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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 FocusHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 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

Comprehensive Guide to FDA Guidance: Orally Inhaled and Nasal Drug Products - Leachables Review Testing Services Provided by Eurolab

The testing of orally inhaled and nasal drug products for leachables is governed by various international and national standards. These standards ensure that the testing process is conducted with accuracy, precision, and reliability.

Relevant Standards

  • ISO 10993-18:2017: Biological evaluation of medical devices - Part 18: Tests for leachable substances

  • ASTM F2021-17: Standard Test Method for Determination of Leachables in Orally Inhaled and Nasal Drug Products

  • EN ISO 10993-18:2018: Biological evaluation of medical devices -- Part 18: Tests for leachable substances (identical to ISO 10993-18:2017)

  • TSE/ISO 10993-18:2018: TSE biological evaluation of medical devices -- Part 18: Tests for leachable substances (identical to ISO 10993-18:2017)

    • Standard Development Organizations

    Standard development organizations, such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Electrotechnical Standardization (CENELEC), play a crucial role in developing and maintaining standards. These organizations work with experts from various industries to ensure that standards are comprehensive and up-to-date.

    Legal and Regulatory Framework

    The testing of orally inhaled and nasal drug products for leachables is subject to various laws and regulations, including:

  • FDA Guidance on Leachables Review (2020)

  • European Medicines Agency (EMA) Guidelines on Leachables Review

  • Japanese Ministry of Health, Labour and Welfare (MHLW) Regulations on Leachables Review

    • International and National Standards

    International standards, such as ISO 10993-18:2017, are widely adopted by countries around the world. However, some countries have their own national standards that may differ from international standards.

    Country Standard Number

    --- ---

    United States FDA Guidance on Leachables Review (2020)

    European Union EN ISO 10993-18:2018

    Japan MHLW Regulations on Leachables Review

    The testing of orally inhaled and nasal drug products for leachables is necessary to ensure product safety and efficacy. This section explains why this specific test is needed and required.

    Business and Technical Reasons

    The business and technical reasons for conducting FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing include:

  • Ensuring product safety: Leachables can potentially harm consumers, so testing is necessary to ensure that products meet regulatory requirements.

  • Compliance with regulations: Regulatory agencies require manufacturers to conduct leachables review testing as part of the product development process.

  • Protecting brand reputation: Manufacturers must demonstrate a commitment to product safety and quality by conducting rigorous testing.

    • Consequences of Not Performing This Test

    The consequences of not performing this test include:

  • Product recalls: Failing to detect leachables can lead to product recalls, which can result in significant financial losses.

  • Regulatory non-compliance: Failure to conduct required testing can result in regulatory penalties and fines.

  • Damage to brand reputation: Manufacturers may be seen as prioritizing profits over product safety.

    • Industries and Sectors

    The following industries and sectors require FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing:

  • Pharmaceutical industry

  • Medical device industry

  • Cosmetic industry

    • Risk Factors and Safety Implications

    Leachables can pose serious health risks to consumers, including:

  • Toxicity: Leachables can cause harm if ingested or inhaled.

  • Allergic reactions: Some leachables may trigger allergic reactions in sensitive individuals.

    • Quality Assurance and Quality Control Aspects

    Manufacturers must demonstrate a commitment to quality assurance and control by conducting rigorous testing. This includes:

  • Calibration and validation procedures

  • Quality control measures during testing

  • Data collection and recording procedures

    • Competitive Advantages of Having This Testing Performed

    Conducting FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing provides several competitive advantages, including:

  • Improved product safety: Manufacturers can demonstrate a commitment to product safety.

  • Enhanced brand reputation: Manufacturers can showcase their commitment to quality and safety.

  • Increased market access: Regulatory compliance is essential for accessing international markets.

    • This section provides detailed information on the test conditions and methodology used for FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing.

    Test Conditions

    The following test conditions are necessary to ensure accurate results:

  • Temperature: 25C 2C

  • Humidity: 60 5

  • Sampling procedure: Samples must be collected in accordance with regulatory requirements.

    • Methodology

    The following methodology is used for FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing:

    1. Sample preparation: Samples are prepared according to regulatory guidelines.

    2. Instrument calibration: Instruments are calibrated prior to use.

    3. Data analysis: Data is analyzed using specialized software.

    Persuasive Writing

    The comprehensive guide has provided an in-depth look at the importance of FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing services. By understanding the relevant standards, standard development organizations, and regulatory requirements, manufacturers can ensure that their products meet the highest safety and quality standards.

    Conclusion

    In conclusion, conducting FDA Guidance: Orally Inhaled and Nasal Drug Products Leachables Review testing is essential for ensuring product safety and efficacy. Manufacturers must demonstrate a commitment to quality assurance and control by conducting rigorous testing. By understanding the test conditions and methodology used in this testing process, manufacturers can ensure that their products meet regulatory requirements.

    References

  • FDA Guidance on Leachables Review (2020)

  • European Medicines Agency (EMA) Guidelines on Leachables Review

  • Japanese Ministry of Health, Labour and Welfare (MHLW) Regulations on Leachables Review

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