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Laboratory Practice (laboratory + practice)

Distribution by Scientific Domains

Medical Sciences	25%
Education	9%

Kinds of Laboratory Practice

good laboratory practice

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]

Gazing at the Hand: A Foucaultian View of the Teaching of Manipulative Skills to Introductory Chemistry Students in the United States and the Potential for Transforming Laboratory Instruction

CURRICULUM INQUIRY, Issue 3 2005
STEPHEN DEMEO
ABSTRACT Many studies of chemistry have described the rise of the academic chemical laboratory and laboratory skills in the United States as a result of famous men, important discoveries, and international influences. What is lacking is a perspective of the manifestations of the balances of power and knowledge between teacher and student. A Foucaultian analysis of the teaching of manipulative skills to the introductory student in high school and college in the United States during the later half of the 19th and into the 20th century has provided such a perspective. The analysis focuses on the body, specifically students' hands, and how this body has been redescribed in terms of time, space, activity, and their combinations. It is argued in the first part of this article that the teaching of manipulative skills in the chemistry laboratory can be characterized by effects of differential forms of power and knowledge, such as those provided by Foucault's ideas of hierarchical observation, normalization, and the examination. Moreover, it is evident that disciplinary techniques primarily focused on the physical hands of the student have been recast to include a new cognitive-physiological space in which the teaching of manipulative skills currently takes place. In the second part of this article, the author describes his own professional development as a laboratory instructor through a series of reflective statements that are critiqued from a Foucaultian perspective. The personal narratives are presented in order to pro- vide science educators with an alternative way for their students to think about the relationship between one's manipulative skills and the quality of their data. The pedagogical approach is related to the maturation process of the chemist and contextualized in the current paradigm of laboratory practice, inquiry-based science education. [source]

Twenty years of external quality assurance in clinical cell analysis , A tribute to Jean-Luc D'Hautcourt

CYTOMETRY, Issue 1 2007
Bruno Brando
Abstract External quality assurance (EQA) programs in clinical cell analysis are now a consolidated item of laboratory practice. All the flow cytometric testings with an impact on clinical decision making have been submitted to regular EQA programs during the last 20 years, and this has produced internationally homogeneous guidelines, with a remarkable improvement in result reproducibility. Jean-Luc D'Hautcourt was a pioneer in this field, and his valuable contributions to flow cytometric method standardization and to the dissemination of the educational aspects of EQA programs are recognized. The different methodological approaches undertaken in the United States and Europe are discussed. The educational role of SIHON in the Benelux Countries and of UKNEQAS for Leucocyte Immunophenotyping worldwide is emphasized. Accredited and accreditating EQA programs require an impressive degree of organization and technical knowledge, so that only major international providers can afford such a task nowadays. However, small local studies still provide the necessary stimulus to the continuous improvement of the scientifical aspects of EQA schemes. © 2006 Clinical Cytometry Society [source]

Laboratory identification of factor VIII inhibitors in the real world: the experience from Australasia

HAEMOPHILIA, Issue 4 2010
E. J. FAVALORO
Summary., The laboratory has a key role in the initial detection of factor inhibitors and an ongoing role in the measurement of inhibitor titres during the course of inhibitor eradication therapy. The most commonly seen factor inhibitors are those directed against factor VIII (FVIII), usually detected either using the original or Nijmegen-modified Bethesda assay. In view of previously demonstrated high variability in laboratory results for inhibitor assays, we have more extensively examined laboratory performance in the identification of FVIII inhibitors. Over the past 3 years, we conducted two questionnaire-based surveys and two wet-challenge surveys utilizing eight samples comprising no FVIII inhibitor (n = 1), or low-titre (n = 2), medium-titre (n = 3) or high-titre (n = 2) FVIII inhibitor. Four samples were tested by 42 laboratories in 2007, and four by 52 laboratories in 2009. High inter-laboratory variation was evident, with CVs around 50% not uncommon, and some 10% of all laboratories (or around 15% of laboratories using Bethesda method) failed to detect low-level inhibitors of around 1 BU mL,1. Laboratories using the Nijmegen method appeared to perform better than those using a standard Bethesda assay, with lower evident assay variation and no false negatives. There was a wide variety of laboratory practice, with no two laboratories using exactly the same process for testing and interpretation of factor inhibitor findings. In conclusion, our study indicates that there is still much need for standardization and improvement in factor inhibitor detection, and we hope that our findings provide a basis for future improvements in this area. [source]

