EUROLAB
iso-20387-stability-assessment-in-biobanking-sample-storage
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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 17034 Reference Material Stability and HomogeneityISO 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

Comprehensive Guide to ISO 20387 Stability Assessment in Biobanking Sample Storage Laboratory Testing Service Provided by Eurolab

ISO 20387 is a critical standard for the stability assessment of biobanked samples, ensuring that these precious resources are handled and stored with the utmost care. As a leading provider of laboratory testing services, Eurolab is committed to delivering high-quality results that meet or exceed this international standard.

The Legal and Regulatory Framework

ISO 20387 was developed by the International Organization for Standardization (ISO) in collaboration with experts from around the world. This standard is now recognized as an essential requirement for biobanking organizations seeking to maintain their reputation, credibility, and compliance with regulatory requirements.

At Eurolab, we understand that our clients must navigate a complex landscape of regulations and standards governing laboratory testing services. We will guide you through this process, ensuring that your samples are handled and analyzed in accordance with the most up-to-date international standards.

International and National Standards

ISO 20387 is part of a broader family of standards addressing the storage and handling of biobanked materials. Some key related standards include:

  • ISO 15189:2012 (Requirements for quality management systems in medical laboratories)
  • ASTM E2606-15 (Standard Practice for Storage and Handling of Specimens Collected from Living Organisms)
  • EN 15490:2008 (Biological safety cabinets)
  • TSE EN ISO 14155:2015 (Clinical investigation of medical devices for human subjects)
  • Standard Development Organizations

    The International Organization for Standardization (ISO) is a non-profit organization that develops and publishes international standards. Other prominent standard development organizations include the American Society for Testing and Materials (ASTM), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE).

    How Standards Evolve and Get Updated

    Standards are living documents, reflecting the ongoing evolution of science, technology, and regulatory requirements. As new research emerges or regulations change, standards must be updated to reflect these developments.

    Eurolab stays at the forefront of this process, ensuring that our testing services remain aligned with the latest international standards.

    Standard Compliance Requirements for Different Industries

    Biobanking organizations across various industries including pharmaceuticals, biotechnology, and academia rely on ISO 20387 to ensure the integrity and reliability of their samples. Compliance with this standard is essential for maintaining regulatory approval, ensuring data quality, and protecting intellectual property.

    By partnering with Eurolab, you can rest assured that your testing requirements will be met while navigating the complex landscape of standards and regulations.

    Why This Specific Test is Needed and Required

    ISO 20387 Stability Assessment in Biobanking Sample Storage is a critical test for ensuring the reliability and accuracy of biobanked samples. These samples are often used in research, product development, and clinical trials, making their quality control essential.

    The consequences of non-compliance can be severe:

  • Data quality may be compromised, leading to inaccurate conclusions or failed experiments.
  • Regulatory approvals may be revoked, threatening business continuity and reputation.
  • Intellectual property protection is at risk, jeopardizing innovation and competitiveness.
  • Business and Technical Reasons for Conducting ISO 20387 Stability Assessment

    Biobanking organizations recognize the importance of this test due to:

  • The increasing demand for high-quality samples in research and product development
  • The need to maintain regulatory compliance and approval
  • The desire to protect intellectual property and competitive advantage
  • By conducting ISO 20387 Stability Assessment, biobanking organizations can ensure the integrity and reliability of their samples, mitigating risks and ensuring data quality.

    Consequences of Not Performing This Test

    The consequences of not performing this test are severe:

  • Data quality may be compromised
  • Regulatory approvals may be revoked
  • Intellectual property protection is at risk
  • In addition to these consequences, non-compliance can also lead to reputational damage, financial losses, and a loss of competitive advantage.

    Industries and Sectors that Require This Testing

    Biobanking organizations across various industries including pharmaceuticals, biotechnology, and academia rely on ISO 20387 to ensure the integrity and reliability of their samples. Compliance with this standard is essential for maintaining regulatory approval, ensuring data quality, and protecting intellectual property.

    Risk Factors and Safety Implications

    The stability assessment of biobanked samples involves several risk factors, including:

  • Contamination and degradation of samples
  • Equipment failure or malfunction
  • Human error in handling and storing samples
  • Eurolabs team of experts is committed to ensuring the highest level of quality control and safety during testing.

    Quality Assurance and Quality Control Aspects

    At Eurolab, we recognize the importance of quality assurance and quality control in laboratory testing services. We adhere to strict quality control measures to ensure that our results meet or exceed international standards:

  • Sample handling and preparation
  • Equipment calibration and maintenance
  • Data analysis and reporting
  • Why Choose Eurolab for ISO 20387 Stability Assessment?

    By partnering with Eurolab, you can rest assured that your testing requirements will be met while navigating the complex landscape of standards and regulations. Our team of experts is committed to delivering high-quality results that meet or exceed international standards.

    We offer a comprehensive range of laboratory testing services, including:

  • Sample storage and handling
  • Equipment calibration and maintenance
  • Data analysis and reporting
  • Test Methodology

    Our ISO 20387 Stability Assessment test methodology includes:

    1. Sample Preparation: Samples are handled and prepared according to strict protocols to prevent contamination and degradation.

    2. Equipment Calibration: Our equipment is calibrated regularly to ensure accuracy and precision in testing.

    3. Data Analysis: Data is analyzed using advanced software and statistical methods to provide reliable results.

    Test Reports and Certificates

    Eurolab provides detailed test reports and certificates of compliance, ensuring that our clients have the necessary documentation for regulatory approval and intellectual property protection.

    Turnaround Time

    Our team works efficiently to deliver high-quality results within a short turnaround time. We understand the importance of meeting deadlines in research, product development, and clinical trials.

    Pricing and Packages

    We offer competitive pricing and customized packages tailored to meet the specific needs of our clients. Our goal is to provide exceptional value while delivering high-quality results that meet or exceed international standards.

    Conclusion

    ISO 20387 Stability Assessment in Biobanking Sample Storage is a critical test for ensuring the reliability and accuracy of biobanked samples. By partnering with Eurolab, you can rest assured that your testing requirements will be met while navigating the complex landscape of standards and regulations.

    Our team of experts is committed to delivering high-quality results that meet or exceed international standards. Contact us today to learn more about our laboratory testing services and how we can support your biobanking needs.

    Appendix

  • ISO 20387:2018 (Biological samples - Stability evaluation)
  • ASTM E2606-15 (Standard Practice for Storage and Handling of Specimens Collected from Living Organisms)
  • EN 15490:2008 (Biological safety cabinets)
  • Please note that this comprehensive guide is a general overview of the ISO 20387 standard. For more specific information or to request a customized testing package, please contact our team of experts at Eurolab.

    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