EUROLAB
fda-guidance-threshold-of-toxicological-concern-ttc-for-impurities
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA ICH M3(R2): Impurities in Safety StudiesFDA Q&A on Impurities in Generic Drug ApplicationsFDA Q&A: Managing Impurities in Complex APIsICH E14: QT Interval Evaluation and Impurity ImpactICH M7: Mutagenic Impurity Risk AssessmentICH Q10: Pharmaceutical Quality System for Impurity ManagementICH Q11: Impurity Control Strategy in Drug Substance DevelopmentICH Q12: Lifecycle Management of Impurity Control StrategyICH Q1E: Evaluation of Stability Data Related to Impurity FormationICH Q2(R1): Validation of Analytical Methods for Impurity TestingICH Q3A: Organic Impurity Profiling in Drug SubstancesICH Q3B: Impurity Testing in Finished Drug ProductsICH Q3C: Residual Solvent ProfilingICH Q3D: Elemental Impurity Risk AssessmentICH Q3F: Impurity Guidelines for Biotechnology ProductsICH Q4B: Harmonization of Analytical Procedures for Impurity TestingICH Q5C: Impurity Monitoring in Biotechnological ProductsICH Q6A: Specifications and Acceptance Criteria for ImpuritiesICH S3A: Impurities Arising from Degradation ProductsICH S6: Biotech Product Impurity ProfilingICH S7A: Safety Pharmacology Impurity EvaluationICH S9: Impurities in Oncology ProductsISO 10993-18: Chemical Characterization and Impurity AnalysisISO 17025: Accreditation for Impurity Testing LaboratoriesJP General Rule 2.60: Limit Test for ImpuritiesPh. Eur. 2.2.28: Gas Chromatography for Impurity DetectionPh. Eur. 2.2.38: Thin-Layer Chromatography for ImpuritiesPh. Eur. 2.2.46: Chromatographic Separation for Impurity AnalysisPh. Eur. 2.4.14: Determination of Inorganic ImpuritiesPh. Eur. 2.4.20: Limit Test for Heavy Metals in ImpuritiesPh. Eur. 2.4.24: Related Substances by HPLC in APIsPh. Eur. 2.4.29: Limit Test for Sulfated Ash ImpuritiesPh. Eur. 2.5.13: Oxidizing Impurity TestsPh. Eur. 2.9.40: Uniformity of Dosage Units and Related ImpuritiesPh. Eur. 5.10: Control of Impurities in Substances for Pharmaceutical UsePh. Eur. 5.4: Impurities in Radiopharmaceutical PreparationsUSP <1010>: Analytical Data Integrity in Impurity ReportingUSP <1031>: The Biocompatibility of Materials and ImpuritiesUSP <1051>: Cleaning Validation Limits and Residual ImpuritiesUSP <1058>: Analytical Instrument Qualification for Impurity StudiesUSP <1078>: Good Manufacturing Practices for Impurity ReductionUSP <1085>: Evaluation of Impurity Method PerformanceUSP <1086>: Impurities in Drug SubstancesUSP <1088>: Forced Degradation Studies for Impurity CharacterizationUSP <1091>: Impurity Isolation and Characterization TechniquesUSP <1099>: Acceptable Analytical Performance CriteriaUSP <1121>: Bulk Pharmaceutical Chemicals and Impurity HandlingUSP <1151>: Pharmaceutical Dosage Forms and Impurity ConsiderationUSP <1191>: Stability Testing of Compounded PreparationsUSP <1222>: Terminal Sterilization Impact on ImpuritiesUSP <1224>: Transfer of Impurity Test ProceduresUSP <1225>: Validation of Compendial Procedures for ImpuritiesUSP <1226>: Verification of Compendial Procedures for Impurity DetectionUSP <1231>: Water for Pharmaceutical Purposes and Impurity EffectsUSP <1232>: Water Activity and Impurity StabilityUSP <1241>: Capsules and Shell Impurity InteractionUSP <1251>: Weighing on Analytical Balances for Micro-ImpuritiesUSP <161>: Transdermal Delivery Systems and Impurity ControlUSP <197>: Spectrophotometric Identification of ImpuritiesUSP <233>: Elemental Impurities Profiling Using ICP-MSUSP <41>: Balances Used for Impurity Weight DeterminationUSP <466>: Identification and Quantification of DegradantsUSP <467>: Residual Solvent Testing in APIs and ExcipientsUSP <476>: Impurity Profiling for New Drug ApplicationsUSP <621>: Chromatography Conditions for Impurity IdentificationUSP <730>: Plasma Spectrochemistry for Impurity ProfilingUSP <791>: pH Determination Impact on Impurity SolubilityUSP <797>: Sterile Compounding and Impurity ControlUSP <800>: Hazardous Drug Handling Based on Impurity RiskUSP <851>: Spectrophotometry and Light Scattering for ImpuritiesUSP <853>: Atomic Absorption Spectroscopy for Trace ImpuritiesUSP <857>: UV-Vis Spectroscopy for Impurity QuantificationUSP <85>: Bacterial Endotoxin Limits Related to Impurity SafetyUSP <891>: Nuclear Magnetic Resonance (NMR) for Structural ElucidationUSP <905>: Content Uniformity Related to ImpuritiesUSP <905>: Uniformity of Dosage Units Affected by ImpuritiesUSP <941>: Characterization of Impurity Solubility and pKaWHO TRS 970 Annex 2: Impurity Control in Medicines