The molecular analysis of von Willebrand disease: a guideline from the UK Haemophilia Centre Doctors' Organisation Haemophilia Genetics Laboratory Network

HAEMOPHILIA, Issue 5 2008
S. KEENEY
Summary., von Willebrand disease (VWD) is a common autosomally inherited bleeding disorder associated with mucosal or trauma-related bleeding in affected individuals. VWD results from a quantitative or qualitative deficiency of von Willebrand factor (VWF), a glycoprotein that is essential for primary haemostasis and that carries and protects coagulation factor VIII (FVIII) in the circulation. Through characterization of the phenotype and identification of mutations in the VWF gene in patients with VWD, understanding of the genetics and biochemistry of VWF and VWD has advanced considerably. The importance of specific regions of VWF for its interaction with other components of the vasculature has been revealed, and this has facilitated the formal classification of VWD into three subtypes based upon quantitative (types 1 and 3) and qualitative (type 2) deficiency of VWF. The underlying genetic lesions and associated molecular pathology have been identified in many cases of the qualitative type 2 VWD variants (2A, 2B, 2M, 2N) and in the severe quantitative deficiency, type 3 VWD. However in the partial quantitative deficiency, type 1 VWD, the picture is less clear: there is a variable relationship between plasma levels of VWF and bleeding, there is incomplete penetrance and variable expressivity within affected families, the causative molecular defect is unknown in a substantial number of cases, and even in those cases where the causative mutation is known, the associated molecular pathology is not necessarily understood. This guideline aims to provide a framework for best laboratory practice for the genetic diagnosis of VWD, based upon current knowledge and understanding. [source]

Measurement of the setting expansion of phosphate-bonded investment materials: Part II , An evaluation of the Casting-Ring Test at 10 laboratories

JOURNAL OF ORAL REHABILITATION, Issue 7 2004
C. H. Lloyd
summary, The Casting-Ring Test has the potential to fulfil the requirement for a reliable ,Standard' test to measure the setting expansion of phosphate-bonded investment materials. The purpose of this study was to investigate the reproducibility of the measurements and the value that is produced at 10 test sites. The Casting-Ring Test apparatus, three phosphate-bonded investment products and one ring liner product were sent to the 10 participants, together with a detailed test protocol. Participants were asked to use their normal vacuum mixers. Reproducibility at individual sites was good. However, there were significant differences between test sites for the mean setting expansions, attributed to the range of vacuum mixers employed. From these results, the Casting-Ring Test appears to satisfy the requirements for adoption as an ISO standard test. The effect produced by different vacuum-mixer models would be manifest in any test. Not only does this have implications when determining the value of setting expansion for product information, but such a range of setting expansions will also be reproduced during production of moulds in commercial dental laboratory practice. However, for any specific product and vacuum-mixer combination, the setting expansion will be consistent and will not vary from mould to mould. [source]

Clinical measurement of thrombin generation by calibrated automated thrombography requires contact factor inhibition

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 11 2004
R. Luddington
Summary.,Background: Measurement of thrombin generation by calibrated automated thrombography (CAT) could fulfill the requirements of a global test of coagulability and is potentially applicable to routine clinical laboratory practice. The purpose of this study was to determine if corn trypsin inhibitor (CTI) could be used to abolish contact factor activation in this assay, thus allowing accurate measurement of low tissue factor (TF) concentration-triggered thrombin generation on samples taken in a routine clinical setting. Methods: The endogenous thrombin potential (ETP) was measured by CAT. Results: The study demonstrated that addition of CTI after plasma separation is not sufficient and blood must be drawn into tubes containing CTI if in-vitro contact factor-activated thrombin generation is to be abolished. Contact factor-activated thrombin generation is completely inhibited at a CTI concentration of 18.3 µg mL,1 whole blood. Increasing the CTI concentration above this level does not lead to suppression of the TF-triggered ETP. At a TF concentration of 2 pmol, ETPs were significantly lower in the presence of CTI (P < 0.001). The difference (no CTI minus CTI) between results ranged from ,,1 to 2159 nM min,1 (median ,,754). Whilst the low concentration TF-ETP assay was not optimized to distinguish degrees of coagulability between patient samples, there was a significant difference in ETP between normal and hemophilia samples and samples from patients with a clinical prothrombotic tendency. Conclusions: CTI can be applied to ETP measurement by CAT. This permits the use of CAT in a low TF-triggered thrombin generation assay without concern for the effect of interference from in-vitro contact factor activation and the optimum reagent conditions for using CAT as a global test of coagulability in clinical practice can now be defined. [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]

