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ema-stability-testing-in-pediatric-formulations
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 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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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 in Pediatric Formulations: A Comprehensive Guide

Introduction

EMA (European Medicines Agency) stability testing is a critical aspect of ensuring the quality and efficacy of pediatric formulations. As a leading laboratory testing service provider, Eurolab offers EMA stability testing for pediatric formulations, helping pharmaceutical companies ensure compliance with regulatory requirements while maintaining product safety and reliability.

Standard-Related Information

EMA stability testing in pediatric formulations is governed by various international and national standards. The relevant standards include:

  • ISO 11137:2012 - Sterilization of health care products - Moist heat sterilization - Requirements for the development, validation and routine control of a sterilization process for medical devices

  • ASTM E2524-11 - Standard Practice for Evaluating the Stability of Reagents Used in Pharmaceutical Analysis

  • EN 13640:2002 - Sterilization of single-use medical devices incorporating soil or similar materials by ethylene oxide (EO) or gas plasma sterilization

  • TSE 15704:2011 - Sterilizasyonlu sağlık ürünleri - Sağlık ürünlerinin sterilizasyonu ve dekontaminasyonu için genel kurallar

  • FDA Guidelines for Stability Testing of Drug Products Containing New Chemical Entities

    • These standards outline the requirements for stability testing, including:

  • Temperature and humidity conditions

  • Storage and handling procedures

  • Sampling and analysis methods

  • Data validation and reporting

    • Standard Requirements and Needs

    EMA stability testing in pediatric formulations is essential to ensure product safety and efficacy. The consequences of not performing this test include:

  • Product Failure: Stability testing ensures that the product remains stable over time, preventing degradation and ensuring its effectiveness.

  • Regulatory Non-Compliance: Failure to comply with regulatory requirements can result in costly fines and damage to a companys reputation.

  • Patient Safety: Unstable products can pose health risks to patients, which can lead to serious consequences.

    • The industries that require EMA stability testing in pediatric formulations include:

  • Pharmaceutical companies

  • Biotechnology firms

  • Medical device manufacturers

    • Test Conditions and Methodology

    EMA stability testing in pediatric formulations involves the following steps:

    1. Sample Preparation: Samples are prepared according to established protocols, including packaging, labeling, and storage.

    2. Testing Equipment and Instruments: Equipment such as temperature control units, humidity chambers, and analytical instruments like HPLC (High-Performance Liquid Chromatography) or GC (Gas Chromatography).

    3. Testing Environment Requirements: Temperature and humidity conditions are maintained according to the relevant standards (e.g., 25C 2C and 60 5 relative humidity).

    4. Measurement and Analysis Methods: Analytical methods, such as HPLC or GC, are used to measure the degradation of active pharmaceutical ingredients.

    5. Calibration and Validation Procedures: Equipment is calibrated and validated according to established protocols.

    6. Data Collection and Recording Procedures: Data is collected and recorded in accordance with regulatory requirements.

    Test Reporting and Documentation

    EMA stability testing reports must include:

  • Summary Report: A summary of the test results, including any deviations or issues encountered during testing.

  • Detailed Test Results: Detailed test results, including analytical data and any observations made during testing.

  • Conclusion and Recommendations: Conclusion and recommendations based on the test results.

    • Why This Test Should Be Performed

    The benefits of performing EMA stability testing in pediatric formulations include:

  • Risk Assessment and Mitigation: Stability testing helps identify potential risks associated with product degradation.

  • Quality Assurance and Compliance Benefits: Ensuring compliance with regulatory requirements while maintaining product quality.

  • Competitive Advantages and Market Positioning: Demonstrating commitment to product safety and efficacy, which can enhance a companys reputation and market position.

  • Cost Savings and Efficiency Improvements: Identifying potential issues early on can prevent costly re-work or recalls.

    • Why Eurolab Should Provide This Service

    Eurolab offers EMA stability testing in pediatric formulations due to its:

  • Expertise and Experience: Our team of experts has extensive experience in stability testing.

  • State-of-the-Art Equipment: Our laboratory is equipped with the latest equipment and technology.

  • Accreditation and Certification: We are accredited by relevant national and international bodies, ensuring compliance with regulatory requirements.

  • Quality Management Systems: Our quality management systems ensure that all tests are performed according to established protocols.

    • Conclusion

    EMA stability testing in pediatric formulations is a critical aspect of ensuring product safety and efficacy. As a leading laboratory testing service provider, Eurolab offers comprehensive EMA stability testing services for pediatric formulations, helping pharmaceutical companies maintain compliance with regulatory requirements while maintaining product quality and reliability.

    References:

  • ISO 11137:2012

  • ASTM E2524-11

  • EN 13640:2002

  • TSE 15704:2011

  • FDA Guidelines for Stability Testing of Drug Products Containing New Chemical Entities

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