Quality System Requirements Research Articles

Quality System Requirements of Dietary Supplements: An Overview of 21 CFR Part 111

Quality System Requirements of Dietary Supplements: An Overview of 21 CFR Part 111

ASME Nondestructive Examination (ANDE) Designated Test Organizations (DTOs)

Control of Nondestructive Examination (NDE) and Quality Control (QC) practical examinations are essential for an ANDE Designated Test Organization (DTO). This presentation describes the infrastructure, security, quality system, and practical demonstration requirements as part of the application to be recognized as an ANDE DTO. A key presentation component is the explanation of sourcing, validation, security, and control of the practical demonstration specimens. Acquisition of the practical demonstration specimens, the examination process steps, and applicant administration are key to the ANDE DTO examination designation. Practical demonstration infrastructure includes the physical location, ANDE material and applicant traffic flow, and the sequence of operations for personal practical demonstrations. Learn more about the details of ANDE Certification Body (CB) preparation to meet the rigorous quality system requirements. An ANDE DTO quality system must meet the quality requirements based on ISO 17024 quality system conformance. Other quality system requirements, dependent on regulatory and statutory criteria such as nuclear pressure vessel codes compared to non-nuclear pressure vessel codes can impact the designation of the DTO. This presentation includes an overview of how the tracking of the applicant, specific NDE/QC methods, test categorization, and the test specimens are organized. Reference to the ASME Nondestructive Examination (ANDE) standard will be included as part of this presentation.

A Comprehensive Perspective of Different Compensators of Railway Traction System

Due to their non-linear load characteristics, train locomotives play a significant part in the installation of railway electrification in India and around the world. Numerous techniques have been researched and used with both AC and DC locomotives to enhance power quality. The development of train locomotives is used in this research to provide a viewpoint on various power quality issues as well as to explore the demand for power quality problems and system requirements for acceptable power quality. The many sorts of compensation schemes are contrasted with one another. this would help academics and engineers working on railway electrification.

EASY TO WORK LIBRARY EMPLOYEES IN SMAN 1 KOTA PAGAR ALAM WEB-BASED

This research was conducted at the library of SMAN 1 Pagaralam City because there were problems at the time of borrowing, returning and checking book data and borrower data so that supporting software was needed so that services could be carried out quickly and data processing could be done accurately and could be done anytime where course by the officer or by the borrower of the book, then website-based software is built, this research uses web engineering development and methodology, and so that in the implementation of website development a quality software application model or system requirements specification is used, in the following order: formulation, analysis, planning, engineering, page generation, and evaluation. So that this research has produced software that can be used by library staff of SMAN 1 Pagaralam City when serving book borrowers and processing book data, so the performance of library staff is getting better.

Audit requirements and expectations, The good and better about MDSAP Regulations

The most sure-fire way to pass MDSAP audit with flying colours is to have an effective Quality Management System (QMS). Having a good QMS will make sure work is correctly documented, kept up to date, and easy to present to an auditor. For regulators too, it means a reduced burden. There is pooling of regulatory resources. The audits are conducted by Auditing Organizations designated by the regulatory bodies. The MDSAP program is expected to improve audit predictability because a standardized audit model has been introduced. Every audit follows the same set of steps. For the first time, a grading system is introduced for noncompliance. This approach helps reduce subjectivity. MDSAP has a very rigid auditing process to ensure the proper market authorizations have been obtained and facility registrations have occurred but not represent Marketing Authorization. Recently proposed greater alignment of FDA Quality System Regulation (QSR) with ISO 13485, would bring US QMS requirements for medical device manufacturers closer in line with quality system requirements in markets such as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.

