Implementation of a quality assurance system according to GMP and ISO 9001:2008 standard for radiopharmaceutical production in a public research centre

The production of pharmaceuticals is one of the most highly regulated fields in terms of quality. The body of good manufacturing practice (GMP) represents the standard required by law; GMP embraces the guidelines that regulate all activities related to the production and quality control of medicinal products for human and veterinary use. This paper deals with the implementation of a quality management system (QMS) in compliance with GMP and ISO 9001 standards for the production and distribution of radiopharmaceuticals in a public research institute. The production of 2-[18F]fluoro-2-deoxy-d-glucose has been implemented according to GMP standards and has been licensed by the national Authority in 2007. In 2010, a project to orient the system??s GMP compliance to ISO 9001 standards has been approved. A QMS conforming to ISO 9001:2008 should be considered an important additional step in terms of quality, because ISO 9001 also takes into account economic and financial aspects, design and development aspects and introduces management review for measurement and analysis of the process with the aim of improving performances. The harmonization between GMP and ISO has been defined following the Pharmaceutical Quality System Q10 guideline developed by International Conference on Harmonization.     

Implementation of a quality management system in meteorological practice in Serbia

An optional approach in the meteorological service Quality Management System (QMS) based on the case study of the Republic Hydrometeorological Service (MHS) of Serbia is presented and discussed in this paper. The idea is to use the ISO/IEC 17025 standard as a base for its QMS development. Main reasons for such a decision and the elements of the implemented solution are presented and discussed. Meteorological testing processes of the MHS of Serbia and relevant ISO/IEC 17025 scope of accreditation are presented. After establishing competencies in meteorological, environmental, and hydrological testing, the MHS of Serbia will develop an integrative ISO 9001 QMS. The Serbian case study could be taken into consideration as one of the options related to the future World Meteorological Organization Quality Management Framework.     

Implementation of a quality system in a clinical laboratory

The effects of a quality system are measured with the aid of quality indicators, which can be used for both decision-making by the management of the laboratory and for process control. The need for economic appraisal is stressed since the development of a quality system is very time- and labour-consuming. The aspects of both the customer and the personnel involved should be considered to evaluate the quality system. It is also important to define practical means to build up and maintain a quality system especially in smaller laboratories. For instance, simple tools to evaluate uncertainty of measurement and availability of inexpensive national reference materials are needed.     

Implementation of a quality management system in university test laboratories: a brief review and new proposals

Quality management systems are difficult to implement in university laboratories involved in teaching activities, R&D and provision of testing services, because of their peculiar characteristics. Testing services are not a priority, the performance of professionals is measured based on their teaching activities and publications, and the laboratories are shared with research and teaching activities. Hard efforts were made all around the world to overcome some of these difficulties. This paper analyzes the process of implementing a quality management system according to the ISO/IEC 17025 standard at two laboratories of the Federal University of Rio Grande do Sul, in Brazil. Some new solutions to solve the main problems typically originated on this type of environment are presented and compared with reports from the literature. It was concluded that it is perfectly possible for university laboratories to have their tests accredited according to standard ISO/IEC 17025, respecting their peculiarities and adopting creative solutions that meet the characteristics and the needs of each institution.     

Current experiences with a quality management system for non-clinical research and development in pharmaceutical industry

Quality management is one of the most important issues in pharmaceutical research as it determines the validity and reliability of data, data and data evaluation being the central products of all research activities. In this business it is of outstanding importance to generate valid data for the assessment of drug development candidates to assure that the huge financial investment, which is based on such assessments, can be successful. Efficacy and safety of products are the final goals of such developments. Therefore, Merck/Merck Serono implemented an additional specifically developed quality management system that covers all areas and locations in Merck Serono Research that were not yet regulated by an existing regulatory quality management system, e.g. GLP (Good Laboratory Practice). The system is known under the name Merck Serono Research-Quality Management System (MSR-QMS). Thus, we describe the implementation process of MSR-QMS as a research specific quality management system in a global company. Furthermore, the implementation process in one specific research department will be highlighted. Using a practical example, the validation of an analytical instrument in a MSR-QMS-regulated research laboratory will be shown and compared to a validation process in a strictly GLP-regulated area. A summary of the experiences with the new quality system will complete this article and the advantages of high quality research results in industry will be discussed.     

