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Verification Of Analytical Methods For Gmo Testing When Implementing Interlaboratory Validated Methods
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Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by : Institute for Health and Consumer Protection
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by Institute for Health and Consumer Protection and published by . This book was released on 2011 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.
Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by :
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by and published by . This book was released on 2017 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfil legal requirements, then this document will be amended accordingly.
Book Synopsis Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods by : Institute for Health and Consumer Protection
Download or read book Verification of Analytical Methods for GMO Testing when Implementing Interlaboratory Validated Methods written by Institute for Health and Consumer Protection and published by . This book was released on 2011 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the EU, method validation is an essential part of the process that regulates the introduction of new GMOs as food and/or feed into the market. When the inter-laboratory validation study is completed, the method is ready to be implemented in routine testing laboratories. When implementing the new method, the laboratory has to verify that the method can be used for its intended purpose (method verification). The scope of this document is to provide guidance on how to carry out the method verification. Despite the fact that several guidelines on method verification have been published, no specific guidelines are available for GMO detection. The aim of this guidance document is to harmonise the in-house verification of inter-laboratory validated methods for the qualitative and quantitative detection of GMOs, including element-, construct-, and event-specific methods. Considering that the Polymerase Chain Reaction (PCR) is the method of choice in the EU for the identification and quantification of GMOs, this document refers exclusively to real time PCR. However, if novel methods are subsequently developed that fulfill legal requirements, then this document will be amended accordingly.
Book Synopsis How to Reliably Test for GMOs by : Jana Žel
Download or read book How to Reliably Test for GMOs written by Jana Žel and published by Springer Science & Business Media. This book was released on 2011-10-26 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: The detection of genetically modified organisms (GMOs) is becoming very complex, with new GMOs, approved and unapproved, constantly entering world markets. Traceability and labelling of GMOs is defined in regulations worldwide, demanding accurate and reliable testing to support the requirements of legislation. This Brief provides the current state-of-the-art on all key topics involved in GMO testing and is a source of detailed practical information for laboratories. Special focus is given to qualitative and quantitative real-time PCR analysis relevant to all areas where detection and identification rely on nucleic acid-based methods. The following topics, important for testing laboratories, are also discussed: organization of the laboratory, focusing on aspects of the quality system and methods for testing, validation and verification of methods, and measurement uncertainty. The Brief also discusses the new challenges of GMOs and novel modified organisms, using new technologies, and the possible solutions for GMO detection, including bioinformatics tools. Finally, legislation on GMOs and sources of information on GMOs are provided, which are relevant not only to testing laboratories, but to anyone interested in GMOs. The authors of this Brief have many years of experience in GMO testing, development of real-time PCR methods, implementation of quality system requirements, validations and verification of methods, and measurement uncertainty. The National Institute of Biology is a highly qualified research laboratory and a National Reference Laboratory, which also performs routine analyses of food, feed and seed. The Institute for Health and Consumer Protection of the European Union Joint Research Centre has extensive knowledge and experience of GMO detection. It hosts the European Union Reference Laboratory for GM Food and Feed in addition to chairing the European Network of GMO Laboratories.
Book Synopsis Analytical Method Development and Validation by : Michael E. Swartz
Download or read book Analytical Method Development and Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2018-10-03 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.
Book Synopsis Analytical Method Validation and Instrument Performance Verification by : Chung Chow Chan
Download or read book Analytical Method Validation and Instrument Performance Verification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2004-04-23 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Book Synopsis Testing and Analysis of GMO-containing Foods and Feed by : Salah E. O. Mahgoub
Download or read book Testing and Analysis of GMO-containing Foods and Feed written by Salah E. O. Mahgoub and published by CRC Press. This book was released on 2019-01-15 with total page 329 pages. Available in PDF, EPUB and Kindle. Book excerpt: An increasing number of genetically modified organisms (GMOs) continues to be produced every day. In response to the concerns raised by the development of GMOs and their incorporation in foods and feed, guidelines and regulations to govern and control the use of GMOs and their products have been enacted. These regulations necessitated the design of methods to detect and analyse the presence of GMOs or their products in agriculture produce, food and feed production chains. Design of techniques and instruments that would detect, identify, and quantify GM ingredients in food and feed will help inspection authorities to relay reliable information to consumers who might be concerned about the presence of GM ingredients. Information generated by detection of GMOs in food and feed would be helpful for setting regulations that govern the use of GM components as well as for labeling purposes. Qualitative detection methods of GM-DNA sequences in foods and feeds have evolved fast during the past few years. There is continuous need for the development of more advanced multi-detection systems and for periodic updates of the databases related to these systems. Testing and Analysis of GMO-containing Foods and Feed presents updates and comprehensive views on the various methods and techniques in use today for the detection, identification and quantification of GMOs in foods and feed. The eleven book chapters cover recent developments on sample preparation techniques, immunoassays methods and the PCR technique used in GMO analysis, the use of biosensors in relation to GMO analysis, the application of nucleic acid microarrays for the detection of GMOs, validation and standardization methods for GMO testing, in addition to the type of reference material and reference methods used in GMO testing and analysis. Some of the ISO standards designed for identifying and detecting the presence of GM material in foods are also presented in the book.