Reporting uncertainty for gas certified reference materials: balancing customer requirements with calibration and measurement capabilities

The effect of rounding when presenting the uncertainties associated with bespoke gas certified reference materials has been investigated. This has been examined in the context of wanting to provide the customer with as close a match as possible to what was originally contracted whilst needing to comply with the minimum uncertainties allowed by internationally agreed calibration and measurement capabilities under the International Committee for Weights and Measures’ Mutual Recognition Arrangement or other scopes of accreditation. The effect of rounding has, in relative terms, been shown to be large in some cases and this has prompted an investigation into improved methods to express more precisely values presented on certificates accompanying bespoke gas certified reference materials. This has included a new proposal to present relative, instead of absolute, uncertainties on certificates thereby matching exactly customer requirements. This Practitioner’s Report also demonstrates how considerations of customer and quality system requirements should be properly balanced and how internal review of technical procedures leads to continuous improvement.

Application of principles of supply chain management to the pharmaceutical good transportation practices

PurposePharmaceuticals supply chain management (SCM) requires special expertise to transport the medicinal products because of weird features of their demand, supply and sensitivity towards quality. The purpose of this study is to establish the linkage of pharmaceutical quality system requirements with the SCM principles. The study enables the collaborative approach of technical, transport, logistics and supply chain teams within the pharmaceutical industry.Design/methodology/approachThe methodology followed for this study is literature review and survey. The study is supplemented with data obtained through the structured questionnaire.FindingsThrough this study, an exclusive perspective for pharmaceutical good transportation practice (GTP) has been propagated in alignment with seven principles of SCM by Anderson. This study offers guidance to pharmaceutical industry for transportation of products by conceptualizing basic supply chain features such as segmentation, customization of requirement, market signals, differentiation, technology orientation and channel spanning performance.Research limitations/implicationsHere is limited information available about the transportation failures in the pharmaceutical industry. Application of supply chain principles to pharmaceutical transportation is sometimes affected by technical knowledge bias of the researcher.Practical implicationsThe study has successfully expounded the practical aspects of pharmaceutical GTP for supply chain professionals.Social implicationsThe study facilitates the patients and pharmaceutical consumers to get quality products in a timely manner across the globe.Originality/valueThe application of SCM principles to the pharmaceutical GTP is the result of novel research and has not been studied earlier.

A retrospective study on annual evaluation of radiation processing for frozen bone allografts complying to quality system requirements.

Bone allografts have been used widely to fill up essential void in orthopaedic surgeries. The benefit of using allografts to replace and reconstruct musculoskeletal injuries, fractures or disease has obtained overwhelming acceptance from orthopaedic surgeons worldwide. However, bacterial infection and disease transmission through bone allograft transplantation have always been a significant issue. Sterilization by radiation is an effective method to eliminate unwanted microorganisms thus assist in preventing life threatening allograft associated infections. Femoral heads procured from living donors and long bones (femur and tibia) procured from cadaveric donors were sterilized at 25kGy in compliance with international standard ISO 11137. According to quality requirements, all records of bone banking were evaluated annually. This retrospective study was carried out on annual evaluation of radiation records from 1998 until 2012. The minimum doses absorbed by the bones were ranging from 25.3 to 38.2kGy while the absorbed maximum doses were from 25.4 to 42.3kGy. All the bones supplied by our UMMC Bone Bank were sterile at the required minimum dose of 25kGy. Our analysis on dose variation showed that the dose uniformity ratios in 37 irradiated boxes of 31 radiation batches were in the range of 1.003-1.251, which indicated the doses were well distributed.

Personnel certification as products quality improvement factor

The necessity of introducing personnel certification at agricultural enterprises is substantiated. The hierarchy of measures, encouraging labor productivity, at agricultural enterprises, which directly affect the reproduction processes of the industry and their financial situation improvement in conditions of economic instability, is proposed. Currently, any production system requires introducing new information technologies, highly sophisticated machinery and equipment, developing communication linkage that will significantly increase the standards of living and satisfying the needs of society. The purpose of the study is to solve the issues on reproducing the agricultural sector through introducing personnel certification.It can be concluded from the aforesaid that all the complex and various tasks, which need to be solved at agricultural enterprises, require specific expertise and skills from their personnel, so personnel is one of the main enterprise quality resources. Appropriate level of expertise and skills is achieved primarily through training. High-quality training of personnel is its willingness to perform all the key functions of the company according to the quality system requirements. Consequently, it is based on the principles of universality, commitment, continuity and hierarchical order.

