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iso-17034-reference-material-stability-and-homogeneity
Stability Studies (ICH Guidelines) BP Appendix XVI Stability of Finished Products with PreservativesBP Stability Evaluation of Modified Release PreparationsEMA CHMP/QWP/609/2014 Quality Requirements for Stability of BiosimilarsEMA CPMP/QWP/122/02 Stability Testing for Transdermal PatchesEMA Guideline for Stability of Veterinary Medicinal ProductsEMA Guideline on Holding Times for Bulk Products (Stability Implication)EMA Guideline on Stability Testing for Liposomal Drug FormulationsEMA Guideline on Stability Testing for Orally Inhaled ProductsEMA Reflection Paper on Stability for Polymers in Drug DeliveryEMA Reflection Paper on Stability of Advanced Therapies (ATMPs)EMA Stability Testing for Nanoparticle FormulationsEMA Stability Testing in Pediatric FormulationsEMA Stability Testing of Drug-Device Combination ProductsEP 1.2.1 Drug Substance Stability in Multisource SubmissionsEP 2.9.5 Uniformity of Mass Post-Stability TestingEP 3.2.1 Container Closure System Stability EvaluationEP 5.20 Climatic Conditions in Stability Storage ChambersEP 6.0 Stability Testing Requirements for MonographsEP 6.1 Real-Time Stability Testing of Biological ExtractsEP Climatic Zones IVa and IVb for ASEAN and African MarketsFDA 21 CFR 211.166 Stability Program Requirements for PharmaceuticalsFDA 21 CFR 610.17 Stability Testing of Biological ProductsFDA Accelerated Stability Protocol for Veterinary DrugsFDA cGMP Guidelines for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for Nutritional SupplementsFDA Guidance on Freeze-Thaw Stability Testing for BiologicsFDA Post-Approval Changes and Stability RequirementsFDA Q&A Guidance for Stability of Topical Dermatologic ProductsFDA Requirements for Drug Substance Holding Time & StabilityFDA Requirements for Orphan Drugs and Niche Stability StudiesICH E2E Pharmacovigilance & Stability Shelf-life ManagementICH E3 Stability Documentation in Clinical Study ReportsICH E6(R2) GCP Considerations in Clinical Trial Stability SamplesICH M10 Bioanalytical Method Validation in Stability TestingICH M4Q Stability Data Compilation for Common Technical Document (CTD)ICH M9 Stability of Biowaiver-Based Generic SubmissionsICH Q10 Pharmaceutical Quality System and Stability OversightICH Q11 Stability of Drug Substances in Developmental StagesICH Q12 Lifecycle Management and Ongoing Stability MonitoringICH Q14 Analytical Procedure Development in Stability StudiesICH Q1A(R2) Accelerated Stability Testing of Solid Oral Dosage FormsICH Q1B Photostability Testing for Light-Sensitive Drug ProductsICH Q1C Stability Testing for New Dosage Forms (Capsules, Tablets, etc.)ICH Q1D Bracketing and Matrixing Design Stability Protocol DevelopmentICH Q1E Evaluation of Stability Data for Regulatory SubmissionsICH Q1F Stability Data Requirements for Global RegistrationICH Q2(R1) Validation of Analytical Procedures in Stability StudiesICH Q3B(R2) Stability Testing of Impurities in Drug ProductsICH Q3C Residual