Comprehensive Guide to FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities Laboratory Testing Service by Eurolab

Standard-Related Information

The FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing service provided by Eurolab is governed by a range of international and national standards. These standards ensure that the testing process meets the required quality, accuracy, and safety specifications.

International Standards

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

  • ASTM E55-08(2013) - Standard Practice for Sampling of Industrial Process Materials for Determination of Impurities

  • EN 14212:2008 - Chemical analysis - Determination of impurities in chemicals

    • National Standards

  • USP <233> - Elemental Impurities, and Limits

  • ICH Q3A(R2): Impurities: Guideline for Residuals and Impurities

  • EU GMP Annex 11: Computerized Systems, Data Management and Records

    • Standard Development Organizations

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • How Standards Evolve and Get Updated

    Standards are regularly reviewed and updated to reflect the latest scientific knowledge and technological advancements. This ensures that testing services like those provided by Eurolab remain current and compliant with regulatory requirements.

    Standard Numbers and Scope

  • ISO 17025:2017 - General requirements for the competence of testing and calibration laboratories

    • Applies to all types of laboratories, including chemical testing laboratories

    Covers aspects such as sampling, testing, reporting, and record-keeping

  • ASTM E55-08(2013) - Standard Practice for Sampling of Industrial Process Materials for Determination of Impurities

    • Focuses on the selection of representative samples from industrial process materials

    Outlines procedures for sample collection, preparation, and analysis

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for laboratories providing FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing services. This includes:

  • Maintaining a quality management system that meets ISO 9001 requirements

  • Ensuring personnel are properly trained and certified to perform testing tasks

  • Verifying the accuracy and reliability of testing equipment and instruments

    • Standards also play a crucial role in ensuring compliance with industry-specific regulations. For example:

  • The US FDA requires laboratories to comply with Good Laboratory Practice (GLP) guidelines, as outlined in 21 CFR Part 58

  • The European Medicines Agency (EMA) requires compliance with the ICH Q3A(R2): Impurities: Guideline for Residuals and Impurities

    • Standard-Related Information (Conclusion)

    Standards provide a framework for laboratories to ensure the quality, accuracy, and safety of their testing services. Compliance with relevant standards is essential for maintaining regulatory approvals and ensuring customer confidence.

    Standard Requirements and Needs

    The FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing service provided by Eurolab meets stringent standard requirements, including:

  • Compliance with ISO 17025:2017

  • Adherence to ASTM E55-08(2013)

  • Alignment with EU GMP Annex 11

    • This comprehensive guide will cover the specific needs and requirements of this testing service, including:

    Business and Technical Reasons for Conducting Testing

    The primary reasons for conducting FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing include:

    1. Compliance with regulatory requirements

    2. Ensuring product safety and reliability

    3. Reducing the risk of impurity-related liabilities

    Consequences of Not Performing Testing

    Failure to perform this test can result in:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Loss of customer confidence and reputation damage

    • Industries and Sectors Requiring Testing

    This testing service is essential for various industries, including:

    1. Pharmaceuticals

    2. Biotechnology

    3. Food and beverages

    4. Cosmetics and personal care products

    The risk factors associated with impurities in these products can have severe consequences, including adverse health effects, environmental damage, or economic losses.

    Quality Assurance and Quality Control Aspects

    Eurolabs quality management system ensures that all testing services meet the required standards for:

  • Sampling

  • Testing

  • Reporting

  • Record-keeping

    • This comprehensive guide will also cover the importance of quality assurance and control in maintaining customer confidence and regulatory compliance.

    Competitive Advantages and Market Positioning

    By providing FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing services, Eurolab can:

  • Enhance its market position

  • Increase customer trust and loyalty

  • Distinguish itself from competitors

    • This guide will also explore the benefits of outsourcing this testing service to a reputable laboratory like Eurolab.

    Standard Requirements and Needs (Conclusion)

    The FDA Guidance: Threshold of Toxicological Concern (TTC) for Impurities testing service provided by Eurolab meets stringent standard requirements, including compliance with ISO 17025:2017, ASTM E55-08(2013), and EU GMP Annex 11. This comprehensive guide will cover the specific needs and requirements of this testing service.

    Please let me know if you would like me to continue with the next section or make any changes to this comprehensive guide.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers