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vich-gl49-risk-assessment-studies-for-veterinary-medicinal-product-residues
Pesticide & Veterinary Drug Residues AOAC 2003.06 Chloramphenicol residue analysis in honeyAOAC 2004.08 Hormone residue detection in eggsAOAC 2006.03 Quantitation of residues in dairy productsAOAC 2007.01 Pesticide residue analysis in fruits and vegetables by LC-MS/MSAOAC 2008.05 Veterinary residue analysis in milk powderAOAC 2009.01 Pesticide residues in cocoa and chocolateAOAC 2010.01 Multiresidue analysis of pesticides in baby foodAOAC 2011.23 LC-MS/MS determination of sulfonamides in meatAOAC 2014.10 Tetracycline residues in fish and shellfish by ELISAAOAC 2015.06 Detection of pesticide residues in honey and bee productsAOAC 2016.04 Veterinary drug testing in poultry productsAOAC 2016.09 Veterinary drugs in seafood samplesAOAC 2017.02 Fluoroquinolone residue detection in beefAOAC 2017.09 Pesticide residues in citrus fruitsAOAC 2018.03 Veterinary drug residues in milk by LC-MS/MSAOAC 2018.09 Detection of macrolides in pork and beefAOAC 2019.02 Detection of β-lactam antibiotics in bovine milkAOAC 2020.04 LC-MS analysis of antiparasitics in sheep meatAOAC 2020.05 Multi-class pesticide screening in tea leavesAOAC 2021.06 Veterinary residues in dried meat productsAOAC 2022.01 Carbamate detection in vegetablesAOAC 2023.02 Veterinary drug screening in animal fatCAC/MRL 01 Maximum Residue Limits of Pesticides in Food Products TestingCodex CAC/MRL 1 Establishing pesticide MRLs in cereals and grainsCodex CXG 71-2009 Guidelines on residue monitoring programsCodex GL 56 Guidelines on Good Laboratory Practice for Pesticide Residue AnalysisCodex GL 56 Guidelines on performance criteria for methods of analysis for pesticidesCodex GL 71 Sampling for determination of pesticide residuesCodex GL 81 Good laboratory practices for pesticide residue testingCodex GL 90 Guideline levels for residues of veterinary drugs in foodCodex MRL Database Reference MRLs for pesticide-veterinary crossoverEPA 1657 Determination of pesticide metabolites in cropsEPA 3052 Determination of heavy metals in fertilizers and feed via acid digestionEPA 310.1 Herbicide detection in plant-based samplesEPA 314.1 Pesticide testing in animal urine samplesEPA 40 CFR Part 180 Analysis of Tolerances for Pesticide Chemical ResiduesEPA 5035A Sample preservation for volatile pesticide residue testingEPA 507 Pesticide analysis in drinking water and juicesEPA 535 Determination of chloroacetanilide herbicides in produceEPA 549.2 Aldicarb and related pesticide testing in plant tissueEPA 551.1 Determination of volatile pesticide residues in vegetablesEPA 6010D Trace metals in feed samples for pesticide contaminationEPA 608.3 Detection of pesticides in fat-rich animal tissuesEPA 8000C General protocols for pesticide residue identificationEPA 8081B Organochlorine pesticide detection by gas chromatographyEPA 8141B Organophosphorus pesticides in food matricesEPA 8151A Herbicide testing in soil and agricultural produceEPA 8151B LC-MS/MS testing of veterinary pesticide synergy effectsEPA 8270E Determination of semi-volatile pesticide residues in foodEPA 8321B Analysis of polar pesticides in animal tissues by HPLC-MSEPA 8325B Emerging pesticide residues in herbal medicinesEPA 8327 LC-MS analysis of pesticide degradation products in meatEPA 8330A Analysis of nitroaromatic pesticide residues in grainEU 2002/657/EC Validation of analytical methods for veterinary drug residuesEU 2005/34/EC Identification of residues in fresh meatEU 2009/128/EC Sustainable use of pesticides in food safety testingEU 2018/782 Residue control plan for animal-based food productsEU 2021/601 Monitoring of pesticide residues in organic foodEU 2022/617 Harmonization of veterinary residue testing protocolsEU 37/2010 Annex II Veterinary medicine residue validationEU 37/2010 Veterinary drug residue limits in foodstuffs of animal originEU 396/2005 Compliance Testing for Pesticide Residues in Fruits and VegetablesEU 396/2005 Harmonized limits for pesticide residues in food and feedEU 396/2005 Maximum residue limits of pesticides in agricultural products testingEU 625/2017 Compliance testing of veterinary drugs in aquacultureEU 744/2004 Residue control measures in aquacultureEU 96/23/EC Monitoring substances in live animals and animal productsEU SANTE/11813/2017 Sampling procedures for pesticide testingEU SANTE/12682/2019 Pesticide residues determination by QuEChERS methodEU SANTE/2020/12830 Confirmatory methods for residue analysisFAO/WHO Manual of Pesticide Residue Analysis in Agricultural CommoditiesISO 13395 Nitrite/nitrate detection in vegetables and fruitsISO 15662 Pesticide residue screening using modified QuEChERSISO 15952 Pesticide residue testing in animal feedingstuffsISO 17094 Multiclass pesticide residue testing in oilseedsISO 17190 Detection of residues in fermented animal feedISO 18330 Pesticide and veterinary drug residue detection in herbsISO 18385 Measurement of pesticide residue cross-contaminationISO 1842 Analysis of pesticide residues in feed raw materialsISO 18512 Pesticide and antibiotic residues in animal dungISO 20418 Veterinary antibiotic residues in bovine serumISO 21010 Rapid screening for multi-class residues in animal tissueISO 21458 Screening of pesticide residues using multi-residue methodsISO 22855 Determination of pesticide degradation products in foodISO 22866 Determination of Spray Drift in Field Conditions for Pesticide ApplicationISO 22892 Analysis of persistent organic pollutants in livestockISO 23161 Screening of veterinary drug residues in eggsISO 23690 Determination of pesticide metabolites in animal feedISO 24662 Pesticide residue analysis in dried plant materialsISO 24687 Pesticide metabolite residue determination in poultryISO 25102 Multiresidue pesticide testing in spices and condimentsISO 6468 Pesticide residue analysis in water using liquid-liquid extractionJECFA Evaluation-Based Testing of Veterinary Drug Residues in Animal ProductsJECFA Pesticide residue risk evaluation for animal-derived productsJECFA Residue analysis of growth promoters in animal tissuesJECFA Residue evaluation of antibiotics in livestockJECFA Residue evaluation of veterinary drugs in cattle and poultryJECFA Residue limit setting for antimicrobials in livestockJECFA Risk assessment methodology for pesticide residue evaluationJECFA Risk-based residue evaluation for export commoditiesOECD TG 509 Residue Studies in Livestock for Veterinary Drugs DetectionSANCO/12495/2011 Method Validation for Pesticide Residue Analysis in Foods