Solvent Stability in Finished Dosage FormsICH Q4 Guidelines for Pharmacopoeial Stability HarmonizationICH Q4B Annex Stability-Related Harmonization for Global FilingICH Q5C Stability Testing of Biotechnological/Biological ProductsICH Q5D Derivation and Stability of Cell SubstratesICH Q6B Specifications Testing for Biotech Products in Long-Term StudiesICH Q8 Design Space for Stability-Critical ParametersICH Q9 Risk-Based Stability Planning and Protocol DesignICH S3B Photostability of Biologics in Animal StudiesICH S4 Stability of New Veterinary Drug Substances and ProductsICH S6(R1) Preclinical Stability of Biotech ProductsISO 10993-1 Biocompatibility Stability Studies in Medical DevicesISO 11607 Package Integrity Stability for Sterile Medical DevicesISO 13408 Stability Testing of Aseptic Processing SystemsISO 14644 Environmental Monitoring for Stability ChambersISO 14971 Risk Management Related to Stability FailuresISO 15378 GMP for Primary Packaging Stability InteractionsISO 17025 Stability Testing Accreditation RequirementsISO 20387 Stability Assessment in Biobanking Sample StorageISO 21973 Transport Stability of Cell-Based TherapiesISO 9001:2015 Quality System Requirements for Stability ProgramsUSP <1046> Cellular and Gene Therapy Product StabilityUSP <1049> Excipient Stability and Shelf-Life EvaluationUSP <1079> Storage and Stability Testing in Distribution SystemsUSP <1086> Impurities Testing within Stability ProtocolsUSP <1090> Assessment of Drug Product Performance Post StabilityUSP <1118> Monitoring Stability in Storage and Transport ConditionsUSP <1168> Stability Testing for RadiopharmaceuticalsUSP <1191> Stability Considerations in Compounding Pharmacy ProductsUSP <1224> Transfer of Analytical Procedures in Stability StudiesUSP <1225> Validation of Compendial Procedures in Stability ContextUSP <1226> Verification of Compendial Procedures Post-StabilityUSP <671> Stability Testing of Packaging MaterialsUSP <795> Stability Evaluation of Nonsterile PreparationsUSP <797> Stability Testing of Sterile Preparations in CleanroomsWHO Annex 10 Stability Testing of Active Pharmaceutical IngredientsWHO Annex 7 Stability of Reconstituted Lyophilized ProductsWHO Annex 9 Stability for Zoonotic Biological ProductsWHO Good Storage and Distribution Practices for StabilityWHO Guidelines for Stability of DNA and mRNA VaccinesWHO Guidelines on Stability of Combination ARV TherapiesWHO Stability of Monoclonal Antibodies Under Accelerated ConditionsWHO Stability Requirements for Medical Oxygen and InhalersWHO Stability Testing for Pre-Filled Syringes and Auto-InjectorsWHO Temperature Mapping and Qualification of Stability ChambersWHO TRS 1003 Stability Protocols for Combination ProductsWHO TRS 1010 Stability Testing for Vaccines under Cold Chain ConditionsWHO TRS 1019 Stability Testing of Blood and Blood ProductsWHO TRS 953 Climatic Zone-Based Stability Testing for Global MarketsWHO TRS 970 Real-Time Stability Assessment for WHO PrequalificationWHO TRS 992 Long-Term Stability Testing for Herbal Medicinal Products

