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ich-q3d-risk-based-assessment-of-elemental-impurities-in-leachables
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1079> Good Storage and Distribution Practices – Leachable RiskUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Laboratory Testing Service: A Comprehensive Guide

The ICH Q3D risk-based assessment of elemental impurities in leachables is a critical testing service that ensures the safety and quality of pharmaceutical products. This article will provide an in-depth understanding of the relevant standards, regulatory framework, and industry requirements for this testing service.

Relevant Standards:

  • ISO 17025:2018 (General Requirements for the Competence of Testing and Calibration Laboratories)

  • ICH Q3D (Impurities: Guideline for Elemental Impurities)

  • ASTM E1617-17 (Standard Practice for Conducting an Interlaboratory Study to Evaluate the Measurement Uncertainty Associated with a Test Method)

  • EN 15593:2008 (Leachables testing for pharmaceutical products)

    • Legal and Regulatory Framework:

    The ICH Q3D guideline provides a framework for evaluating and controlling elemental impurities in pharmaceutical products. This guideline is adopted by regulatory agencies worldwide, including the US FDA, EMA, and PMDA. The EU GMP (Good Manufacturing Practice) guidelines also specify requirements for leachables testing.

    International and National Standards:

  • ISO 17025:2018 is a widely recognized standard that ensures laboratories are competent to perform specific tests.

  • ASTM E1617-17 provides guidance on conducting interlaboratory studies to evaluate measurement uncertainty.

  • EN 15593:2008 specifies requirements for leachables testing.

    • Standard Development Organizations and their Role:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Standardization)

    • These organizations develop standards that ensure consistency, reliability, and safety in laboratory testing.

    How Standards Evolve and Get Updated:

    Standards are reviewed and updated periodically to reflect changes in technology, regulatory requirements, or industry needs. This ensures that laboratories remain competent and compliant with the latest regulations.

    Standard Compliance Requirements for Different Industries:

  • Pharmaceuticals

  • Cosmetics

  • Food Industry

    • Each industry has specific requirements for leachables testing, and compliance with relevant standards is essential for ensuring product safety and quality.

    ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Testing: A Comprehensive Guide

    The ICH Q3D risk-based assessment of elemental impurities in leachables is a critical testing service that ensures the safety and quality of pharmaceutical products. This section will provide an in-depth understanding of why this specific test is needed and required.

    Why this Specific Test is Needed and Required:

  • Ensures product safety and quality

  • Complies with regulatory requirements

  • Demonstrates industry compliance

    • The ICH Q3D guideline provides a framework for evaluating and controlling elemental impurities in pharmaceutical products. This guideline is adopted by regulatory agencies worldwide, including the US FDA, EMA, and PMDA.

    Business and Technical Reasons for Conducting ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Testing:

  • Ensures product safety and quality

  • Complies with regulatory requirements

  • Demonstrates industry compliance

    • The ICH Q3D risk-based assessment of elemental impurities in leachables is a critical testing service that ensures the safety and quality of pharmaceutical products.

    Consequences of Not Performing this Test:

  • Regulatory non-compliance

  • Product recalls

  • Reputation damage

  • Financial losses

    • Non-compliance with regulatory requirements can have severe consequences for industries, including product recalls, reputation damage, and financial losses.

    Industries and Sectors that Require this Testing:

  • Pharmaceuticals

  • Cosmetics

  • Food Industry

    • Each industry has specific requirements for leachables testing, and compliance with relevant standards is essential for ensuring product safety and quality.

    Risk Factors and Safety Implications:

  • Elemental impurities can be toxic or carcinogenic

  • Leachables can migrate into the final product

  • Failure to test for elemental impurities can result in regulatory non-compliance

    • Elemental impurities can pose serious health risks, including toxicity and carcinogenicity. Leachables testing ensures that these contaminants are identified and controlled.

    Quality Assurance and Quality Control Aspects:

  • Laboratory accreditation (ISO 17025)

  • Competence of personnel

  • Equipment calibration and maintenance

  • Data management and recording

    • Laboratories must be accredited to ISO 17025, demonstrating their competence in performing specific tests. Personnel must be trained and qualified for the testing process.

    How this Test Contributes to Product Safety and Reliability:

  • Ensures product safety and quality

  • Complies with regulatory requirements

  • Demonstrates industry compliance

    • The ICH Q3D risk-based assessment of elemental impurities in leachables is a critical testing service that ensures the safety and quality of pharmaceutical products.

    ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Laboratory Testing Service: A Comprehensive Guide

    Laboratory Accreditation (ISO 17025):

    Laboratories must be accredited to ISO 17025, demonstrating their competence in performing specific tests. This ensures that laboratories are competent and compliant with the latest regulations.

    Competence of Personnel:

    Personnel must be trained and qualified for the testing process. They must have a thorough understanding of the test method and its limitations.

    Equipment Calibration and Maintenance:

    Equipment used for leachables testing must be calibrated and maintained regularly to ensure accuracy and reliability.

    Data Management and Recording:

    Data management and recording are critical aspects of leachables testing. Laboratories must maintain accurate records of test results, including sample identification, testing conditions, and analytical data.

    ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Laboratory Testing Service: A Comprehensive Guide

    Why Choose Our ICH Q3D Risk-Based Assessment of Elemental Impurities in Leachables Laboratory Testing Service?

    At Company Name, we offer a comprehensive ICH Q3D risk-based assessment of elemental impurities in leachables laboratory testing service. Our team of experts has extensive experience in leachables testing and is committed to ensuring the safety and quality of your products.

    Our Services:

  • Leachables testing (EN 15593)

  • Elemental impurities analysis (ICH Q3D)

  • Regulatory compliance

  • Quality assurance and control

    • We offer a range of services, including leachables testing, elemental impurities analysis, regulatory compliance, and quality assurance and control. Our team is committed to ensuring the safety and quality of your products.

    Conclusion:

    The ICH Q3D risk-based assessment of elemental impurities in leachables is a critical testing service that ensures the safety and quality of pharmaceutical products. At Company Name, we offer a comprehensive laboratory testing service that meets the needs of industries worldwide.

    Please contact us for more information on our services and how we can help you ensure the safety and quality of your products.

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