EUROLAB
usp-1058-analytical-instrument-qualification
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 <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 <1226> Verification of Compendial 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 <1058> Analytical Instrument Qualification: Eurolabs Laboratory Testing Service

Standard-Related Information

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the quality of pharmaceuticals, dietary supplements, and other healthcare products. USP <1058> Analytical Instrument Qualification is one such standard that outlines the requirements for qualifying analytical instruments used in the testing of pharmaceuticals and related substances.

ISO/IEC 17025:2017

USP <1058> is based on ISO/IEC 17025:2017, which is an international standard for laboratory testing and calibration. This standard requires laboratories to demonstrate their competence to perform specific tests and calibrations. Eurolabs USP <1058> Analytical Instrument Qualification service is designed to meet the requirements of this standard.

ASTM E1402-18

The American Society for Testing and Materials (ASTM) has published a standard, ASTM E1402-18, which provides guidelines for qualifying analytical instruments. This standard is also referenced in USP <1058> and is used by Eurolab to ensure that their testing services meet the required standards.

EN ISO/IEC 17025:2017

The European Committee for Standardization (CEN) has published a harmonized standard, EN ISO/IEC 17025:2017, which is identical to ISO/IEC 17025:2017. This standard is used in the European Union and other countries that have adopted the CEN standards.

TSE 1154-2:2009

The Turkish Standards Institution (TSE) has published a standard, TSE 1154-2:2009, which provides guidelines for qualifying analytical instruments. This standard is used in Turkey and may be referenced by Eurolabs clients who are based in this country.

Standard Development Organizations

Standards development organizations (SDOs) such as USP, ISO, ASTM, CEN, and TSE play a crucial role in establishing standards for laboratory testing and calibration. These SDOs bring together experts from industry, academia, and government to develop and maintain standards that are relevant to specific industries or sectors.

Evolution of Standards

Standards evolve over time as new technologies emerge, and existing ones become outdated. Eurolabs USP <1058> Analytical Instrument Qualification service is designed to meet the current requirements of these evolving standards.

Standard Numbers and Scope

USP <1058> has the following standard numbers and scope:

  • USP 1058: Analytical instrument qualification

    • Scope: This standard covers the procedures for qualifying analytical instruments used in pharmaceutical testing.

    Requirements:

    - Instrument calibration and validation

    - Performance testing

    - Qualification of new instruments

    - Requalification of existing instruments

    Standard Compliance Requirements

    Industry-specific requirements for USP <1058> compliance include:

  • Pharmaceutical industry: Comply with USP <1058> as a minimum requirement.

  • Biotechnology industry: Comply with USP <1058> and ISO/IEC 17025:2017 as a minimum requirement.

  • Food industry: Comply with ASTM E1402-18 and EN ISO/IEC 17025:2017 as a minimum requirement.

    • Consequences of Non-Compliance

    Failure to comply with USP <1058> may result in:

  • Product rejection or recall

  • Regulatory fines or penalties

  • Loss of reputation and customer confidence

    • Business and Technical Reasons for Conducting USP <1058> Testing

    The business and technical reasons for conducting USP <1058> testing include:

  • Ensuring product quality and safety

  • Meeting regulatory requirements

  • Maintaining product reliability and consistency

  • Reducing the risk of product recall or rejection

  • Improving customer confidence and trust

    • Quality Assurance and Quality Control Aspects

    USP <1058> requires laboratories to demonstrate their competence through a combination of quality assurance (QA) and quality control (QC) measures. These include:

  • Instrument calibration and validation

  • Performance testing

  • Qualification of new instruments

  • Requalification of existing instruments

    • Risk Assessment and Mitigation

    Conducting USP <1058> testing can help mitigate risks associated with product failure or rejection, regulatory fines or penalties, and loss of reputation and customer confidence.

    Cost-Benefit Analysis

    The cost-benefit analysis of conducting USP <1058> testing includes:

  • Reduced costs associated with product recall or rejection

  • Improved product quality and reliability

  • Increased customer confidence and trust

  • Regulatory compliance benefits

    • Test Conditions and Methodology

    The following are the test conditions and methodology for EUROLABs USP <1058> Analytical Instrument Qualification service:

    1. Instrument Calibration: Calibrate instruments according to the manufacturers instructions.

    2. Performance Testing: Conduct performance testing using a combination of calibration checks, precision, and accuracy tests.

    3. Qualification of New Instruments: Qualify new instruments before use in production or quality control.

    4. Requalification of Existing Instruments: Requalify existing instruments at regular intervals (e.g., every 12 months).

    Test Report

    Eurolabs USP <1058> Analytical Instrument Qualification service includes a comprehensive test report that includes:

  • Summary of the testing conducted

  • Results of the performance tests

  • Conclusion on whether the instrument meets the required standards

    • Conclusion

    USP <1058> Analytical Instrument Qualification is a critical standard for ensuring product quality and safety in pharmaceutical, biotechnology, food, and other industries. Eurolabs USP <1058> service is designed to meet these requirements, providing clients with a comprehensive and reliable testing solution.

    Please note that this is a general guide and not a substitute for consulting the relevant standards or seeking professional advice.

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