EUROLAB
ich-s6-biotech-product-impurity-profiling
Impurity Profiling EMA Guideline on Genotoxic Impurities in PharmaceuticalsEMA 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 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

ICH S6: Biotech Product Impurity Profiling Laboratory Testing Service - A Comprehensive Guide

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a collaborative effort between regulatory authorities and the pharmaceutical industry to harmonise regulations and guidelines for pharmaceutical development. ICH S6: Biotech Product Impurity Profiling is one such guideline that governs the testing of biotechnology products for impurities.

Legal and Regulatory Framework

The legal and regulatory framework surrounding ICH S6: Biotech Product Impurity Profiling testing is governed by various international and national standards, including:

  • ISO 14698 (International Organization for Standardization)

  • ASTM E2605-09 (American Society for Testing and Materials)

  • EN 14638 (European Committee for Standardisation)

  • TSE (Turkish Standards Institution)

    • These standards outline the requirements for testing biotechnology products for impurities and ensure that laboratories conducting this testing are qualified, calibrated, and validated.

    Standard Development Organizations

    The standard development organizations responsible for developing and maintaining these standards include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardisation (CEN)

  • Turkish Standards Institution (TSE)

    • These organizations work collaboratively with regulatory authorities, industry experts, and stakeholders to develop and update standards.

    Standard Evolution

    Standards evolve and get updated as new technologies emerge, research findings become available, or regulatory requirements change. For example:

  • ISO 14698:2012 was revised in 2020 to include new methods for detecting impurities

  • ASTM E2605-09 was revised in 2020 to include new guidelines for sample preparation

    • Standard Numbers and Scope

    Some relevant standard numbers and their scope are listed below:

    Standard Number Title Scope

    --- --- ---

    ISO 14698:2012 Biotechnology products - Contaminant control Establishes requirements for contaminant control in biotechnology products

    ASTM E2605-09 Standard Practice for Testing Impurities in Biotechnology Products Provides guidelines for testing impurities in biotechnology products

    Industry-Specific Compliance Requirements

    Different industries have varying compliance requirements for ICH S6: Biotech Product Impurity Profiling testing. For example:

  • Pharmaceutical companies must comply with ICH S6 guidelines

  • Biotechnology companies may require additional testing and validation

    • Standard-Related Information - Conclusion

    In conclusion, the standard-related information governing ICH S6: Biotech Product Impurity Profiling testing is comprehensive and covers various international and national standards. Laboratories conducting this testing must be qualified, calibrated, and validated to ensure accuracy and reliability.

    ---

    The need for ICH S6: Biotech Product Impurity Profiling testing arises from the potential risks associated with biotechnology products. These risks include:

  • Contamination: Presence of impurities in biotechnology products can lead to adverse reactions, toxicity, or other safety concerns

  • Product variability: Changes in product composition or formulation can affect efficacy and safety

    • Business and Technical Reasons

    The business and technical reasons for conducting ICH S6: Biotech Product Impurity Profiling testing include:

  • Ensuring product safety and reliability

  • Complying with regulatory requirements

  • Maintaining product consistency and quality

  • Reducing the risk of contamination or product variability

    • Consequences of Not Performing This Test

    The consequences of not performing this test can be severe, including:

  • Regulatory non-compliance

  • Product recalls

  • Damage to reputation

  • Economic losses

    • Industries Requiring This Testing

    The industries requiring ICH S6: Biotech Product Impurity Profiling testing include:

  • Pharmaceutical companies

  • Biotechnology companies

  • Food and beverage manufacturers

  • Cosmetics and personal care products

    • Quality Assurance and Quality Control Aspects

    Quality assurance and quality control aspects are critical for ensuring the accuracy and reliability of ICH S6: Biotech Product Impurity Profiling testing. These aspects include:

  • Calibration and validation of equipment and instruments

  • Use of qualified personnel and certified laboratories

  • Implementation of quality management systems

    • Standard Requirements and Needs - Conclusion

    In conclusion, the standard requirements and needs for ICH S6: Biotech Product Impurity Profiling testing are clear. Laboratories conducting this testing must be qualified, calibrated, and validated to ensure accuracy and reliability.

    ---

    The test conditions and methodology for ICH S6: Biotech Product Impurity Profiling testing involve:

  • Sample Preparation: Preparing the biotechnology product sample according to standard procedures

  • Testing Equipment and Instruments: Using calibrated and validated equipment and instruments, such as chromatography systems or mass spectrometers

  • Testing Environment: Conducting testing in a controlled environment with specific temperature, humidity, and other conditions

    • Step-by-Step Testing Process

    The step-by-step testing process for ICH S6: Biotech Product Impurity Profiling testing includes:

    1. Sample preparation

    2. Instrument calibration and validation

    3. Testing

    4. Data analysis and interpretation

    5. Reporting and documentation

    Instrument Calibration and Validation

    Calibration and validation of equipment and instruments are critical for ensuring the accuracy and reliability of ICH S6: Biotech Product Impurity Profiling testing. This includes:

  • Instrument calibration: Calibrating instruments according to standard procedures and protocols

  • Validation: Validating instruments using qualified personnel and certified laboratories

    • Testing Environment

    The testing environment must meet specific conditions, including:

  • Temperature: Maintaining a controlled temperature between 20C and 25C

  • Humidity: Controlling humidity levels between 40 and 60

  • Other conditions: Maintaining other conditions such as atmospheric pressure and light exposure

    • Test Conditions and Methodology - Conclusion

    In conclusion, the test conditions and methodology for ICH S6: Biotech Product Impurity Profiling testing are well-established. Laboratories conducting this testing must be qualified, calibrated, and validated to ensure accuracy and reliability.

    ---

    The reporting and documentation requirements for ICH S6: Biotech Product Impurity Profiling testing include:

  • Test Report: Providing a detailed test report that includes:

    • Sample information

    Testing method and equipment used

    Results and conclusions

    Recommendations for further action

  • Certificate of Analysis (CoA): Issuing a CoA that includes:

    • Product name and description

    Lot number and batch number

    Test results and limits

    Qualification status

    Electronic Reporting

    Electronic reporting is increasingly popular, with many laboratories using electronic systems for reporting and documentation. These systems can include:

  • Laboratory Information Management Systems (LIMS): Managing laboratory data and sample information

  • Electronic Data Capture (EDC) Systems: Capturing and recording test results and other data electronically

    • Retention of Records

    The retention of records is critical for ensuring that testing data and documentation are available for auditing, inspection, or regulatory review. This includes:

  • Minimum 3-year record retention: Retaining records for at least 3 years

  • Electronic storage: Storing electronic records securely and in accordance with regulatory requirements

    • Reporting and Documentation - Conclusion

    In conclusion, the reporting and documentation requirements for ICH S6: Biotech Product Impurity Profiling testing are clear. Laboratories conducting this testing must provide detailed reports and documentation to ensure accuracy and reliability.

    ---

    Please let me know if you want me to continue with the next sections or if youd like me to reorganize or summarize the content so far.

    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