EUROLAB
usp-800-hazardous-drugs-handling-validation
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 <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> 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 <800> Hazardous Drugs Handling Validation Testing Service: A Comprehensive Guide

The USP <800> Hazardous Drugs Handling Validation testing service is governed by various international and national standards, including ISO 17025, ASTM E2538, EN 14181, TSE 1337, and others. These standards ensure that the testing process meets the required quality and safety criteria.

Legal and Regulatory Framework

The USP <800> Hazardous Drugs Handling Validation testing service is regulated by various laws and regulations, including OSHAs Bloodborne Pathogens Standard (29 CFR 1910.1030), EPAs Toxic Substances Control Act (TSCA) Title I, and the USP Chapter <797> Pharmaceutical Compounding - Sterile Preparations.

International and National Standards

The following standards are applicable to the USP <800> Hazardous Drugs Handling Validation testing service:

  • ISO 17025: General Requirements for the Competence of Testing and Calibration Laboratories

  • ASTM E2538: Standard Practice for Preparation of Test Samples for Hazardous Drug Handling Validation

  • EN 14181: Laboratory Equipment - Ventilation Systems

  • TSE 1337: Pharmaceutical Preparations - Sterile Preparations

    • Standard Development Organizations

    The standard development organizations involved in the creation and maintenance of standards related to USP <800> Hazardous Drugs Handling Validation testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

  • Turkish Standards Institution (TSE)

    • Evolution and Updates

    Standards evolve over time, and it is essential to stay up-to-date with the latest revisions. The standard development organizations regularly review and update standards to reflect new technologies, methodologies, and best practices.

    Standard Numbers and Scope

    The following standard numbers and scopes are relevant to the USP <800> Hazardous Drugs Handling Validation testing service:

  • ISO 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories

  • ASTM E2538-15 - Standard Practice for Preparation of Test Samples for Hazardous Drug Handling Validation

  • EN 14181:2003 - Laboratory Equipment - Ventilation Systems

    • Compliance Requirements

    Different industries have varying compliance requirements for USP <800> Hazardous Drugs Handling Validation testing. For example:

  • Pharmaceutical industry: Compliance with USP <797> and OSHAs Bloodborne Pathogens Standard (29 CFR 1910.1030)

  • Healthcare industry: Compliance with USP <797> and OSHAs Bloodborne Pathogens Standard (29 CFR 1910.1030)

    • Standard-Related Information Conclusion

    The USP <800> Hazardous Drugs Handling Validation testing service is governed by various international and national standards, ensuring that the testing process meets the required quality and safety criteria.

    Why This Test Is Needed

    The USP <800> Hazardous Drugs Handling Validation testing service is essential for ensuring the safe handling of hazardous drugs in healthcare settings. The consequences of not performing this test can be severe, including:

  • Exposure to hazardous drugs

  • Risk of contamination and infection

  • Non-compliance with regulatory requirements

    • Business and Technical Reasons

    Conducting USP <800> Hazardous Drugs Handling Validation testing is necessary for several business and technical reasons:

  • Ensuring product safety and reliability

  • Meeting regulatory compliance requirements

  • Reducing the risk of exposure to hazardous drugs

  • Improving quality assurance and quality control processes

    • Industries and Sectors

    The following industries and sectors require USP <800> Hazardous Drugs Handling Validation testing:

  • Pharmaceutical industry

  • Healthcare industry

  • Research institutions

  • Academic institutions

    • Risk Factors and Safety Implications

    The risk factors associated with hazardous drug handling include:

  • Exposure to hazardous drugs

  • Risk of contamination and infection

  • Non-compliance with regulatory requirements

    • Quality Assurance and Quality Control

    Conducting USP <800> Hazardous Drugs Handling Validation testing ensures that quality assurance and quality control processes are in place, including:

  • Sampling and testing procedures

  • Laboratory equipment maintenance and calibration

  • Personnel training and certification

    • Product Safety and Reliability

    The USP <800> Hazardous Drugs Handling Validation testing service contributes to product safety and reliability by:

  • Ensuring the safe handling of hazardous drugs

  • Meeting regulatory compliance requirements

  • Reducing the risk of exposure to hazardous drugs

    • Competitive Advantages

    Conducting USP <800> Hazardous Drugs Handling Validation testing provides competitive advantages, including:

  • Improved quality assurance and quality control processes

  • Reduced risk of exposure to hazardous drugs

  • Compliance with regulatory requirements

    • Cost-Benefit Analysis

    The cost-benefit analysis of conducting USP <800> Hazardous Drugs Handling Validation testing includes:

  • Cost savings through improved efficiency and reduced risk of exposure to hazardous drugs

  • Improved product safety and reliability

  • Meeting regulatory compliance requirements

    • Standard Requirements and Needs Conclusion

    The USP <800> Hazardous Drugs Handling Validation testing service is essential for ensuring the safe handling of hazardous drugs in healthcare settings.

    USP <800> Hazardous Drugs Handling Validation Testing Service: A Comprehensive Guide

    Please see below for the next section of this guide:

    Insert Next Section

    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