Analyzing ligand depletion in a saturation equilibrium binding experiment

BIOCHEMISTRY AND MOLECULAR BIOLOGY EDUCATION, Issue 6 2006
Enrique Claro
Abstract I present a proposal for a laboratory practice to generate and analyze data from a saturation equilibrium binding experiment addressed to advanced undergraduate students. [3H]Quinuclidinyl benzilate is a nonselective muscarinic ligand with very high affinity and very low nonspecific binding to brain membranes, which contain a high density of muscarinic receptors. These features allow the instructor to devote especial emphasis to evaluate ligand depletion, and therefore, stress the subtle but fundamental difference between total (added) ligand and free ligand concentration at equilibrium. [source]

Titrant standardizations: A research-oriented laboratory practice

BIOCHEMISTRY AND MOLECULAR BIOLOGY EDUCATION, Issue 2 2003
Tânia M. F. Günther
Abstract The quantitative character of biochemistry imposes some familiarization of the student with analytical practice in laboratory work and data analysis. This article describes the application of an inexpensive home-made precision titrator for titrant standardizations, introducing the students to amino acid and protein pH titrations and data analysis. [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]

Implementation of monoclonal antibody fluorescence on the Abbott CELL-DYN Sapphire haematology analyser: evaluation of lymphoid, myeloid and platelet markers

INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY, Issue 2 2006
B. JOHANNESSEN
Summary Apart from qualitative flags, that are typically inefficient and uninformative, haematology instruments provide little meaningful information about lymphocyte populations or the lineage of atypical or immature elements, The CELL-DYN Sapphire haematology analyser uses integrated optical and fluorescence (488 nm) measurements, with FL1 (FITC) and FL2 (PE) detectors being configured for fluorescent analysis. As monoclonal antibodies (Mab) are widely used as cellular probes, and are likely to constitute the future basis for immunodifferentials, we explored the feasibility of implementing immunofluorescence on this routine haematology analyser. An extensive series of Mab (CD2, CD3, CD4, CD8, CD11b, CD13, CD14, CD16, CD19, CD22, CD33, CD34, CD41, CD42b, CD45, CD56, CD61, CD64, CD235a and HLA-DR) were tested singly or in FITC/PE combinations. Analyser processing and data acquisition was achieved using CD-Sapphire automated CD61 immunoplatelet or CD3/4/8 assay procedures and, apart from mixing EDTA-blood and antibody, no further sample manipulation was required. Downloaded raw files were processed with cytometry software, and all evaluated reagents showed population discrimination analogous to flow cytometry. Practical procedures were straightforward and required minimal operator training. Extended information that can be obtained from monoclonal antibodies with a routine haematology analyser has the potential to extend haematology laboratory practices and positively impact laboratory and clinical efficiency. [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]

Protocols, practices, and the reproduction of technique in molecular biology*

THE BRITISH JOURNAL OF SOCIOLOGY, Issue 2 2002
Michael Lynch
ABSTRACT Protocols are one of the main organizational resources in molecular biology. They are written instructions that specify ingredients, equipment, and sequences of steps for making technical preparations. Some protocols are published in widely used manuals, while others are hand-written variants used by particular laboratories and individual technicians. It is widely understood, both in molecular biology and in social studies of science, that protocols do not describe exactly what practitioners do in the laboratory workplace. In social studies of science, the difference between protocols and the actual practices of doing them often is used to set up ironic contrasts between ,messy' laboratory practices and the appearance of technical order. Alternatively, in ethnomethodological studies of work, the difference is examined as a constitutive feature, both of the livedwork of doing technical projects, and of the administrative work of regulating and evaluating such projects. The present article takes its point of departure from ethnomethodology, and begins with a discussion of local problems with performing molecular biology protocols on specific occasions. The discussion then moves to particular cases in criminal law in which defense attorneys crossexamine forensic technicians and lab administrators. In these interrogations, the distinction between protocols and actual practices animates the dialogue and becomes consequential for judgments in the case at hand. The article concludes with a discussion of administrative science: the work of treating protocols and paper trails as proxies for actual ,scientific' practices. [source]