarly journals Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

2017 ◽  
Vol 2 (1) ◽  
Author(s):  
Frederic Lagarce

AbstractTo assess the quality of centrally prepared cytotoxics a global approach is being implemented by pharmacists. A risk analysis is performed, and then many in-process controls are proposed. The aseptic process and the material are also fully validated. Moreover the skills of pharmacy technicians are being checked and monitored over time. This short opinion paper discusses the place of in-process quality control within the quality system applied to cytotoxic preparations. It also discusses the pros and cons of analytical control of the final product versus continuous control of each preparation step by eye witness or an electronic device such as a camcorder. Finally the relevancy of controls is discussed in function of different cases and of the human and material resources available in the pharmaceutical technology cytotoxic unit.

1994 ◽  
Vol 77 (3) ◽  
pp. 785-789
Author(s):  
Miguel Valcárcel ◽  
Angel Ríos

Abstract After a brief introduction to the generic aspects of automation in analytical laboratories, the different approaches to quality in analytical chemistry are presented and discussed to establish the following different facets emerging from the combination of quality and automation: automated analytical control of quality of products and systems; quality control of automated chemical analysis; and improvement of capital (accuracy and representativeness), basic (sensitivity, precision, and selectivity), and complementary (rapidity, cost, and personnel factors) analytical features. Several examples are presented to demonstrate the importance of this marriage of convenience in present and future analytical chemistry.


1982 ◽  
Vol 65 (6) ◽  
pp. 1509-1513
Author(s):  
Robert C Gelardi

Abstract Throughout the months following the discovery of the low-chloride problem in infant formula, the industry undertook independent and voluntary measures to ensure the compositional quality of formulas. Members of the Infant Formula Council reviewed industry procedures, practices, and policies, and submitted a detailed description of its quality control and clinical testing procedures to the Food and Drug Administration. New product concepts and product reformulation proposals are based on medical and nutritional findings, on changes in medical concepts for nutritional support, on availability of improved nutrient sources, or on improved ingredients or processing technologies. Quality control is maintained throughout the manufacturing process through inspection of raw materials, analysis of major and minor constituents, equipment and process controls, and continuous product monitoring. However, despite cooperation of the infant formula industry with FDA and Congress during the development of the infant formula bills, the proposed document was too rigid and did not take into account that manufacturing methods of a given manufacturer often vary for the same product, for different products, and on different production equipment. The statistical criteria established uneven and inconsistent requirements for various manufacturers. Congress did not forsee that the proposed regulatory procedures would significantly affect industry.


Author(s):  
W.-S. Liu

Technology has provided us work convenience and shaped our quality of life; it has enabled an unprecedented level of access to knowledge by flipping screen of a hand-held electronic device without going elsewhere but stay connected wireless communication. This kind of technology has been broadly acquired at museums in Hong Kong for preserving their valuable collections. Similar gadget was applied on the monitoring system to record climatic conditions of museum’s stores and galleries. Sensors have been equipped with chips for the wireless transmission of RH/Temp, without installation of any conduit or LAN lines. Useful and important data will then be grouped into a packet format for efficient delivery. As long as the static IP address of the target workstation has been set, data can be accurately retrieved from one place to another via commercially available browsers, such as: Firefox or Internet Explorer, even on hand-held electronic devices. This paper will discuss the detail of this system, its pros and cons in comparison with the old model. After all, the new technology is highly significant in supporting the current needs and the future developments of the museum service.


Author(s):  
Russell L. Steere ◽  
Eric F. Erbe ◽  
J. Michael Moseley

We have designed and built an electronic device which compares the resistance of a defined area of vacuum evaporated material with a variable resistor. When the two resistances are matched, the device automatically disconnects the primary side of the substrate transformer and stops further evaporation.This approach to controlled evaporation in conjunction with the modified guns and evaporation source permits reliably reproducible multiple Pt shadow films from a single Pt wrapped carbon point source. The reproducibility from consecutive C point sources is also reliable. Furthermore, the device we have developed permits us to select a predetermined resistance so that low contrast high-resolution shadows, heavy high contrast shadows, or any grade in between can be selected at will. The reproducibility and quality of results are demonstrated in Figures 1-4 which represent evaporations at various settings of the variable resistor.


