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Good Laboratory Practice (good + laboratory_practice)

Distribution by Scientific Domains

Medical Sciences	13%

Selected Abstracts

Levels of quality management of blood transfusion services in Europe

ISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2008
C. Seidl
The European blood legislation has defined several key quality elements to achieve Good Manufacturing Practice (GMP) in the field of blood transfusion. During the recent years, the blood legislation is in the process of implementation throughout its member states. Following the Directive 2002/98/EC, Directive 2005/62/EC has given further requirements for quality-management systems to be fulfilled by blood establishments. In addition, GMP/Good Laboratory Practice (GLP) and ISO standards are used inter alia by blood establishments. In order to support the implementation of the blood legislation, the European Public Health Work Plan (2005/2007) has cofunded two projects, led by the German Red Cross and supported by the European Blood Alliance, delivering a common European Standard Operating Procedure (SOP) methodology (EU-Q-Blood-SOP) and criteria and standards for the inspection of blood establishments (EUBIS). The EU-SOP manual will assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU Directive 2002/98/EC and its technical annexes. The standards and criteria for inspection of blood establishments will cross-reference existing quality standards to the directive requirements and define requirements for the structure of quality-management systems based on the directive 2002/98/EC and its technical annexes. Based on these requirements, inspection standards and criteria are developed to assist in the independent assessment of quality systems established by individual blood establishments. These assessments are done in relation to the requirements defined by the European Union legislation on blood, in order to safeguard the quality of blood and to achieve continuous improvement of its quality throughout Europe. [source]

The journey of Indian GLP programme,looking back and forward

QUALITY ASSURANCE JOURNAL, Issue 1 2009
V. Amalan Stanley
Abstract The Indian GLP (Good Laboratory Practice) compliance monitoring programme has successfully brought the task of implementing the programme to the foreground where full OECD (Organization for Economic Cooperation and Development) membership is about to happen. It has been a long journey, more than five years for the programme to arrive at this juncture, succeeding through sheer commitment and will of the Science and Technology initiatives under which the programme has been implemented. Considering the spontaneous and natural challenges that are bound to make the effort of implementing the GLP compliance programme tougher for any country, the progress made by the Indian GLP programme can be considered very rapid. Though the dawn of full OECD membership for the Indian GLP programme is imminent the paper deals with the details of the journey it has traveled so far and the challenges ahead, commending the commitment of the efforts of the GLP MA (Monitoring Authority) as well as the preparedness of the test facilities. This paper discusses the GLP policy aspects that favoured the growth of the programme among non-member adherents, such as the allowance for getting GLP certification by GLP MA abroad. It also deals with the challenge of harmonizing the policies of the internal agencies that have direct influence on the implementation of the GLP programme, other than legalizing the GLP aspects as there are various government departments in India dealing with the regulatory aspects of specific drug products for human use or that are of chemical in origin. There are data requirements made mandatory by these institutions on pre-clinical or non-clinical safety evaluation of those products, which invariably necessitate studies conducted in compliance with the principles of GLP. The paper concludes with the emphasis that there is a primary need for harmony as well as legal or judicial underpinnings under the umbrella of a national GLP Monitoring Authority, a gray area to be essentially tackled with foresight, to earn credibility on the international front. Copyright © 2009 John Wiley & Sons, Ltd. [source]

Good Laboratory Practice (GLP), guidelines for the validation of computerised systems,

QUALITY ASSURANCE JOURNAL, Issue 3-4 2007
Peter M. Esch
Abstract The aim of this document is to provide guidance on the validation of computerised systems, compliant with Good Laboratory Practice (GLP). It specifies more precisely the procedures to follow in carrying out validations of computerised systems. It intends to help test facilities promote a common standard. However, the test facility management may use different approaches, as long as they are in compliance with the Organisation for Economic Co-operation and Development (OECD) Principles of GLP [1]. The extent of a validation may vary depending on the complexity of the computerised system. In any case the validation should demonstrate that the computerised system is suitable for its intended purpose. The Arbeitsgruppe Informations-Technologie (AGIT) is a working group consisting of representatives from Swiss industry and Swiss GLP monitoring authorities with the aim of proposing procedures that are practical for use in test facilities fulfilling GLP regulatory requirements. These guidelines have been adapted to current practices and replace those issued in June 2000. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Does the MAD system make test facilities mad?

QUALITY ASSURANCE JOURNAL, Issue 4 2006
V. Amalan Stanley
Abstract There needs more clarity in ad hoc Good Laboratory Practice (GLP) certification conferred to test facilities of non-member economies. There is a similar kind of issue with the ,GLP status' of the test data generated by a test facility that has been conferred GLP certification by the country that is only a provisional adherent. In both cases, the objective of the Mutual Acceptance of Data (MAD) system will not be fulfilled if the answer is ,no'. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Special requirements for GLP studies with ,big' animals,

QUALITY ASSURANCE JOURNAL, Issue 2 2006
Norbert Hochheimer
Abstract The article describes the special requirements for Good Laboratory Practice (GLP) studies with farm animals. Typically, GLP studies are conducted with small laboratory animals such as mice, rats and guinea pigs; GLP studies with big animals are rarely performed. This paper highlights the differences in housing and handling for small and big animals and discusses areas specific to GLP studies with farm animals. While the article draws on observations made and regulations applicable in Germany, the information may be useful for assessing GLP studies with large animals in other countries. Copyright © 2006 John Wiley & Sons, Ltd. [source]

Good Laboratory Practice (GLP);

QUALITY ASSURANCE JOURNAL, Issue 1 2006
initialling;
The aim of the present document is to provide guidance on the Good Laboratory Practice (GLP)-compliant acquisition and processing of electronic raw data. The life cycle of electronic raw data and their related meta data from the data acquisition to the data processing and the generation of results is shown. The different roles and responsibilities for data entry, data editing, data approval, and data freezing are specified. The requirements for time stamps, audit trails, and the identification of acting persons are described. Furthermore different levels of laboratory instrument integration in a LIMS are discussed. This document is intended to aid test facilities, and to promote the use of a common standard, but it should not be considered as a legally binding document. These guidelines may evolve with experience over the next few years and may be modified to reflect interpretations made by other Organisation for Economic Co-operation and Development (OECD) member countries. The present guidelines were prepared by the Working Group on Information Technology (Arbeitsgruppe Informationstechnologie, AGIT). This group consists of representatives from Swiss industry and the Swiss GLP monitoring authorities. Copyright © 2006 John Wiley & Sons, Ltd. [source]

GIQAR position paper on ,Archiving and Good Laboratory Practice',

QUALITY ASSURANCE JOURNAL, Issue 4 2005
M. M. Brunetti
Abstract Archiving of documents and specimens generated during a non-clinical laboratory study is a basic Good Laboratory Practice (GLP) requirement. The records and materials that should be archived as well as the characteristics and the organisation of archive facilities are addressed in the OECD Series on Principles of Good Laboratory Practice No. 1 (OECD Principles of Good Laboratory Practice (as revised in 1997) [1]. However, in recent years, questions concerning archiving have been raised and the need for a more detailed guidance on this matter has become evident The aim of the Society for Applied Pharmacological Sciences/Italian Group of Quality Assurance in Research (SSFA/GIQAR) working group on ,Archiving according to GLP' was to issue a position paper, present it for discussion in an ad hoc round table with representatives of the Italian GLP monitoring authority to promote common standards and to provide additional recommendations on storage and retention of records. Copyright © 2005 John Wiley & Sons, Ltd. [source]

Management tools for the evaluation of compliance and costs in the production of chemical,pharmaceutical companies

QUALITY ASSURANCE JOURNAL, Issue 3 2005
Franziska Rank
Abstract Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical,pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical,pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright © 2005 John Wiley & Sons, Ltd. [source]

The road to compliance with electronic records and electronic signature rules

QUALITY ASSURANCE JOURNAL, Issue 4 2003
Kathleen L. Reed
Abstract Activities required for compliance with electronic records (e-records) and electronic signatures (e-signatures) rules go a long way toward meeting the Good Laboratory Practice (GLP) requirements for assuring the quality of the data collected and the overall integrity of the study. This paper describes one facility's journey on the road to compliance. Copyright © 2003 John Wiley & Sons, Ltd. [source]

Principles in quality assurance.

QUALITY ASSURANCE JOURNAL, Issue 1 2003
Part 2.
Abstract In order to achieve and sustain effective compliance with the quality regulations, an understanding of the rationale for compliance must be developed throughout an organization. Developing such an organizational understanding is difficult to attain through training based solely on the text of the regulations or the company's Standard Operating Procedures (SOPs). These do have their place, but there is too much information, and the effects of training dissipate rapidly because personnel cannot effectively retain detailed information. In our organization, we undertook a process of simplification of the regulations, in an attempt to define the smallest number of basic quality principles that are embodied in Good Laboratory Practice (GLP) and associated regulations. The systematic application of these quality principles is a mechanism by which Quality Assurance (QA) can be clear and consistent in its monitoring and training activities. This process empowers all personnel to make correct compliance decisions without having to consult the detail of the regulations at every turn. The establishment and application of this concept at a bioanalytical contract research laboratory is described in this article. Copyright © 2003 John Wiley & Sons, Ltd. [source]

GLPs and medical devices

QUALITY ASSURANCE JOURNAL, Issue 2 2002
Linda Palagi Lynn
Abstract Applying Good Laboratory Practice (GLP) regulations to studies of medical devices and combination products (drug/device products) presents some unique challenges. The complexity of medical devices , which may be internal, external, or composed of many intricate parts including software, hardware, or drugs to perform their intended task , requires interpretation of the regulations. Further, the dynamics of the conduct of non-clinical laboratory studies for medical devices can be quite complex often involving a team of scientists, engineers, computer specialists, technicians, veterinarians, physicians, pathologists and equipment from both the test facility and sponsor. This article highlights areas of the GLP regulations and provides information and suggestions for GLP compliance for medical device studies. Copyright © 2002 John Wiley & Sons, Ltd. [source]

GIQAR position paper on ,Archiving and Good Laboratory Practice',

Current challenges for FDA-regulated bioanalytical laboratories for human (BA/BE) studies.

QUALITY ASSURANCE JOURNAL, Issue 1 2007
FDA GMP to bioanalytical laboratories, Part I: defining the appropriate compliance standards, application of the principles of FDA GLP
Abstract This article is the first of a three-part series that deals with current compliance issues/challenges for bioanalytical laboratories performing analysis for bioavailability/bioequivalence studies. Part 1 of this series provides the application of key elements from the Food and Drug Administration Good Laboratory Practices and the current Good Manufacturing Practices regulations as the framework for the implementation of sound quality systems in a bioanalytical laboratory to be in compliance with current regulatory expectations. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Evaluation of cottonseed meal derived from genetically modified cotton as feed ingredients for channel catfish, Ictalurus punctatus

AQUACULTURE NUTRITION, Issue 6 2008
M.H. LI
Abstract Three laboratory experiments were conducted to assess nutritional quality of cottonseed meals from genetically modified (GM) cotton crops, Roundup Ready® Flex, Bollgard® × Roundup Ready, Bollgard II® × Roundup Ready, and Bollgard II × Roundup Ready Flex for channel catfish, Ictalurus punctatus using Good Laboratory Practices. Growth, feed efficiency, survival, and fillet composition of catfish fed diets containing 20% cottonseed meal from these cotton products were compared with that of catfish fed diets containing cottonseed meals from the near-isogenic, non-GM control and non-GM commercial varieties. Juvenile catfish (mean weights of 4.1, 5.0, and 0.6 g per fish for Experiments 1, 2, and 3, respectively) were stocked in each of 80-L aquaria and fed experimental diets for 8 weeks. Although there were slight variations in proximate composition, amino acids, and gossypol concentrations, the GM cottonseed meals were not significantly different from the conventional control and the reference cottonseed meals. Weight gain, feed conversion, survival, and fillet composition of catfish fed GM cottonseed meals appeared similar to that of either the control or the commercial cottonseed meals. Results from the present study demonstrate that these GM cottonseed meals are nutritionally equivalent to conventional non-GM cotton varieties when fed to catfish at 20% of the diet. [source]

,Good laboratory practice' in diagnostic laboratories using nucleic acid amplification methods

CLINICAL MICROBIOLOGY AND INFECTION, Issue 5 2001
S. J. Furrows
No abstract is available for this article. [source]

History of FDA good laboratory practices

QUALITY ASSURANCE JOURNAL, Issue 3 2003
Anne M. Baldeshwiler
Abstract The United States Food and Drug Administration (FDA) requires nonclinical studies of new drugs, food additives and chemicals to predict their safety and potential efficacy in humans. The significance of the information gained from these studies requires that they be conducted according to sound scientific principles and with strict attention to quality assurance and quality control. Human health and safety are dependent upon the decisions made from these studies. The discovery of the lack of companies' adherence to these principles led to the development of the good laboratory practice (GLP) regulations, the driving force behind the quality of nonclinical laboratory studies. As the 25th anniversary of the publication of the regulations approaches, a description of the events leading to the proposal of the GLP regulations provides understanding about their significance and the importance of their use in assuring the quality and integrity of nonclinical safety data. Copyright © 2003 John Wiley & Sons, Ltd. [source]

Lyme borreliosis in Sweden , diagnostic performance of five commercial Borrelia serology kits using sera from well-defined patient groups

APMIS, Issue 1 2004
Brief report
Five commercial Borrelia serology kits available in Sweden were evaluated and compared for their diagnostic performance in sera from clinically well-characterized patient groups. With the clinically defined groups as the gold standard, i.e. without knowledge of antibody status in serum and cerebrospinal fluid, the diagnostic performance of the kits was compared and important differences in diagnostic usefulness were found. The kits from Abbot and DAKO, that often predict clinically relevant Borrelia infection and do not detect antibodies in sera from patients without strong suspicion of Borrelia infection, were considered the most useful in the population studied. This kind of validation study is an important part of good laboratory practice and should be performed by laboratories serving patient populations with varying endemicity of Borrelia. [source]

History of FDA good laboratory practices

Meeting the challenges of implementing good laboratory practices compliance in a university setting

QUALITY ASSURANCE JOURNAL, Issue 1 2002
Sandra Hancock
Abstract The number of university laboratories participating in good laboratory practices (GLP) studies is on the rise, as evidenced by the increase in university personnel that have joined the Society of Quality Assurance (SQA) during the past decade. However, the road to GLP compliance in the university setting has significant challenges. To evaluate how universities have implemented and managed GLP studies, a survey was conducted of SQA members with a university address. The results are described in this article. At Virginia-Maryland Regional College of Veterinary Medicine (VMRCVM), we have been participating in GLP studies since 1989. Studies are conducted by research or clinical faculty members, with quality assurance (QA) provided by the College Quality Assurance Unit. Since the inception of our GLP Program, VMRCVM has made significant progress toward meeting the challenges of regulatory compliance. Copyright © 2002 John Wiley & Sons, Ltd. [source]