scholarly journals Quality assurance strategy of pharmacy compounded drugs

2019 ◽  
pp. 66-72
Author(s):  
O. A. Zdoryk
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management System ◽  
General Scheme ◽  
General Strategy ◽  
Preparation Process ◽  
Critical Factors ◽  
Preparation Conditions

Formulations and in-pharmacy preparation process of compounded drugs were being created for centuries, and seem to have no concerns regarding the quality, compatibility and stability during storage or usage. Taking in mind modern trends for quality assurance and standardization of drugs, quality of preparation process of compounded drugs can be proved by using of a systematic approach that is based on pharmaceutical quality systems. Variability of preparation conditions, preparation equipment from pharmacy to pharmacy, personal professional skills require the development of defined standards, rules and summarized the strategy of quality assurance of compounded drugs. The aim of this paper was determination of critical factors and development of the design for quality assurance of compounded drugs. The materials of this study were the regulative base of Ukraine, international documents, guidances and own investigations concerning the requirements for the preparation process and quality control of compounded drugs. The methods used were data systematical analysis, bibliosemantic and summary. The achievement of good quality of compounded drugs can be present as a step-by-step process, that cover adherence to necessary preparation procedure and knowledge of peculiarities of drugs, process understanding, identification of risks and its evaluation, minimization and implementation of the quality management system for documentation, equipment and personnel. As a result of preparation schemes analysis, the critical factors were determined and the Fishbone diagram was proposed. The factors contributing to the general strategy of compounded drugs quality assurance, such as prescription analysis, personnel, regulative base, conditions of preparation process and equipment, documentation, dispensing, characteristics of active ingredients and additives, compounding design, preparation technology, containers and package, quality control, stability and labelling were determined. The proposed diagram of causes and effects can be used as a template for the identification and quantification of risks during preparation and quality control of compounded drugs. The proposed general scheme for quality assurance is necessary for organization and optimization of monitoring preparation and quality control, implementation of remedial and preventive measures, tracking of causes, nonconformities, and prevention of its repetition, management of variables, determination of improvement possibilities and audit conducting.

A Quality Assurance System in a Pervasive Computing Environment

2010 ◽  
pp. 61-76
Author(s):  
Amitava Mitra
Keyword(s):  
Decision Making ◽  
Quality Assurance ◽  
Quality Management ◽  
Customer Satisfaction ◽  
Management System ◽  
Quality Management System ◽  
Quality Assurance System ◽  
Management Objectives ◽  
Product Service

As the competition for products and services continues to grow, with customer satisfaction playing an integral part in this process, organizations are faced with the task of ensuring quality in all of their activities. Since many organizations do not necessarily produce the entire product or deliver the service by themselves, they are dependent on other vital sources, for example, suppliers, that impact quality of the finished product/service. This necessitates development and implementation of a quality management system which can integrate information from the various entities to facilitate decision making in a timely manner. Additionally, it is desirable for such a quality management system to be responsive to the existing quality environment at the various sources that contribute to the manufacture of the product or delivery of the service. This chapter provides a foundation for accomplishing such quality management objectives.

Quality and Managerial Issues

2013 ◽  
pp. 591-614
Author(s):  
Gavin P Spickett
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management ◽  
Management System ◽  
Regulatory Authority ◽  
Quality Management System ◽  
Clinical Pathology ◽  
Eqa Schemes

Introduction Structure of the NHS and the NHS plan Clinical Pathology Accreditation (CPA) Medicines and Healthcare Products Regulatory Authority (MHRA) Quality management system (QMS) Concepts of quality assurance in the laboratory Quality control (internal) Quality control (external) 1: EQA schemes Quality control (external) 2: benchmarking and CE marking...

scholarly journals Determination of gas-saturated oil density at reservoir conditions and development of quality control index of PVT laboratory report

2020 ◽  
Author(s):  
Muhammad Ali Al-Marhoun
Keyword(s):  
Quality Control ◽  
Production Engineering ◽  
Accuracy Estimate ◽  
Bubble Point ◽  
Laboratory Report ◽  
Reservoir Conditions ◽  
Data Yield ◽  
Oil Density

AbstractThe oil density at the bubble point is an important thermodynamic property required in reservoir simulation and production engineering. A higher-accuracy estimate of this property would improve the accuracy of reservoir and production engineering calculations. The bubble point oil density is obtained either from separator tests of reservoir fluids or from differential gas liberation tests. A new procedure utilizing separator and differential tests is proposed whereby the experimental data yield a unique value with high accuracy for the bubble point oil density. A consistent correction of other PVT properties, which are influenced by the bubble point oil density, is required to reflect the unique density value. A quantitative quality control index is defined to measure the quality of PVT laboratory reports. This is achieved by utilizing the unique property of the bubble point oil density, which is usually ignored.