Food Safety Test Information System Design

Informatization of food safety supervision overviews in China and some other countries were studied. With the combination of food safety supervision characteristics in Guizhou and quality system requirements for national food inspection laboratory, information management system for food safety in Guizhou was proposed. A knowledge database for categorizing determination factors of food hazard was established. This system was implemented in the food safety supervision of circulation links in Guizhou for 3 years (2009-2011). It solved problems such as quality control for massive sampling inspections and data analysis. Besides improving work efficiency, it provided scientific basis for decision making of food safety supervision to government as well as data support for food safety forecasting and warning system.

How ISO-15189 laboratory accreditation assures patient safety? / Kako ISO-15189 akreditacija laboratorija osigurava bezbednost pacijenta?

Summary Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occurrence of medical errors. Patient safety is one of the most serious global health issues and defined as the absence of preventable harm to a patient during any process of medical care. The frequency of medical errors is higher than expected. It has been concluded that the majority of medical errors are not because of the individual attitudes but mainly caused by faulty systems or processes leading the staff to make mistakes or fail to prevent them. Patient safety is a shared responsibility comprised of many stakeholders such as society, patients, nurses, educators, administrators, researchers, physicians, government and legislative bodies, professional associations and accrediting agencies. Medical laboratory services are essential to patient care and need to be available to meet the needs of both patients and caregivers. ISO- 15189:2007 Medical Laboratories-Particular requirements for quality and competence, an internationally recognized standard containing requirements necessary for diagnostic laboratories to demonstrate their competence to deliver reliable laboratory services. It applies quality system requirements to the clinical laboratories with a strong focus on responsiveness to the needs of patients and clinicians. Applying the performance improvement strategies focusing on different phases in total testing process will significantly reduce the errors and therefore will improve the patient safety. In this way, laboratory professionals contribute to improvement of safety and outcomes of care by working in interdisciplinary approach manner.

Analytical difficulties facing today's regulatory laboratories: issues in method validation

The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures.

European Quality System for Tissue Banking

The aims of this project were to analyze the factors that influence quality and safety of tissues for transplantation and to develop the method to ensure standards of quality and safety in relation to tissue banking as demanded by European Directive 2004/23/EC and its technical annexes. It is organized in 4 Working Groups, the objectives of each one being focused in a specific area. The Guide of Recommendations for Tissue Banking is structured into 4 parts: (1) quality systems that apply to tissue banking and general quality system requirements, (2) regulatory framework in Europe, (3) standards available, and (4) recommendations of the fundamental quality and safety keypoints. This Working Group handled design of a multinational musculoskeletal tissue registry prototype. This Working Group handled design and validation of a specialized training model structured into online and face-to-face courses. The model was improved with suggestions from students, and 100% certification was obtained. The Guide for Auditing Tissue Establishments provides guidance for auditors, a self-assessment questionnaire, and an audit report form. The effectiveness and sustainability of the outputs were assessed. Both guides are useful for experienced tissue establishments and auditors and also for professionals that are starting in the field. The registry prototype proves it is possible to exchange tissues between establishments throughout Europe. The training model has been effective in educating staff and means having professionals with excellent expertise. Member states could adapt/adopt it. The guides should be updated periodically and perhaps a European organization should take responsibility for this and even create a body of auditors.