Need for quality management in research and development

 There is growing interest in setting up a general concept for quality management and quality control in research and development, which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea for a quality management system in all fields of research and development and will probably initiate broad discussion on this delicate topic. Received: 28 June 1998 · Accepted: 13 July 1998     

Implementation of the quality management system at the Laboratory of Radiological Protection and Safety (LPSR) in Portugal

The paper describes the activities carried out for the implementation of the quality management system (QMS) at the Laboratory of Radiological Protection and Safety (LPSR) in Portugal in order to achieve the management and technical requirements of ISO/IEC 17025:2005 and to get the accreditation for ten tests. The implementation of the QMS based on this international standard allowed LPSR to improve the methods, to identify problems, to implement preventive and corrective actions, to generate valid results and to achieve a stable level of high-quality output recognized by an independent body in the scope of waters, metrology, radiation and radiochemistry.     

Tracking and controlling everything that affects quality is the key to a quality management system

Every laboratory has a need to track and control the variables that drive the quality of the results. However, each laboratory is unique and what one organization deems to be a critical process to track and control will likely differ from other organizations. Furthermore, there is more than just the end product or result that needs to be tracked and controlled. All of the intermediate products and resources play a significant role in producing the final product and each of these needs to be included in the LIMS. At a high level, this article will present ideas and opinions on the following topics in relation to implementing a LIMS process tracking and control system in a laboratory: The difference between tracking and controlling processes; What to track and control in the lab; The "product" of the laboratory; Preventing mistakes in a laboratory; Comprehensive software platform options; The value of seeing a system as opposed to imagining it; The use of barcodes in the laboratory; and an assessment on using the Risk Based Approach in deciding what to include in the tracking system.     

Point-of-care testing: Implementation and practice of cost-effective total quality management

In the United States of America, point-of-care testing (POCT) generally is defined as laboratory testing performed at or near the patient. The objective is to have results immediately available to clinicians for timely medical intervention. The widespread use of POCT is, in part, a response to advances in technology and increased patient acuity. Theoretically, in the context of the entire health care system, POCT improves "quality" by promoting cost through quicker diagnosis and treatment, which in turn leads to faster recovery, reduced length of stay, more efficient clinicians, and overall better utilization of resources. Total quality management (TQM) generally is associated with improving processes and, therefore in this context, improving patient outcomes. The TQM philosophy focuses on creating products or services, which meet or exceed customer expectations. The successful implementation of POCT in a manner consistent with TQM principles requires assessment of direct, measurable benefits including cost-effectiveness to the health care system.     

Quality assurance in research: incorporating ISO9001:2000 into a GMP quality management system in a pharmaceutical R+D+I center

There is currently no universal or standardized quality system for the recognition of excellence of a research center. Knowledge and competence may not be enough in the current rapidly changing world in which high productivity and continuous improvement are essential. The purpose of this study was to assess the impacts of implementing the ISO9001:2000:2000 standard in an academic research center dedicated to R+D+I (research, development and innovation) in the pharmaceutical industry. The article describes the stages we followed to implement the ISO9001:2000 system, which was achieved by integrating it into the previous regulatory system of GMP (Good Manufacturing Practices). As a result of implementing ISO9001:2000, the center has seen distinct improvements, such as fewer errors in project documentation, improved assessment of customer satisfaction, and the effective implementation of periodic plans, e.g., in calibration, preventive maintenance, and investments. Overall, ISO9001:2000 implementation has been beneficial for the organization and could be applied to other research centers.     

Implementation of quality assurance system to enhance reliability in Chinese handwriting examination

In regard to the tightened standard on the acceptance of forensic evidence at courts, in particular the evidence-based opinion, the forensic community worldwide is striving to improve test reliability through the implementation of quality assurance system. Handwriting examination including Chinese handwriting is a typical traditional forensic discipline that has often been subjected to judicial challenges in courts. In this paper, we present the work practice and the quality control procedure for Chinese handwriting examination in accordance with ISO/IEC 17025, an international standard on general requirements for the competence of testing and calibration laboratories. The examination work constitutes various phases of identification of the characteristic writing features, comparison and evaluation of the significant similarities and differences, interpretation of findings and formation of opinions. With the support of a fit-for-the-purpose quality system complying with the ISO standard, document examiners in this laboratory are obliged to address the criteria as stated in the pre-set quality assurance plan and undertake scrupulous efforts in delivering the scientific work at all stages throughout their examinations. By doing so, personal bias and other subjective factors that cause detrimental influence to the formation of expert opinions would be kept to a minimum.     