VICH GL49 Risk Assessment Studies for Veterinary Medicinal Product Residues Laboratory Testing Service: A Comprehensive Guide

The VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service is governed by a set of international and national standards. These standards are developed and maintained by standard development organizations such as the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), and the European Committee for Standardization (CEN).

International Standards

  • ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories
  • ISO 22000:2018 - Food safety management systems - Requirements for any organization in the food chain
  • ICH Q2(R1):2016 - Validation of analytical procedures: Text and methodology
  • National Standards

  • EN ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories (European Union)
  • ASTM E2759-18 - Standard Practice for Risk-Based Sampling (United States)
  • TSE/ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes (Turkey)
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is a non-governmental organization that develops and publishes international standards. The ISO has developed a set of guidelines for laboratory testing, including the ISO/IEC 17025:2017 standard.

    The American Society for Testing and Materials (ASTM) is a non-profit organization that develops and publishes standards for various industries, including laboratory testing.

    The European Committee for Standardization (CEN) is a non-governmental organization that develops and publishes standards for the European Union.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulatory requirements, and industry practices. The ISO/IEC 17025:2017 standard, for example, was updated in 2017 to include new requirements for laboratory competence.

    Standard Compliance Requirements

    Laboratories that provide VICH GL49 risk assessment studies for veterinary medicinal product residues testing services must comply with the relevant international and national standards. This includes:

  • Meeting the technical requirements of the ISO/IEC 17025:2017 standard
  • Implementing a quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • Validating analytical procedures in accordance with the ICH Q2(R1):2016 guidelines
  • The VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service is required by various industries, including:

  • Veterinary medicine manufacturers
  • Pharmaceutical companies
  • Food safety regulators
  • Animal health organizations
  • Business and Technical Reasons

    The business and technical reasons for conducting VICH GL49 risk assessment studies for veterinary medicinal product residues testing include:

  • Ensuring the safety of animals and humans exposed to veterinary medicinal products
  • Meeting regulatory requirements for residue control
  • Maintaining product quality and reliability
  • Preventing economic losses due to product recalls or contamination
  • Consequences of Not Performing This Test

