EUROLAB
usp-1226-verification-of-compendial-procedures
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1047> Testing for Biotechnological Protein ProductsUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1226> Verification of Compendial Procedures Laboratory Testing Service: A Comprehensive Guide

The USP <1226> Verification of Compendial Procedures testing service is governed by various international and national standards, including those from the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Electrotechnical Standardization (CENELEC), Turkish Standards Institution (TSE), and others. These standards ensure that laboratory tests are conducted in a consistent and reliable manner.

Legal and Regulatory Framework

The legal and regulatory framework surrounding USP <1226> Verification of Compendial Procedures testing is established by national laws, regulations, and international agreements. In the United States, for example, the Food and Drug Administration (FDA) regulates laboratory tests under the Federal Food, Drug, and Cosmetic Act.

International and National Standards

The following standards are relevant to USP <1226> Verification of Compendial Procedures testing:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories

  • ASTM E2500-13 Standard Practice for General Requirements for Validation of Analytical Methods

  • CENELEC EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories

  • TSE EN ISO/IEC 17025:2006 General requirements for the competence of testing and calibration laboratories

    • Standard Development Organizations

    Standard development organizations, such as ISO, ASTM, CENELEC, and TSE, play a crucial role in establishing and maintaining standards. These organizations ensure that standards are developed through a consensus-driven process involving experts from various fields.

    Evolution of Standards

    Standards evolve over time to reflect advances in technology, changes in regulatory requirements, or emerging industry needs. Updates to standards can be triggered by various factors, including:

  • New scientific research and findings

  • Changes in regulatory requirements

  • Emerging industry trends and best practices

    • Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

  • ISO 17025:2005 General requirements for the competence of testing and calibration laboratories (scope: general requirements for laboratory competence)

  • ASTM E2500-13 Standard Practice for General Requirements for Validation of Analytical Methods (scope: validation of analytical methods)

  • CENELEC EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories (scope: general requirements for laboratory competence)

    • Standard Compliance Requirements

    Compliance with standards is essential for laboratory tests to be credible, reliable, and trustworthy. Different industries have varying standard compliance requirements:

  • Pharmaceuticals: USP <1226> Verification of Compendial Procedures

  • Food: FDA 21 CFR Part 111

  • Cosmetics: ISO 17025:2005

    • Standard-Related Information Table

    Standard Number Title Scope

    --- --- ---

    ISO 17025:2005 General requirements for the competence of testing and calibration laboratories General requirements for laboratory competence

    ASTM E2500-13 Standard Practice for General Requirements for Validation of Analytical Methods Validation of analytical methods

    CENELEC EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories General requirements for laboratory competence

    The USP <1226> Verification of Compendial Procedures testing service is essential to ensure that pharmaceutical products meet regulatory requirements. This test verifies that compendial procedures are followed accurately and consistently.

    Business and Technical Reasons

    Conducting USP <1226> Verification of Compendial Procedures testing has several business and technical reasons:

  • Ensures compliance with regulatory requirements

  • Verifies accuracy and consistency of compendial procedures

  • Enhances product safety and reliability

  • Supports quality assurance and control

    • Consequences of Not Performing the Test

    Failure to conduct USP <1226> Verification of Compendial Procedures testing can lead to:

  • Regulatory non-compliance

  • Product recalls or withdrawals

  • Reputation damage

  • Loss of customer confidence

    • Industries and Sectors that Require this Testing

    The following industries and sectors require USP <1226> Verification of Compendial Procedures testing:

  • Pharmaceuticals

  • Food

  • Cosmetics

  • Biotechnology

    • Risk Factors and Safety Implications

    Conducting USP <1226> Verification of Compendial Procedures testing mitigates risks associated with:

  • Regulatory non-compliance

  • Product contamination or adulteration

  • Customer dissatisfaction

    • Quality Assurance and Control Aspects

    USP <1226> Verification of Compendial Procedures testing contributes to quality assurance and control by:

  • Verifying accuracy and consistency of compendial procedures

  • Ensuring compliance with regulatory requirements

  • Enhancing product safety and reliability

    • Competitive Advantages

    Conducting USP <1226> Verification of Compendial Procedures testing provides several competitive advantages, including:

  • Enhanced reputation and credibility

  • Increased customer confidence

  • Regulatory non-compliance avoidance

    • Standard Requirement and Needs Table

    Industry/Sector Regulatory Requirements Risk Factors and Safety Implications

    --- --- ---

    Pharmaceuticals USP <1226> Verification of Compendial Procedures Regulatory non-compliance, product contamination or adulteration

    Food FDA 21 CFR Part 111 Customer dissatisfaction, product recalls or withdrawals

    Standard-Related Information Table

    Standard Number Title Scope

    --- --- ---

    ISO 17025:2005 General requirements for the competence of testing and calibration laboratories General requirements for laboratory competence

    ASTM E2500-13 Standard Practice for General Requirements for Validation of Analytical Methods Validation of analytical methods

    CENELEC EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories General requirements for laboratory competence

    Standard Requirement and Needs Conclusion

    In conclusion, USP <1226> Verification of Compendial Procedures testing is essential to ensure that pharmaceutical products meet regulatory requirements. This test verifies accuracy and consistency of compendial procedures, ensuring compliance with regulatory requirements.

    ---

    The rest of the document will follow the same format as above, covering other topics such as:

  • Method Validation and Verification

  • Analytical Instrument Qualification (AIQ)

  • Quality Control and Assurance

  • Training and Competence

  • Accreditation and Certification

    • Please let me know if you would like me to continue with the next section.

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