2019 ◽  
Vol 2 (5) ◽  
Author(s):  
Tong Wang

The compaction quality of the subgrade is directly related to the service life of the road. Effective control of the subgrade construction process is the key to ensuring the compaction quality of the subgrade. Therefore, real-time, comprehensive, rapid and accurate prediction of construction compaction quality through informatization detection method is an important guarantee for speeding up construction progress and ensuring subgrade compaction quality. Based on the function of the system, this paper puts forward the principle of system development and the development mode used in system development, and displays the development system in real-time to achieve the whole process control of subgrade construction quality.


In construction production, the safety of constructing buildings and structures is achieved by ensuring the required quality as a result of systematic construction control based on the implementation of a complex of technical, economic and organizational measures at all stages of the object's life cycle. The article deals with the actual problem of improving the quality of construction products-buildings and structures in conjunction with the activities of construction control bodies. The article presents the advanced foreign and domestic experience of ensuring the quality control at the construction sites, providing for the prevention of the underlying causes of defects and increasing the interest of the contractors directly. On the basis of the analysis of the current situation with quality control at the construction market, ways to improve its efficiency by developing a unified system of technological implementation of relevant requirements for the quality of construction products, determining the rational number and business load of construction control engineers, as well as the active activities of self-regulatory organizations in this area are offered.


2020 ◽  
Vol 14 (3) ◽  
pp. 160
Author(s):  
Ildar Gabitov ◽  
Samat Insafuddinov ◽  
Ildar Badretdinov ◽  
Viktor Pavlenko ◽  
Filyus Safin
Keyword(s):  

2007 ◽  
Vol 30 (4) ◽  
pp. 66
Author(s):  
N. Tenn-Lyn ◽  
S. Verma ◽  
R. Zulla

We developed and implemented an annual online survey to administer to residents exiting residency training in order to (1) assess the quality of the residency experience and (2) identify areas of strength and areas requiring improvement. Long-term goals include program planning, policy-making and maintenance of quality control. Survey content was developed from an environmental scan, pre-existing survey instruments, examination of training criteria established by the CFPC and the CanMEDS criteria established by the RCPSC. The survey included evaluation benchmarks and satisfaction ratings of program director and faculty, preparation for certification and practice, quality of life, quality of education, and work environment. The response rate was 28%. Seventy-five percent of respondents were exiting from Royal College training programs. Results of descriptive statistics determined that the overall educational experience was rated highly, with 98.9% of respondents satisfied or very satisfied with their overall patient care experience. Ninety-six percent of respondents were satisfied or very satisfied with the overall quality of teaching. Preparation for practice was identified as needing improvement, with 26% and 34% of respondents giving an unsatisfactory rating to career guidance and assistance with finding employment, respectively. Although 80% of respondents reported receiving ongoing feedback and 84% discussed their evaluations with their supervisors, only 38% of evaluations were completed by the end of the rotation. The results indicate that residents are generally satisfied with their experiences during residency training, especially with their overall educational experience. Areas of improvement include preparation for practice and timeliness of evaluations. Further iterations of this survey are needed to refine the instrument, identify data trends and maintain quality control in residency training programs. Frank JR (ed.). The CanMEDS competency framework: better standards, better physicians, better care. Ottawa: The Royal College of Physicians and Surgeons of Canada, 2005. Merritt, Hawkins and Associates. Summary Report: 2003 Survey of final-year medical residents. http://www.merritthawkins.com/pdf/MHA2003residentsurv.pdf. Accessed May 1, 2006. Regnier K, Kopelow M, Lane D, Alden A. Accreditation for learning and change: Quality and improvement as the outcome. The Journal of Continuing Education in the Health Professions 2005; 25:174-182.


2019 ◽  
Vol 2019 (5) ◽  
pp. 32-38
Author(s):  
Валентина Косенко ◽  
Valentina Kosenko ◽  
Алла Трапкова ◽  
Alla Trapkova ◽  
Светлана Тарасова ◽  
...  

The article conducts the analysis of system errors detected by Roszdravnadzor by conducting state quality control of circulating medicines, as well as weaknesses in pharmaceutical quality management systems of the manufacturers, that can influence the quality of manufactured drugs.


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