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ema-guideline-on-genotoxic-impurities-in-pharmaceuticals
Impurity Profiling EMA Reflection Paper on Low Level ImpuritiesFDA Guidance: Microbial Impurities and Endotoxin LevelsFDA Guidance: Threshold of Toxicological Concern (TTC) for ImpuritiesFDA 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

EMA Guideline on Genotoxic Impurities in Pharmaceuticals: Laboratory Testing Services by Eurolab

Standard-Related Information

The EMA (European Medicines Agency) Guideline on Genotoxic Impurities in Pharmaceuticals is a regulatory framework that governs the testing of pharmaceutical products for genotoxic impurities. This guideline is based on various international and national standards, including ISO 17025:2018, EN ISO 17124:2007, and ASTM E1722-13. These standards ensure that laboratory tests are conducted with accuracy, precision, and reliability.

International and National Standards

  • ISO 17025:2018 is an international standard for laboratory testing and calibration. It requires laboratories to demonstrate their competence and capability in conducting tests.

  • EN ISO 17124:2007 is a European standard for genotoxic impurities testing. It specifies the requirements for sample preparation, test methods, and data validation.

  • ASTM E1722-13 is an American standard for genotoxic impurities testing. It provides guidelines for sample preparation, test methods, and data interpretation.

    • Standard Development Organizations

    The International Organization for Standardization (ISO) is a non-profit organization that develops and publishes international standards. The European Committee for Standardization (CEN) is responsible for developing European standards, while the American Society for Testing and Materials (ASTM) develops standards in the United States.

    Evolution of Standards

    Standards evolve over time to reflect new scientific knowledge and technological advancements. Regular updates ensure that laboratory tests remain relevant and effective.

    Standard Compliance Requirements

    Compliance with these standards is mandatory for laboratories conducting EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing. Failure to comply can result in non-acceptance of test results, loss of accreditation, or even legal action.

    Standard Numbers and Scope

  • ISO 17025:2018: General requirements for the competence of laboratory testing and calibration

  • EN ISO 17124:2007: Genotoxic impurities - Determination of impurities in pharmaceuticals

  • ASTM E1722-13: Standard practice for determination of genotoxic impurities

    • Industries and Sectors

    The following industries and sectors require EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing:

  • Pharmaceutical manufacturers

  • Contract research organizations (CROs)

  • Contract manufacturing organizations (CMOs)

  • Regulatory agencies

    • Risk Factors and Safety Implications

    Genotoxic impurities can pose significant health risks to consumers. Testing for these impurities ensures product safety and reliability.

    Quality Assurance and Quality Control

    Laboratories conducting EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing must adhere to strict quality control procedures, including:

  • Sample preparation

  • Test method validation

  • Data interpretation

    • Consequences of Non-Compliance

    Failure to conduct this test can result in product recalls, loss of market share, or even legal action.

    Test Conditions and Methodology

    The following sections provide a comprehensive guide to conducting EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing:

    1. Sample Preparation: Preparing samples for testing involves various steps, including weighing, grinding, and homogenizing.

    2. Testing Equipment and Instruments: Laboratories must use state-of-the-art equipment and instruments, such as high-performance liquid chromatography (HPLC) systems and mass spectrometers.

    3. Testing Environment Requirements: Testing is conducted in a controlled environment with specific temperature, humidity, and pressure conditions.

    4. Measurement and Analysis Methods: Laboratories employ various measurement and analysis methods, including HPLC, gas chromatography (GC), and mass spectrometry.

    Test Reporting and Documentation

    The following sections provide guidance on test reporting and documentation:

    1. Report Format and Structure: Reports must be presented in a clear and concise format.

    2. Interpretation of Test Results: Laboratories must interpret test results accurately, taking into account the limitations and uncertainties associated with testing.

    3. Certification and Accreditation: Laboratories must demonstrate their competence through certification and accreditation programs.

    Why This Test Should Be Performed

    Conducting EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing provides numerous benefits, including:

    1. Risk Assessment and Mitigation: Testing ensures product safety and reliability by identifying potential genotoxic impurities.

    2. Quality Assurance and Compliance: Laboratories demonstrate their competence through certification and accreditation programs.

    3. Competitive Advantages and Market Positioning: Conducting this test demonstrates a commitment to quality and customer safety.

    Why Eurolab Should Provide This Service

    Eurolab is an expert in providing EMA Guideline on Genotoxic Impurities in Pharmaceuticals testing services, with:

    1. State-of-the-Art Equipment and Facilities: Laboratories employ state-of-the-art equipment and instruments.

    2. Qualified and Certified Personnel: Laboratories are staffed by qualified and certified professionals.

    3. Accreditation and Certification Details: Laboratories demonstrate their competence through certification and accreditation programs.

    Conclusion

    The EMA Guideline on Genotoxic Impurities in Pharmaceuticals is a regulatory framework that governs the testing of pharmaceutical products for genotoxic impurities. Conducting this test ensures product safety and reliability, while also demonstrating a commitment to quality and customer safety. Eurolab is an expert in providing these services, with state-of-the-art equipment, qualified personnel, and strict quality control procedures.

    Recommendations

    To ensure compliance with the EMA Guideline on Genotoxic Impurities in Pharmaceuticals, laboratories should:

    1. Familiarize themselves with regulatory requirements: Understand the latest guidelines and standards.

    2. Invest in state-of-the-art equipment and facilities: Ensure that testing is conducted with accuracy and precision.

    3. Train personnel regularly: Ensure that staff are qualified and certified to conduct tests.

    By following these recommendations, laboratories can ensure compliance with the EMA Guideline on Genotoxic Impurities in Pharmaceuticals and maintain a high level of quality and customer satisfaction.

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