Driving change in manufacturing quality systems by selecting best-fit off-the-shelf software platform

The traditional approach to developing a quality system has been to build it around existing software. Little consideration is given to understanding operational and business requirements of quality systems. Current customers and industry trends, however, suggest an increasing role for effective quality management systems in achieving competitive advantage. This paper presents a systematic top-down approach for the design of requirement-driven quality systems and subsequent selection of the best-fit off-the-self software. The proposed approach captures a company's operational and business goals, and develops a comprehensive list of quality system requirements. These requirements are prioritised and classified based on the Kano model. The best-in-class technical features necessary to fulfill quality system requirements are explored and identified. QFD is used to link company requirements with technical features. Finally, using the Pugh methodology, the best-fit software platform is selected. The proposed methodology has been validated and implemented at a leading global manufacturing company.

658. Development and Evaluation of an Infusion Device for AAV-Mediated Gene Delivery to the Brain

A custom infusion device was developed for delivery of recombinant AAV2 to human putamen in a phase I/II clinical trial for treatment of Parkinson's disease. The device was designed to 1) minimize vector loss to the internal surfaces of the cannula and tubing, 2) minimize the hold-up volume of the device such that vector could be dispensed efficiently from a syringe placed approximately four feet away from the site of infusion, 3) attach to a commonly used stereotactic surgical frame, 4) connect to a programmable syringe pump, and 5) allow manufacturing in compliance with quality system requirements (QSR) for medical devices.

Acoustic emission transducers—development of a facility for traceable out-of-plane displacement calibration

Acoustic emission (AE) is a widely used technique that has been employed for the integrity testing of a range of vessels and structures for many years. The last decade has seen advances in signal processing, such that the reliability of AE technology is now being recognised by a wider range of industries. Furthermore, the need for quality control at the manufacturing stage, and requirements of in-service testing, is encouraging the issue of traceable measurements to be addressed. Currently, no independent calibration service for acoustic emission transducers is available within Europe. The UKs National Physical Laboratory (NPL) is undertaking work to develop a measurement facility for the traceable calibration of AE sensors. Such calibrations can contribute to greater acceptance of AE techniques in general, by meeting quality system and other traceability requirements. In this paper the key issues surrounding the development of such a facility are reviewed, including the need to establish repeatable AE sources, select suitable test blocks and to understand the limitations imposed by AE sensors themselves. To provide an absolute measurement of the displacement on the surface of a test block, laser interferometry is employed. In this way the output voltage of an AE sensor can be directly related to the displacement detected at the block surface. A possible calibration methodology is discussed and preliminary calibration results are presented for a commercially available AE sensor, showing its response to longitudinal wave modes.

Quality control of a detector for the calculations of radiopharmacokinetic parameters of99mTc-glucarate in rats

Good manufacturing practices specify that a well-type scintillation NaI(Tl) crystal detector has to be validated in order to detect radioactivity from any radiopharmaceutical used to obtain radiopharmacokinetic parameters. A 5 cm well-type NaI(Tl) scintillation detector was coupled to a multi-channel analyzer centered at the 140 keV 99mTc peak with a 20% window. The area represents counts per minute (cpm). All the net cpm were decay corrected. The activity source was 99mTc-glucarate developed as an imaging agent for acute myocardial infarction. Wistar rats were injected in a tail vein with 0.1 ml (3.7 MBq) of 99mTc-glucarate solution and 13 blood samples were taken. The cpm were the input data for the WINNONLN program which calculates radiopharmacokinetic parameters. The detector's efficiency for 99mTc was 15.03% and the sensitivity 1.12 kBq/ml in plasma. The response was linear between 0.31-14.3 kBq/ml of 99mTc-glucarate. The maximum assay variation coefficient was 2.79 and recovery of 99mTc-glucarate in plasma was 99.8%±0.2%. LOD was 0.31 kBq and LOQ = 1.12 kBq in plasma samples. 99mTc-glucarate follows a two-compartment model of distribution with Vd of 21.74 ml±2.71 ml; a Vdss of 74.36 ml±12.67 ml; t1/2a0.74 h±0.19 h; t1/2b 18.98 h±4.36 h; AUC = 32.75 mCi/min.ml ± 3.73 mCi/min.ml; MRT = 24.35 h±5.51 h and total clearance 3.05 ml/h±0.35 ml/h. The well-type detector fulfills the quality system requirements and the radiopharmacokinetic parameters for 99mTc-glucarate in rats are reliable.