ISO 17034 Reference Material Stability and Homogeneity Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The International Organization for Standardization (ISO) is a non-governmental organization that develops and publishes international standards for various industries and applications. ISO 17034, titled General requirements for the competence of reference material producers, provides guidelines for the production of reference materials (RMs). RMs are substances or materials used to calibrate measurement instruments, verify test results, or validate analytical methods.

ISO 17034 is a critical standard in ensuring the quality and reliability of RMs. The standard sets out the requirements for RM producers to demonstrate their competence and ensure that their products meet specific criteria. The standard applies to all types of RMs, including those used in various industries such as chemistry, biology, physics, and materials science.

In addition to ISO 17034, other relevant standards include:

  • ASTM (American Society for Testing and Materials) E2606-19: Standard Practice for Preparing and Characterizing Reference Materials
  • EN 15789:2019: Chemical characterization of reference materials General principles and methods
  • TSE (Turkish Standards Institution) TS ISO/IEC 17034:2018: General requirements for the competence of reference material producers
  • These standards provide a framework for ensuring the quality and reliability of RMs, which is essential for maintaining measurement uncertainty, validating test results, and ensuring product safety.

    Standard Requirements and Needs

    The need for ISO 17034 Reference Material Stability and Homogeneity testing arises from the increasing demand for accurate and reliable measurements in various industries. The consequences of using non-compliant or inadequate RMs can be severe, including:

  • Inaccurate measurement results
  • Poor product quality
  • Increased risk to human health and safety
  • Economic losses due to incorrect testing or calibration
  • The main reasons for conducting ISO 17034 Reference Material Stability and Homogeneity testing include:

    1. Business and Technical Reasons: To ensure the accuracy and reliability of measurements, which is critical for maintaining product quality and ensuring compliance with regulatory requirements.

    2. Consequences of Non-Compliance: Failure to perform this test can result in inaccurate measurement results, poor product quality, increased risk to human health and safety, and economic losses.

    3. Industries and Sectors: This testing is required by various industries, including chemistry, biology, physics, materials science, and more.

    4. Risk Factors and Safety Implications: The use of non-compliant or inadequate RMs can pose significant risks to human health and safety.

    5. Quality Assurance and Quality Control: Performing this test ensures that measurement uncertainty is minimized, and quality control measures are implemented.

    Test Conditions and Methodology

    The ISO 17034 Reference Material Stability and Homogeneity testing service involves a series of steps, including:

    1. Sample Preparation: Preparing the RM samples according to the standard requirements.

    2. Testing Equipment and Instruments: Using state-of-the-art equipment and instruments for measuring properties such as stability and homogeneity.

    3. Testing Environment Requirements: Maintaining specific temperature, humidity, pressure, and other environmental conditions during testing.

    4. Measurement and Analysis Methods: Applying measurement and analysis methods that meet the standard requirements.

    5. Calibration and Validation Procedures: Ensuring that all equipment and instruments are calibrated and validated according to the manufacturers instructions.

    Test Reporting and Documentation

    The test report for ISO 17034 Reference Material Stability and Homogeneity testing includes:

    1. Report Format and Structure: Following a standardized format and structure, as outlined in the standard.

    2. Interpretation of Test Results: Providing a clear explanation of the results and their implications.

    3. Certification and Accreditation Aspects: Including information on certification and accreditation details.

    4. Traceability and Documentation Requirements: Ensuring that all documentation is complete, accurate, and up-to-date.

    Why This Test Should Be Performed

    Performing ISO 17034 Reference Material Stability and Homogeneity testing provides numerous benefits, including:

    1. Quality Assurance and Compliance Benefits: Ensures compliance with regulatory requirements and industry standards.

    2. Risk Assessment and Mitigation: Minimizes the risk of inaccurate measurement results and ensures product safety.

    3. Competitive Advantages and Market Positioning: Demonstrates a commitment to quality and reliability, enhancing market positioning and competitiveness.

    4. Cost Savings and Efficiency Improvements: Reduces costs associated with incorrect testing or calibration and improves efficiency by minimizing rework.

    Why Eurolab Should Provide This Service

    Eurolab is an expert in providing ISO 17034 Reference Material Stability and Homogeneity testing services due to its:

    1. Expertise and Experience: Proven track record of delivering high-quality testing services.

    2. State-of-the-Art Equipment and Facilities: Possesses modern, calibrated, and validated equipment and instruments.

    3. Qualified and Certified Personnel: Staffed by highly trained and certified personnel with extensive experience in RM production.

    Conclusion

    ISO 17034 Reference Material Stability and Homogeneity testing is a critical component of ensuring measurement uncertainty, validating test results, and maintaining product safety. By understanding the standard requirements and needs, test conditions and methodology, test reporting and documentation, and benefits of performing this test, industries can ensure that their RMs meet specific criteria, minimizing risks to human health and safety while enhancing market positioning and competitiveness.

    Eurolab is committed to providing high-quality ISO 17034 Reference Material Stability and Homogeneity testing services, ensuring that your organization meets the required standards and regulations. Contact us today to learn more about our testing services and how we can support your business needs.

    References

  • ISO 17034:2018 General requirements for the competence of reference material producers
  • ASTM E2606-19 Standard Practice for Preparing and Characterizing Reference Materials
  • EN 15789:2019 Chemical characterization of reference materials General principles and methods
  • TSE TS ISO/IEC 17034:2018 General requirements for the competence of reference material producers
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