Book Synopsis Practical Approaches to Method Validation and Essential Instrument Qualification by : Chung Chow Chan
Download or read book Practical Approaches to Method Validation and Essential Instrument Qualification written by Chung Chow Chan and published by John Wiley & Sons. This book was released on 2011-03-01 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
Book Synopsis Validation in Chemical Measurement by : Paul De Bièvre
Download or read book Validation in Chemical Measurement written by Paul De Bièvre and published by Springer Science & Business Media. This book was released on 2005-01-12 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the user of the measurement results.
Book Synopsis Testing and Analysis of GMO-containing Foods and Feed by : Salah E. O. Mahgoub
Download or read book Testing and Analysis of GMO-containing Foods and Feed written by Salah E. O. Mahgoub and published by CRC Press. This book was released on 2019-01-15 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: An increasing number of genetically modified organisms (GMOs) continues to be produced every day. In response to the concerns raised by the development of GMOs and their incorporation in foods and feed, guidelines and regulations to govern and control the use of GMOs and their products have been enacted. These regulations necessitated the design of methods to detect and analyse the presence of GMOs or their products in agriculture produce, food and feed production chains. Design of techniques and instruments that would detect, identify, and quantify GM ingredients in food and feed will help inspection authorities to relay reliable information to consumers who might be concerned about the presence of GM ingredients. Information generated by detection of GMOs in food and feed would be helpful for setting regulations that govern the use of GM components as well as for labeling purposes. Qualitative detection methods of GM-DNA sequences in foods and feeds have evolved fast during the past few years. There is continuous need for the development of more advanced multi-detection systems and for periodic updates of the databases related to these systems. Testing and Analysis of GMO-containing Foods and Feed presents updates and comprehensive views on the various methods and techniques in use today for the detection, identification and quantification of GMOs in foods and feed. The eleven book chapters cover recent developments on sample preparation techniques, immunoassays methods and the PCR technique used in GMO analysis, the use of biosensors in relation to GMO analysis, the application of nucleic acid microarrays for the detection of GMOs, validation and standardization methods for GMO testing, in addition to the type of reference material and reference methods used in GMO testing and analysis. Some of the ISO standards designed for identifying and detecting the presence of GM material in foods are also presented in the book.
Book Synopsis Report on the Use of EU Reference Methods and JRC Decision Tools for GMO Analysis by :
Download or read book Report on the Use of EU Reference Methods and JRC Decision Tools for GMO Analysis written by and published by . This book was released on 2017 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: To ensure harmonised scientific and technical approaches for GMO detection the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) at the Joint Research Centre (JRC) has developed a freely accessible database, called "GMOMETHODS" providing a state-of-the-art catalogue of EU reference methods for GMO analysis. The EURL GMFF launched in 2015 a survey to assess the use of these EU reference methods by the official GMO control laboratories in the EU and to collect information on non-EU reference methods possibly employed for the same purpose. The survey aimed also to verify if, and to which extent, laboratories use two decision supporting tools, the JRC GMO-Matrix and Event-Finder which are available on the web site of the EURL GMFF. The survey was also directed to verify the types and frequencies of modifications possibly implemented in the protocols of the validated methods used by the official control laboratories. Results from the survey indicate that almost all official control laboratories (98 %) are using eventspecific EU reference methods for quantifying GMOs while a lower number of laboratories is using EU reference methods for qualitative analyses (55 % for element-specific methods and 40 % for construct-specific methods). The use of qualitative non-EU reference methods for screening purposes may reflect the laboratory needs when facing rapid alert emergencies of quickly implementing analytical strategies for detecting non-authorised GM events. Indeed genetically modified crops have continued to increase globally, both in terms of approval status and event/trait diversification. In those cases methods validated in collaborative studies and having the status of EU-reference methods are generally not yet available. In the survey close to half of the respondents (41 %-47 %) declared also to employ to different extents the two JRC decision supporting tools, GMO-Matrix and Event-Finder. Interestingly the survey shows that almost half of the protocols of the reference methods used by the laboratories are somewhat adapted to laboratory specific conditions, mainly with respect to the master mix and the reaction volume of the polymerase chain reactions (PCR) while the primers and probes are never modified. In all cases, the impact of these modifications had been verified by the control laboratory to ensure the equivalence between the adapted and the original protocols. Without such proof, the laboratory would lose its mandatory accreditation. Moreover, participants in Comparative Testing schemes have achieve generally high score performance using those adapted methods suggesting that the modifications implemented do not affect analytical sensitivity, trueness and precision of the original protocols. The outcome of the 2015 survey reveals therefore that the combined efforts of the EURL GMFF and ENGL have been successful for enhancing harmonisation in quantitative GMO analysis by the adoption of scientific and technical approaches. This achievement allows the consistency of results for GM labelling and an equal-level playing field in the EU Member States.