    The consequences of not performing this test include:

  • Failure to meet regulatory requirements
  • Risk of animal and human health impacts
  • Economic losses due to product recalls or contamination
  • Damage to reputation and brand image
  • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control aspects of the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service include:

  • Validating analytical procedures in accordance with the ICH Q2(R1):2016 guidelines
  • Maintaining a quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • Implementing a document control procedure to ensure accurate and up-to-date documentation
  • Risk Factors and Safety Implications

    The risk factors and safety implications of veterinary medicinal product residues include:

  • Risk of animal health impacts, such as toxicity or allergic reactions
  • Risk of human health impacts, such as foodborne illnesses or environmental contamination
  • Economic losses due to product recalls or contamination
  • Damage to reputation and brand image
  • The VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service involves the following steps:

    1. Sample collection: Collecting representative samples of veterinary medicinal products

    2. Sample preparation: Preparing samples for analysis, including extraction and purification procedures

    3. Analytical procedure: Conducting analytical procedures to detect and quantify residues

    4. Data analysis: Analyzing data to determine residue levels and risk assessment

    5. Reporting: Documenting test results in a clear and concise manner

    Testing Equipment and Instruments

    The testing equipment and instruments used for the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service include:

  • Gas chromatography (GC) systems
  • Liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems
  • Sample preparation equipment, such as centrifuges and homogenizers
  • Test Procedure

    The test procedure for the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service includes:

    1. Receiving samples: Receiving representative samples of veterinary medicinal products

    2. Preparing samples: Preparing samples for analysis, including extraction and purification procedures

    3. Conducting analytical procedures: Conducting analytical procedures to detect and quantify residues

    4. Analyzing data: Analyzing data to determine residue levels and risk assessment

    5. Reporting results: Documenting test results in a clear and concise manner

    Reporting Test Results

    The reporting of test results for the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service includes:

  • Providing clear and concise documentation of test results
  • Meeting regulatory requirements for residue control
  • Maintaining confidentiality and intellectual property rights
  • Continuity and Availability

    To ensure continuity and availability, laboratories providing VICH GL49 risk assessment studies for veterinary medicinal product residues testing services should have the following in place:

  • A quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • A document control procedure to ensure accurate and up-to-date documentation
  • A continuous improvement plan to update analytical procedures and equipment as needed
  • Test Validation

    To validate the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow the ICH Q2(R1):2016 guidelines for validation of analytical procedures
  • Conduct method validation and verification studies to ensure accuracy and reliability
  • Perform regular maintenance and calibration of equipment to ensure optimal performance
  • Method Validation

    To validate methods used in the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow the ICH Q2(R1):2016 guidelines for validation of analytical procedures
  • Conduct method validation and verification studies to ensure accuracy and reliability
  • Perform regular maintenance and calibration of equipment to ensure optimal performance
  • Test Results Evaluation

    To evaluate test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow regulatory guidelines for residue control
  • Evaluate data to determine residue levels and risk assessment
  • Document test results in a clear and concise manner
  • Standardization of Test Results

    To standardize test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow regulatory guidelines for residue control
  • Use standardized analytical procedures to ensure accuracy and reliability
  • Maintain accurate and up-to-date documentation of test results
  • Availability of Standardized Test Results

    To ensure availability of standardized test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Maintain a quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • Document test results in a clear and concise manner
  • Ensure continuous improvement and updates to analytical procedures and equipment as needed
  • Reporting Test Results

    To report test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow regulatory guidelines for residue control
  • Provide clear and concise documentation of test results
  • Maintain confidentiality and intellectual property rights
  • Continuity of Service

    To ensure continuity of service, laboratories providing VICH GL49 risk assessment studies for veterinary medicinal product residues testing services should have the following in place:

  • A quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • A document control procedure to ensure accurate and up-to-date documentation
  • Continuous improvement plan to update analytical procedures and equipment as needed
  • Availability of Test Results

    To ensure availability of test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Maintain a quality management system (QMS) that meets the requirements of the ISO 9001:2015 standard
  • Document test results in a clear and concise manner
  • Ensure continuous improvement and updates to analytical procedures and equipment as needed
  • Test Results Validation

    To validate test results from the VICH GL49 risk assessment studies for veterinary medicinal product residues laboratory testing service, laboratories should:

  • Follow regulatory guidelines for residue control
  • Evaluate data to determine residue levels and risk assessment
  • Document test results in a clear and concise manner
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