Analysis of Contractor Pay Adjustment Schedule Using Simulation

1996 ◽  
Vol 1544 (1) ◽  
pp. 109-115
Author(s):  
Robert P. Elliott ◽  
Yanjun Qiu
Keyword(s):  
Computer Simulation ◽  
Quality Control ◽  
Quality Assurance ◽  
Quality Index ◽  
Direct Analysis ◽  
Detailed Examination ◽  
Construction Contracts ◽  
Simulation Process ◽  
Control Quality

A common provision in quality control/quality assurance construction contracts is the adjustment of the contractor's pay on the basis of the quality of the construction. The expected impact of the provision on the pay should be examined to ensure that the adjustments are neither unduly severe nor excessively lenient. Most pay adjustment plans have been developed around a quality index by using a percent defective approach. Analyses of these plans are complex but reasonably well defined. Other plans, however, are more complex and do not lend themselves to direct analysis. These plans can be examined by computer simulation. The use of computer simulation to examine a complex pay adjustment provision is demonstrated. The analyses show that simulation can reveal that a pay adjustment schedule behaves differently than it appears on the surface. For example, the schedule examined bases pay solely on averages and appears to ignore construction variability. The analyses, however, demonstrate that the pay adjustments are at least as sensitive to construction variability as they are to construction averages. It is also shown that the simulation process can provide a better, more detailed examination of the pay schedule than is possible by simply determining the expected pay. In particular, the simulation process can provide an indication of the variability of pay at various quality levels and can identify the factors most responsible for pay adjustments.

scholarly journals Monitoring the quality of sewer renewal using polymeric systems in Sweden

2019 ◽  
Vol 14 (3) ◽  
pp. 605-613 ◽  
Author(s):  
Parastou Kharazmi
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Field Studies ◽  
Infrastructure Investment ◽  
Sufficient Information ◽  
Polymeric Systems ◽  
Water And Wastewater ◽  
Pipe Replacement ◽  
Different Parts

Abstract Water and wastewater pipes require some of the highest levels of infrastructure investment; they also deteriorate faster than they can be repaired. The use of alternative rehabilitation technologies, which are quicker and less expensive than pipe replacement, has therefore increased significantly in recent years, worldwide. Field studies on relined wastewater pipes removed from buildings in different parts of Sweden revealed the existence of a variety of common defects, most of which could have been prevented by better installation. Increased quality-focused monitoring could help to ensure that relined pipes reach their expected service life, while comprehensive documentation could assist in providing sufficient information to facilitate progress in the field. This paper includes a brief overview of the technologies used in Sweden, current quality control practices, repeated observed defects related to installation, crucial steps that affect final quality, and recommendations to be considered in the contexts of detailed quality control and quality assurance procedures.

scholarly journals Employee engagement and improvement as important principles of TQM in public health institutes

2020 ◽  
Vol 8 (1) ◽  
pp. 189-201
Author(s):  
Ana-Marija Vrtodušić Hrgović ◽  
Kristina Črnjar ◽  
Ivana Škarica
Keyword(s):  
Public Health ◽  
Quality Assurance ◽  
Quality Management ◽  
Employee Engagement ◽  
Management System ◽  
Quality Management System ◽  
Customer Focus ◽  
Internal Customer ◽  
The Relationship

Quality assurance in public health presents one of the key factors in the quality of health service. Accordingly, there is increasing awareness of the need to integrate quality systems and their principles into the healthcare system. Their role is important in the context of quality assurance in accordance with patient requirements as well as in the process of improving the quality of health care service. They are essential for the successful implementation of a quality management system and refer to customer focus, leadership, engagement of people, process approach, improvement, evidence–based decision making, and relationship management. This paper presents the results of a study among Croatian Institutes of Public Health with regard to the level of implementation of quality principles related to employee engagement, improvement and internal customer focus. Analysis focused on the relationship between focus on internal customer (employees) and improvements as well as the employee engagement and improvement respectively. Results show there is a strong positive relationship between employee engagement and improvements, while between internal customer focus and improvement the relationship has not been verified. In the context of standardization of quality of public health services, the paper aims to expand theoretical knowledge about TQM principles, with the emphasis on the employee engagement, internal customer focus (employees) and process improvement. The results can serve as a basis for improving the existing practice of quality management system implementation in the public health sector, with emphasis on employees.