Book Synopsis Handbook of Analytical Validation by : Michael E. Swartz
Download or read book Handbook of Analytical Validation written by Michael E. Swartz and published by CRC Press. This book was released on 2012-04-24 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Book Synopsis Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing by :
Download or read book Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing written by and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The document "Definition of Minimum Performance Requirements for analytical methods of GMO testing" (ENGL 2015) is a guidance developed by the ENGL and the EU Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF). It supports the development and validation of methods for GMO analysis submitted in the frame of applications for EU market authorisation of GMO products, as well as those to be used in the official control of food and feed. The guidance document provides definitions and requirements to assess the performance of the methods developed for the detection and quantification of GMOs based on real-time PCR. More recently, technologies like digital PCR were successfully applied in various fields for the quantification of nucleic acid molecules, including GMOs. Moreover, GM animals and products developed by means of so-called new genomic techniques (Broothaerts et al. 2021) are being released on the market and present additional challenges from the analytical viewpoint. Therefore, ENGL experts have extended the original method performance parameters for guiding users in the development and validation of digital PCR methods for GMO analysis. While the developments in the fields of GM animals and new genomic techniques are still evolving, in addition to the Minimum Performance Requirements guidelines also specific recommendations for methods for the detection and quantification of organisms with short genomic alterations and of GM animals are provided. Given that developments in the fields of GM animals and new genomic techniques are ongoing, these recommendations may be further elaborated in the future.
Book Synopsis DNA Techniques to Verify Food Authenticity by : Malcolm Burns
Download or read book DNA Techniques to Verify Food Authenticity written by Malcolm Burns and published by Royal Society of Chemistry. This book was released on 2019-10-14 with total page 251 pages. Available in PDF, EPUB and Kindle. Book excerpt: The food supply chain needs to reassure consumers and businesses about the safety and standards of food. Global estimates of the cost of food fraud to economies run into billions of dollars hence a huge surge in interest in food authenticity and means of detecting and preventing food fraud and food crime. Approaches targeting DNA markers have assumed a pre-eminence. This book is the most comprehensive and timely collection of material from those working at the forefront of DNA techniques applied to food authenticity. Addressing the new field of analytical molecular biology as it combines the quality assurance rigour of analytical chemistry with DNA techniques, it introduces the science behind DNA as a target analyte, its extraction, amplification, detection and quantitation as applied to the detection of food fraud and food crime. Making the link with traditional forensic DNA profiling and describing emerging and cutting-edge techniques such as next generation sequencing, this book presents real-world case studies from a wide perspective including from analytical service providers, industry, enforcement agencies and academics. It will appeal to food testing laboratories worldwide, who are just starting to use these techniques and students of molecular biology, food science and food integrity. Food policy professionals and regulatory organisations who will be using these techniques to back up legislation and regulation will find the text invaluable. Those in the food industry in regulatory and technical roles will want to have this book on their desks.
Book Synopsis Principles and Practices of Method Validation by : A Fajgelj
Download or read book Principles and Practices of Method Validation written by A Fajgelj and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 317 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
Book Synopsis Application of Sampling and Detection Methods in Agricultural Plant Biotechnology by : Ray Shillito
Download or read book Application of Sampling and Detection Methods in Agricultural Plant Biotechnology written by Ray Shillito and published by Elsevier. This book was released on 2022-07-30 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Application of Sampling and Detection Methods in Agricultural Plant Biotechnology describes detection methods for seed, plants and grain derived from biotechnology. This international handbook, based on a series of workshops carried out for governments in collaboration with ILSI and Co-published in partnership with the Cereals & Grains Association, provides the technical and practical information needed to develop, validate and use detection methods. This useful resource provides readers with the tools necessary to carry out reliable sampling, detection and interpretation of data. Presents a review of the technologies and approaches used for sampling and detecting biotechnology products in seed, plants, grain, food and feed Serves as a GM detection manual for international regulators and government agencies, testing laboratories, and academic and industrial professionals Contains case studies, applications, literature reviews and coverage of recent developments
Book Synopsis Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing by :
Download or read book Definition of Minimum Performance Requirements for Analytical Methods of GMO Testing written by and published by . This book was released on 2008 with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt: As laid down in the Annex of Commission Regulation (EC) No. 1829/2003 as amended by Commission Regulation (EC) No 1981/2006, and Annex 1 of Commission Regulation (EC) N. 641/2004, the Community Reference Laboratory for GM Food and Feed (CRL-GMFF) is responsible for the evaluation and validation of methods of analysis in the context of GMO authorisation under Commission Regulation (EC) No 1829/2003. The CRL-GMFF is assisted by the ENGL (European Network of GMO Laboratories). The ENGL recommends that the assessment, by the CRL-GMFF, of methods submitted by the applicants as part of the GMO authorisation process is undertaken in two distinct phases: Phase 1 - evaluation of the method performance data submitted by the applicant as part of the official dossier; and Phase 2 - evaluation of method performance data following a full validation study by collaborative trial. At present this document refers to polymerase chain reaction (PCR) based analytical methods for the determination and quantification of GMOs. However, if novel methods (e.g. those using technologies other than PCR) are subsequently developed that fulfil legal requirements then this document will be amended accordingly.