Application of synthetic reference materials in the medical radiological research centre

The contents of 21 chemical elements (Ag, Br, Ca, Cl, Co, Cr, Cs, Fe, Hg, K, Mg, Mn, Na, P, Rb, Sb, Sc, Se, Sr, Zn, Zr) in synthetic reference materials (SRMs) were compared with those in natural reference materials (NRMs) using short- and long-lived radionuclides. SRMs called synthetic standards (SSs) and synthetic standards, biological (SSBs) were prepared on the basis of phenol-formaldehyde resol resins in the Institute of Physics, Georgian Academy of Science. The NRMs included such IAEA reference materials as H-4 (animal muscle), A-13 (animal blood), H-5 (animal bone), SL-1 (lake sediment), SOIL-7 (soil), A-9 (mixed human diet), and IAEA-153 (milk powder). It was shown that SSB-SRMs possessed good representativity of the 30–50 mg tablets, high precision, operational convenience, and could be recommended for the INAA of a wide range of medico-biological and bioecological objects.     

A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories

The introduction of quality management systems (QMS) and the accreditation of laboratories according to ISO/IEC 17025 standard are not easy tasks, mainly for those laboratories located at teaching and research institutions. During the implementation of QMS at two testing laboratories of the Federal University of Rio Grande do Sul in Brazil, new solutions to overcome some of the difficulties inherent to this type of environment have been found. The knowledge acquired through this work has led to the proposition of some general steps incorporating a process approach presented in this article, which could be of use to laboratories in their pursuit for accreditation. This proposal suggests the use of strategic planning information, links the QMS objectives to the corresponding processes and sets a few indicators to monitor both performance of and improvements to the system.     

ISO 17025 quality system in a university environment

The experience of working under an ISO 17025 compliant quality system in a university environment is described in the example of the Testing Centre of University of Tartu. University-specific features of the quality system include that the Testing Centre acts as the “quality system server” for other units of the university and graduate students participate in the work carried out under the quality system. The benefits for the university and the graduate students are discussed. It is concluded that implementation of an ISO 17025 compatible quality system in a university is fully accomplishable and gives significant added value to the university by helping to destroy the ivory tower perception about universities and by introducing real-world flavour into the studies and broaden the minds (quality awareness) of the students.     

Step-by-step implementation of a quality system in the laboratory

In recent years laboratories have undergone huge transformations due to the technological development of inspection and testing equipment; the introduction of computerised and automated systems; keen competitiveness between companies/laboratories as a result of demand within Europe and on the international market; and greater consumer awareness of the quality of the products available. Laboratory accreditation, though a voluntary process, is formal recognition by an accreditation body of the laboratory's competence to carry out certain tests. This article presents those aspects which should be taken into account in the step-by-step implementation of a quality system and also makes reference to the requirements for the operation of accredited laboratories in accordance with European Standard EN 45001.     

Total quality management in hematology

 Healthcare is changing and clinical laboratory testing must change with it. In no discipline is this change more profound than in hematology. The principles of total quality management (TQM) including continuous quality improvement, reengineering and strategic planning can facilitate these changes. In the past, hematology has often been exlcuded from these processes due to its many manual procedures and the degree of expertise and skill needed to perform the testing. As automated technology continues to evolve, hematology testing, like other testing, will become integrated into the core, clinical laboratory. We suggest TQM can, and should, guide the way. Received: 15 April 2000 · Accepted: 19 April 2000     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.

     

The quality-management system in research implemented in the food and food process quality research laboratory of the French Food Safety Agency

The French Food Safety Agency is a public body incorporating 12 laboratories that perform research to support expertise and public decisions taken in the fields of sanitary safety of food, animal health, and veterinary drugs. On the request of the General Management of the Agency a quality-management system in research (QMSR) is being implemented in the Food and Food Process Quality Research Laboratory. The experimental QMSR is based on existing standards and documents, describing the provisions required for scientific and technical competence, quality management, and project management. Furthermore, this QMSR also incorporates specific notions of great importance for research activities such as the positive and negative non-conformities, the non-confirmation of hypotheses, and the principle of evaluation of a research activity by peers for both quality and scientific aspects.     

Determination of natural radioactivity in public drinking water quality assessment

The determination of ₉₀Sr and the gross particleactivity originating from radium isotopes was performed on water samples atvarious stages of treatment taken from water treatment plants before distributionto the consumers.