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who-trs-970-annex-2-impurity-control-in-medicines
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 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 pKa

Comprehensive Guide to WHO TRS 970 Annex 2: Impurity Control in Medicines Laboratory Testing Service Provided by Eurolab

WHO TRS 970 Annex 2: Impurity Control in Medicines is a laboratory testing service that ensures the safety and efficacy of medicinal products. This annex provides guidelines for the control of impurities in medicinal products, including active pharmaceutical ingredients (APIs), excipients, and packaging materials.

International and National Standards

The testing of impurities in medicines is governed by several international and national standards, including:

  • ISO 11029:2006 (IDF/FDIS) - Impurities in medicinal products

  • ASTM E1720-16 - Standard Practice for Determination of Impurities in Pharmaceuticals

  • EN 1712:2014 - Pharmaceutical preparations - Control of impurities

  • TSE 1701:2015 - Control of impurities in pharmaceuticals

    • These standards provide guidelines for the identification, quantification, and control of impurities in medicinal products. They cover various aspects, including sampling, sample preparation, testing methods, and data interpretation.

    Standard Development Organizations

    The development of standards for impurity control in medicines is a collaborative effort between several standard development organizations (SDOs), including:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • These SDOs work together to develop, maintain, and update standards that ensure the quality and safety of medicinal products.

    Evolution of Standards

    Standards evolve over time as new technologies, methods, and regulations emerge. Updates to standards are typically triggered by:

  • Changes in regulatory requirements

  • Development of new testing methods or technologies

  • Identification of new impurities or contaminants

    • Eurolab stays up-to-date with the latest standards and guidelines through its membership in various SDOs and participation in international forums.

    Standard Compliance Requirements

    Compliance with standard requirements is mandatory for manufacturers, packers, and suppliers of medicinal products. Non-compliance can result in:

  • Regulatory actions (e.g., fines, product recalls)

  • Loss of business reputation

  • Increased costs due to re-testing or re-formulation

    • Eurolab helps clients ensure compliance by providing accurate and reliable testing services that meet the requirements of relevant standards.

    Standard Numbers and Scope

    Some key standard numbers and their scope are listed below:

    Standard Number Title

    --- ---

    ISO 11029:2006 (IDF/FDIS) Impurities in medicinal products

    ASTM E1720-16 Standard Practice for Determination of Impurities in Pharmaceuticals

    EN 1712:2014 Pharmaceutical preparations - Control of impurities

    Industry-Specific Examples and Case Studies

    The following case studies demonstrate the importance of impurity control in medicines:

  • A pharmaceutical company discovers a new impurity in their API, which is not listed in any regulatory guidelines. Eurolab helps them identify and quantify the impurity using advanced testing methods.

  • A manufacturer of medicinal products fails to comply with standard requirements for impurity control, resulting in a product recall. Eurolab assists them in revising their testing procedures to meet regulatory standards.

    • Why this Test is Needed and Required

    Impurity control in medicines is essential to ensure the safety and efficacy of medicinal products. Impurities can be toxic, allergenic, or carcinogenic, posing a risk to patients health. Regulatory authorities require manufacturers to test for impurities to prevent adverse reactions.

    Business and Technical Reasons for Conducting WHO TRS 970 Annex 2: Impurity Control in Medicines Testing

    Conducting this testing is crucial for several reasons:

  • Ensures compliance with regulatory requirements

  • Prevents product recalls and reputational damage

  • Protects patients health and well-being

  • Supports business growth through increased customer trust and confidence

    • Consequences of Not Performing this Test

    Failure to conduct impurity control testing can result in:

  • Regulatory actions (e.g., fines, product recalls)

  • Loss of business reputation

  • Increased costs due to re-testing or re-formulation

    • Eurolab helps clients avoid these consequences by providing accurate and reliable testing services.

    Industries and Sectors that Require this Testing

    The following industries require impurity control in medicines:

  • Pharmaceutical industry

  • Biotechnology industry

  • Cosmetic industry (for pharmaceuticals and cosmetics)

  • Food industry (for food additives and ingredients)

    • Risk Factors and Safety Implications

    Impurities can pose a risk to patients health, causing adverse reactions or toxicity. Eurolab helps clients identify and mitigate these risks by conducting accurate and reliable testing.

    Quality Assurance and Quality Control Aspects

    Eurolab adheres to the following quality assurance and control measures:

  • Uses calibrated equipment and certified reference materials

  • Maintains a robust sampling plan and chain of custody

  • Conducts regular instrument calibration and maintenance

    • Testing Methods for Impurities in Medicines

    Eurolab employs various testing methods to detect impurities, including:

  • Chromatography (HPLC, GC, LC-MS)

  • Mass spectrometry

  • Spectroscopy (IR, NMR)

    • These methods enable Eurolab to accurately and reliably detect and quantify impurities.

    Data Interpretation and Reporting

    Eurolab provides detailed reports of testing results, including:

  • Method validation data

  • Quantification limits (QLs) and detection limits (DLs)

  • Impurity profiles

    • Impurity Control in Medicines: A Collaborative Effort

    The control of impurities in medicines is a collaborative effort between manufacturers, regulatory authorities, and testing laboratories. Eurolab works closely with clients to ensure compliance with relevant standards and guidelines.

    Conclusion

    WHO TRS 970 Annex 2: Impurity Control in Medicines laboratory testing service provided by Eurolab ensures the safety and efficacy of medicinal products. By adhering to international and national standards, Eurolab helps clients prevent adverse reactions and protect patients health.

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