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ema-stability-testing-of-drug-device-combination-products
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 FormulationsEP 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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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

EMA Stability Testing of Drug-Device Combination Products: A Comprehensive Guide

As the demand for innovative drug-device combination products continues to rise, regulatory bodies have established strict guidelines to ensure their safety and efficacy. One such critical testing requirement is EMA (European Medicines Agency) stability testing, which evaluates the products degradation over time under various environmental conditions. In this comprehensive guide, we will delve into the world of EMA stability testing, exploring the relevant standards, requirements, and benefits of this laboratory test.

STANDARD-RELATED INFORMATION

EMA stability testing is governed by a range of international and national standards, including:

  • ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes)

  • ISO 11137-1:2012 (Gamma radiation sterilization Part 1: General requirements)

  • EN ISO 10993-13:2010 (Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric materials)

  • TSE (Turkish Standards Institution) TS EN ISO 11607-1:2015 (Packaging for terminally sterilized medical devices Part 1: Requirements)

    • These standards ensure that drug-device combination products are designed, manufactured, and tested to meet the required safety and performance standards.

    The European Medicines Agency (EMA) plays a crucial role in establishing regulatory guidelines for pharmaceuticals and medical devices. The EMAs Committee for Medicinal Products for Human Use (CHMP) evaluates the safety and efficacy of medicinal products, including drug-device combination products. EMA stability testing is a critical component of this evaluation process.

    STANDARD REQUIREMENTS AND NEEDS

    EMA stability testing is essential to ensure that drug-device combination products remain stable over time, maintaining their safety and efficacy. This test assesses the products degradation under various environmental conditions, such as temperature, humidity, and light exposure.

    The business and technical reasons for conducting EMA stability testing include:

  • Ensuring product safety and efficacy

  • Complying with regulatory requirements

  • Maintaining product quality and consistency

  • Reducing the risk of product recalls and litigation

  • Improving customer confidence and trust

    • Failure to perform EMA stability testing can result in:

  • Regulatory non-compliance

  • Product recalls and reputational damage

  • Financial losses due to rework or replacement costs

  • Decreased customer satisfaction and loyalty

    • TEST CONDITIONS AND METHODOLOGY

    EMA stability testing involves a series of complex procedures, including:

    1. Sample preparation: The product is prepared according to the manufacturers instructions, taking into account any specific requirements for packaging, labeling, and handling.

    2. Testing equipment and instruments: Sophisticated equipment, such as temperature and humidity chambers, light exposure units, and analytical instruments (e.g., chromatography, spectroscopy), are used to simulate various environmental conditions.

    3. Testing environment requirements: The testing environment must meet specific standards for temperature, humidity, pressure, and light exposure to accurately replicate real-world conditions.

    4. Measurement and analysis methods: Advanced analytical techniques, such as chromatography and spectroscopy, are employed to detect and quantify degradation products.

    5. Calibration and validation procedures: Regular calibration and validation of equipment ensure accurate and reliable test results.

    TEST REPORTING AND DOCUMENTATION

    EMA stability testing reports must adhere to specific formats and standards, including:

  • ISO 13485:2016 (Medical devices Quality management systems Requirements for regulatory purposes)

  • EN ISO 11137-1:2012 (Gamma radiation sterilization Part 1: General requirements)

    • The report should include:

  • Test parameters and conditions

  • Sample preparation procedures

  • Testing equipment and instruments used

  • Results of measurement and analysis methods

  • Conclusion and recommendations

    • WHY THIS TEST SHOULD BE PERFORMED

    EMA stability testing offers numerous benefits, including:

  • Ensuring product safety and efficacy

  • Maintaining regulatory compliance

  • Improving quality assurance and control

  • Enhancing customer confidence and trust

  • Supporting innovation and research development

    • By performing EMA stability testing, companies can reduce the risk of product recalls, litigation, and financial losses, while improving their reputation and market positioning.

    WHY EUROLAB SHOULD PROVIDE THIS SERVICE

    Eurolab is an expert in EMA stability testing, offering:

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel with extensive experience

  • Accreditation and certification to international standards (e.g., ISO 13485:2016)

  • International recognition and partnerships with regulatory bodies

  • Comprehensive quality management systems and procedures

  • Dedicated customer service and support

    • By partnering with Eurolab, companies can ensure the highest level of accuracy, reliability, and compliance in their EMA stability testing.

    CONCLUSION

    EMA stability testing is a critical component of ensuring the safety and efficacy of drug-device combination products. By understanding the relevant standards, requirements, and benefits of this laboratory test, companies can maintain regulatory compliance, reduce risk, and improve their reputation and market positioning.

    At Eurolab, we are committed to providing expert EMA stability testing services, helping our clients navigate the complex world of pharmaceutical and medical device regulation.

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

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