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usp-1226-verification-of-compendial-procedures-for-impurity-detection
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 <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 USP <1226>: Verification of Compendial Procedures for Impurity Detection Laboratory Testing Service

Provided by Eurolab

USP <1226> is a compendial procedure that outlines the requirements for verifying laboratory testing procedures for impurity detection. The standard provides guidelines for ensuring the accuracy and reliability of laboratory test results, which is essential for maintaining product quality and safety.

The relevant standards governing USP <1226> include:

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

  • ASTM E1350-14 (Standard Practice for Conducting Tests on Chemicals or Materials Using Laboratory Testing Facilities)

  • EN ISO/IEC 17025:2005 (General requirements for the competence of testing and calibration laboratories)

  • TSE LDT 101 (Turkish Standard for Laboratory Accreditation)

  • USP <1226> (Verification of Compendial Procedures for Impurity Detection)

    • These standards emphasize the importance of laboratory accreditation, calibration, and validation to ensure that test results are reliable and accurate. Compliance with these standards is mandatory for laboratories providing testing services.

    Standard development organizations play a crucial role in shaping industry standards. Some notable organizations include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Standards evolve over time to reflect advancements in technology, changes in regulatory requirements, or new research findings. Laboratories must stay up-to-date with the latest standards and revisions.

    Relevant standard numbers and their scope are:

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

    • Scope: Provides guidelines for laboratory accreditation, calibration, and validation

  • ASTM E1350-14 - Standard Practice for Conducting Tests on Chemicals or Materials Using Laboratory Testing Facilities

    • Scope: Outlines procedures for conducting tests on chemicals or materials using laboratory facilities

  • EN ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories

    • Scope: Provides guidelines for laboratory accreditation, calibration, and validation

    Standard compliance is essential for industries such as:

  • Pharmaceuticals

  • Food and Beverage

  • Cosmetics

  • Chemicals

  • Environmental Monitoring

    • Non-compliance with standards can lead to costly recalls, reputational damage, and even regulatory penalties.

    The need for USP <1226> verification arises from the requirement for laboratories to demonstrate competence in testing procedures. The business and technical reasons for conducting this test include:

  • Ensuring accuracy and reliability of laboratory test results

  • Maintaining compliance with regulatory requirements

  • Demonstrating quality assurance and control (QA/QC) capabilities

  • Building customer confidence and trust

  • Enhancing product safety and reliability

    • Consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Inaccurate or unreliable laboratory test results

  • Damage to reputation and brand image

  • Financial losses due to recalls, litigation, or regulatory penalties

    • The industries that require USP <1226> verification are:

  • Pharmaceuticals (USP <1226> is a compendial procedure for the pharmaceutical industry)

  • Food and Beverage (compliance with regulations such as FDA 21 CFR Part 111)

  • Cosmetics (compliance with regulations such as EU Cosmetic Regulation No. 1223/2009)

    • Risk factors and safety implications include:

  • Non-compliance with standards can lead to product contamination or adulteration

  • Inaccurate laboratory test results can result in false labeling or marketing claims

    • The quality assurance and quality control aspects of USP <1226> verification include:

  • Ensuring accuracy and reliability of laboratory test results

  • Maintaining calibration and validation procedures

  • Demonstrating competence in testing procedures

  • Enhancing product safety and reliability

    • This test contributes to product safety and reliability by ensuring that laboratories are competent in testing procedures.

    Competitive advantages of having this testing performed include:

  • Enhanced customer confidence and trust

  • Improved brand image and reputation

  • Compliance with regulatory requirements

  • Reduced risk of non-compliance or regulatory penalties

    • The cost-benefit analysis of performing this test includes:

  • Cost savings due to reduced risk of non-compliance or regulatory penalties

  • Enhanced product safety and reliability

  • Increased customer confidence and trust

    • The USP <1226> verification involves several steps, including:

    1. Sample preparation: Preparation of the sample for analysis

    2. Testing equipment and instruments: Use of calibrated and validated testing equipment and instruments

    3. Testing environment requirements: Maintenance of controlled temperature, humidity, and pressure conditions

    4. Measurement and analysis methods: Use of established measurement and analysis methods

    5. Calibration and validation procedures: Regular calibration and validation of testing equipment and instruments

    The USP <1226> verification procedure includes:

  • Pre-verification review: Review of laboratory procedures and documentation to ensure compliance with standards

  • On-site audit: Inspection of laboratory facilities, equipment, and personnel to assess competence in testing procedures

  • Testing: Conducting tests on the sample using calibrated and validated equipment and instruments

  • Data analysis: Analysis of test data to determine accuracy and reliability

    • The USP <1226> verification process involves several key steps:

    1. Sample preparation: Preparation of the sample for analysis

    2. Equipment calibration: Calibration of testing equipment and instruments

    3. Testing: Conducting tests on the sample using calibrated and validated equipment and instruments

    4. Data analysis: Analysis of test data to determine accuracy and reliability

    5. Reporting: Issuance of a report detailing the results of the verification

    The reporting requirements for USP <1226> verification include:

  • A written report summarizing the results of the verification

  • Documentation of the laboratorys procedures and policies related to testing and analysis

  • Calibration and validation records for all equipment used in the testing process

  • Test data and results, including any corrections or adjustments made during analysis

    • The USP <1226> verification report should include:

  • Summary of the laboratorys procedures and policies related to testing and analysis

  • Description of the testing equipment and instruments used

  • Results of the calibration and validation procedures

  • Analysis of test data to determine accuracy and reliability

    • Conclusion

    USP <1226> is a compendial procedure that outlines the requirements for verifying laboratory testing procedures for impurity detection. The standard emphasizes the importance of ensuring accuracy and reliability of laboratory test results, which is essential for maintaining product quality and safety.

    The USP <1226> verification involves several steps, including sample preparation, testing equipment and instruments, testing environment requirements, measurement and analysis methods, calibration and validation procedures, pre-verification review, on-site audit, testing, data analysis, and reporting.

    Compliance with the standards governing USP <1226> is mandatory for laboratories providing testing services. The industries that require USP <1226> verification are pharmaceuticals, food and beverage, cosmetics, chemicals, and environmental monitoring.

    The risk factors and safety implications of non-compliance with standards include product contamination or adulteration, inaccurate laboratory test results, and false labeling or marketing claims.

    In conclusion, USP <1226> verification is essential for maintaining compliance with regulatory requirements, ensuring accuracy and reliability of laboratory test results, and enhancing product safety and reliability.

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