EUROLAB
usp-1117-best-practices-for-handling-hazardous-compounds
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 <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 <1117> Best Practices for Handling Hazardous Compounds Laboratory Testing Service: A Comprehensive Guide

The USP <1117> Best Practices for Handling Hazardous Compounds testing service is governed by various international and national standards. The primary standard governing this testing service is the United States Pharmacopeia (USP) <1117> Best Practices for Handling Hazardous Compounds. This standard outlines the guidelines for handling hazardous compounds in a laboratory setting, including procedures for labeling, storage, and disposal.

International Standards:

  • ISO 11000:2006(E) - Hazard identification, risk assessment, and hazard control
  • ASTM E1403-08 - Standard Practice for Sampling of Materials for Determination of Chemical Content
  • EN 14404-1:2014 - Laboratory testing equipment - Part 1: Requirements for safety-related laboratory testing equipment
  • National Standards:

  • USP <1117> Best Practices for Handling Hazardous Compounds
  • OSHA 29 CFR 1910.1450 - Occupational Exposure to Hazardous Chemicals in Laboratories
  • EPA 40 CFR 261-270 - Hazardous Waste Management Regulations
  • Standard Development Organizations and Their Role:

    The standard development organizations involved in the creation of standards for USP <1117> Best Practices for Handling Hazardous Compounds testing include:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • United States Pharmacopeia (USP)
  • Standard Evolution and Updates:

    Standards evolve and get updated as new research emerges or regulatory requirements change. This ensures that testing services like USP <1117> Best Practices for Handling Hazardous Compounds remain current and compliant with evolving regulations.

    Specific Standard Numbers and Scope:

    The following standard numbers are relevant to this testing service:

  • USP <1117>: Best Practices for Handling Hazardous Compounds
  • ISO 11000:2006(E): Hazard identification, risk assessment, and hazard control
  • These standards outline the procedures and requirements for handling hazardous compounds in a laboratory setting.

    Standard Compliance Requirements for Different Industries:

    Compliance with these standards is essential for various industries, including:

  • Pharmaceutical industry: USP <1117> Best Practices for Handling Hazardous Compounds
  • Chemical manufacturing industry: ISO 11000:2006(E)
  • Laboratory testing industry: ASTM E1403-08
  • These industries must adhere to specific standards and guidelines to ensure the safe handling of hazardous compounds.

    Why This Specific Test is Needed and Required

    The USP <1117> Best Practices for Handling Hazardous Compounds testing service is necessary due to the risks associated with handling hazardous compounds. These substances can cause harm if not handled properly, resulting in accidents, injuries, and environmental contamination.

    Business and Technical Reasons for Conducting This Testing:

    Conducting this testing ensures:

  • Compliance with regulatory requirements
  • Protection of personnel, equipment, and the environment from hazardous compounds
  • Maintenance of product quality and safety
  • Prevention of accidents and injuries
  • Consequences of Not Performing This Test

    Failure to conduct this testing may result in:

  • Non-compliance with regulatory requirements
  • Accidents, injuries, or environmental contamination due to improper handling of hazardous compounds
  • Decreased product quality and safety
  • Loss of customer trust and reputation
  • Industries and Sectors that Require This Testing:

    This testing is required for various industries and sectors, including:

  • Pharmaceutical industry
  • Chemical manufacturing industry
  • Laboratory testing industry
  • Risk Factors and Safety Implications:

    Handling hazardous compounds poses significant risks to personnel, equipment, and the environment. These risks can be mitigated through proper handling and testing procedures.

    Quality Assurance and Quality Control Aspects:

    This testing ensures compliance with quality assurance and quality control requirements, ensuring that products meet safety and performance standards.

    How This Test Contributes to Product Safety and Reliability:

    This testing contributes to product safety and reliability by:

  • Ensuring compliance with regulatory requirements
  • Maintaining product quality and safety
  • Preventing accidents and injuries
  • Competitive Advantages of Having This Testing Performed:

    Performing this testing provides a competitive advantage through:

  • Enhanced reputation and customer trust
  • Compliance with regulatory requirements
  • Improved product quality and safety
  • Cost-Benefit Analysis of Performing This Test

    The cost-benefit analysis of performing this test indicates that the benefits outweigh the costs, as it ensures compliance with regulatory requirements, maintains product quality and safety, and prevents accidents and injuries.

    Detailed Step-by-Step Explanation of How the Test is Conducted:

    The USP <1117> Best Practices for Handling Hazardous Compounds testing service involves:

    1. Sampling: Collecting representative samples of hazardous compounds

    2. Labeling: Labeling containers and equipment with proper warnings and instructions

    3. Storage: Storing hazardous compounds in designated areas, away from personnel and equipment

    4. Disposal: Disposing of hazardous compounds according to regulatory requirements

    Sampling Procedures:

    Sampling procedures involve:

    1. Selection of representative samples

    2. Collection of samples using appropriate equipment

    3. Handling and storage of samples

    Labeling Procedures:

    Labeling procedures involve:

    1. Labeling containers with proper warnings and instructions

    2. Labeling equipment with safety precautions and emergency contact information

    Storage Procedures:

    Storage procedures involve:

    1. Storing hazardous compounds in designated areas, away from personnel and equipment

    2. Maintaining accurate records of storage and handling activities

    Disposal Procedures:

    Disposal procedures involve:

    1. Disposing of hazardous compounds according to regulatory requirements

    2. Maintaining accurate records of disposal activities

    Testing Equipment and Supplies:

    The following testing equipment and supplies are used for this service:

  • Sampling equipment (e.g., pipettes, sample containers)
  • Labeling equipment (e.g., label printers, labeling machines)
  • Storage equipment (e.g., shelving, cabinets)
  • Disposal equipment (e.g., waste containers, disposal bags)
  • Testing Personnel:

    Personnel involved in this testing service must:

    1. Have proper training and certification

    2. Follow established procedures for sampling, labeling, storage, and disposal of hazardous compounds

    Quality Control and Assurance Measures:

    Quality control and assurance measures include:

    1. Regular monitoring of personnel and equipment performance

    2. Maintenance of accurate records of testing activities

    3. Implementation of corrective actions to address any deviations from standard operating procedures.

    Please note that the above is a general overview, and specific details may vary depending on your organizations needs and requirements.

    The next section will discuss Test Results and Reporting.

    Need help or have a question?
    Contact us for prompt assistance and solutions.

    Latest News

    View all

    JOIN US
    Want to make a difference?

    Careers