Blood component fractionation: manual versus automatic procedures

Over the last few years, quality system requirements have been introduced for blood components. The necessary compliance with standard productions will have a considerable impact on Blood Banks. The introduction of automated methods is the most satisfactory means to meet these requirements for blood component preparation. A new device has been developed to automate the fractionation of blood into components. We evaluated the efficacy of this instrument as compared to manual methods. A total of 218 units of blood have been collected, into several different commercial blood bag systems (77 into standard quadruple bag systems, 141 into bag systems with integrated in line filters), and used to evaluate the universality of the instrument. Whole blood units were processed using the Top/Top system and the Compomat G4 (Fresenius HemoCare). A separate program protocol was developed for each kind of bag. Use of the Compomat G4 resulted in a statistically significant ( p<0.001) increase of the hemoglobin in filtered red cell concentrates (RCC) in comparison with the manual procedure, and a similar trend, even not statistically significant, has been observed for filtered RCC. Regardless of bag systems, we were able to observe a statistically significant increase of platelets in the platelet concentrates (PCs), when comparing automatic versus manual procedure. The automated procedure has been shown to be fast, and easy for the operators. This device reliably produces acceptable blood components, and has been shown adaptable to use with different blood bag systems.

Assessing the corporate service quality performance of design-build contractors using quality function deployment

The design-build (D/B) project delivery system has gained increased market share in the last few years. It is superior to traditional systems in some respects but some claim that it does not lend itself to effective quality assurance and control. D/B construction owners who are in the process of selecting a D/B firm for a project should therefore be well informed about the quality performance of potential D/B firms in their bidding list. Total quality consists of the corporate quality culture, the quality of the project service, and the quality of the constructed facility. This paper describes a tool that was developed to measure the corporate service quality of a D/B firm using quality function deployment (QFD). The service quality factors are ranked relative to construction owners' needs and expectations by means of a survey administered to construction owners. The components of quality management systems in place in D/B firms are ranked by D/B executives in a survey administered to senior D/B firms. The relationships between service quality factors and quality system requirements are established by a professional quality system assessor and all these attributes are integrated into one system called the Corporate Service a‘House of Quality.’ The tool developed can be used by construction owners to rank D/B firms relative to corporate service quality as well as by D/B firms to benchmark themselves against their competitors.

Impact of supply chain sensitivity to quality certification on quality management practices and performances

Recent studies on quality management, certification, and supply chain management emphasize that (1) ISO 9000 certification is becoming a must for many companies to compete, and (2) quality is a strategic variable that should be considered and managed not only within the single firm, but also across the supply chain of which the firm is part. Nevertheless, many empirical works on ISO 9000 concentrate on the impact of certification on companies' internal quality systems, whereas they do not pay the same attention to both upstream and downstream interactions across the supply chain, and to their influences on quality management practices and performance. This study examines whether the diffused adoption or knowledge/confidence in the ISO 9000 quality system requirements (i.e. 'sensitivity' to certification) by diverse supply chain members can really influence quality management practices/procedures and operational performance of individual firms in supply chains. These topics are examined through analysis of data gathered by means of a survey based on a sample of 100 Italian certified manufacturing companies. It was found that those firms with the most advanced internal quality systems tend to buy extensively from certified suppliers and to be reliant on the quality level of their deliveries. However, such trust on certified suppliers rarely implies the formalization of medium-long term cooperative programmes. As for performances, the impact of supply chain sensitiveness seems to be significant on punctuality, delivery speed and volume flexibility, while there are no significant effects on quality and cost performance.