Simultaneous quantitation of nine kinds of (d)- and (l)-amino acid enantiomers by HPLC-MS/MS: application to the quality control of amino acid tablets

2015 ◽  
Vol 7 (20) ◽  
pp. 8817-8825 ◽  
Author(s):  
Xiaoyan Li ◽  
Yan Cui ◽  
Yuping Xing ◽  
Chunxiao Lv ◽  
Qing Li ◽  
...  
Keyword(s):  
Quality Control ◽  
Amino Acid ◽  
Simultaneous Determination ◽  
Amino Acid Enantiomers

A HPLC-MS/MS method was developed for the simultaneous determination of nine kinds of (d)- and (l)-amino acid enantiomers and applied to control the quality of amino acid tablets.

scholarly journals Development and Implementation of the Quality Management System as Applied to the Production of Medical Immunobiological Preparations at the Russian Research Anti-Plague Institute Microbe

2012 ◽  
pp. 96-98
Author(s):  
O. A. Lobovikova ◽  
I. V. Shul'gina ◽  
A. K. Nikiforov
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management ◽  
Russian Federation ◽  
Management System ◽  
Quality Management System ◽  
Iso 9001 ◽  
Design And Implementation ◽  
Factors Influencing ◽  
Russian Research

Developed are the methodical approaches for design and implementation of quality management system(QMS) in the production of preventive and diagnostic medical immunobiological preparations manufactured at the Russian Research Anti-Plague Institute Microbe. Analyzed and generalized is the current legislative-normative framework of Russian Federation in the sphere of quality control and quality assurance. Factors influencing the quality management system are revealed. QMS is certified in conformity with the requirements of international standard ISO 9001.

scholarly journals DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ANALYTICAL METHOD FOR DETERMINATION OF AMOXICILLIN IN CAPSULES

2016 ◽  
Vol 13 (26) ◽  
pp. 78-87
Author(s):  
Tiago Hickman IGLIN ◽  
Flávia Nathiely Silveira FACHEL ◽  
Amanda Gonçalves GUWZINSKI ◽  
Airton Monza da SILVEIRA ◽  
Filipe de Medeiros ALBANO ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Forced Degradation ◽  
Semisynthetic Penicillin ◽  
The Stability ◽  
Development And Validation

Amoxicillin, substance-related to semisynthetic penicillin, has been widely used to treat infections caused by various microorganisms, however reports of suitable methods for the quantitative determination and indicative of the stability of formulations containing this substance are rare. Due to lack of studies on the forced degradation of the substance and on the need to monitor the quality of this type of formulation was proposed and validated a method for the determination of amoxicillin content in capsules by high-performance liquid chromatography - HPLC for the quality control of amoxicillin capsules, allowing the provision of useful information about the characteristics of this type of formulation and its stability. The method was validated for parameters of linearity, specificity, accuracy, precision, and robustness

scholarly journals DETERMINATION OF THE POLISHING QUALITY IN THE WORKING CHANNEL OF THE DRAWING OF CARBIDE TOOLS PRODUCED BY OJSC «BSW – MANAGEMENT COMPANY OF HOLDING «BMC»

2018 ◽  
pp. 75-81
Author(s):  
T. P. Kurenkova ◽  
I. V. Borisovets ◽  
I. P. Lazebnikova
Keyword(s):  
Quality Control ◽  
Roughness Parameter ◽  
Sufficient Accuracy ◽  
Central Laboratory ◽  
Drawing Tool ◽  
Destructive Testing ◽  
Visual Method ◽  
Management Company

The quality of the drawing tool depends on the quality of the channel. Channel processing is carried out in order to obtain the desired geometric shape, required size and limit deviations in accordance with the size and quality of the wire stretched, as well as to obtain the required purity of the surface of the channel drawing. The determination of the surface roughness in the die channel is not possible due to the design of the die, so the quality control of the channel polishing is carried out by a visual method using a stereoscopic microscope.In the laboratories at the Central laboratory of OJSC «BSW – Management Company of Holding «BMC» the experience was undertaken for the determination of the roughness parameter in the channel of the dies by the method of destructive testing. The results obtained show that the visual method of quality control of the working channel polishing of the carbide drawing tool with the help of a stereoscopic microscope provides sufficient accuracy of assessing the quality of the roughness of the surface of the working channel when monitoring the draw die intended for coarse-medium and thin drawing.

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