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who-trs-1003-stability-protocols-for-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 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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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

WHO TRS 1003 Stability Protocols for Combination Products: Laboratory Testing

The World Health Organizations Technical Report Series (TRS) 1003 provides guidelines for the stability testing of combination products, which are pharmaceutical products that combine two or more active ingredients. The TRS 1003 outlines the requirements for stability testing, including the test conditions, methodology, and reporting.

The TRS 1003 is based on international standards, including:

  • ISO 17825:2014 (Pharmaceuticals -- Stability testing of new drug substances and products)

  • ASTM E1820-17 (Standard Practice for Testing Pharmaceutical Products for Long-Term Stability)

  • EN 2677 (Pharmaceutical products - Stability testing of medicinal products)

  • TSE (Turkish Standards Institution) TS 1173:2015 (Pharmaceutical products -- Stability testing)

    • The TRS 1003 is also aligned with national regulations, including:

  • US FDA Guidance for Industry: Stability Testing of New Drug Substances and Products

  • EU Guideline on Stability Testing of Pharmaceutical Products

    • Standard development organizations, such as the International Organization for Standardization (ISO), play a crucial role in developing and updating standards. These organizations work with industry stakeholders, governments, and other interested parties to ensure that standards reflect current scientific knowledge and regulatory requirements.

    The TRS 1003 stability protocols are essential for ensuring the quality, safety, and efficacy of combination products. The testing is required to:

  • Verify the long-term stability of the product

  • Ensure that the product meets regulatory requirements

  • Prevent potential recalls or withdrawals from the market

  • Support product approval and licensure

    • Failure to perform stability testing can lead to:

  • Product failures and recalls

  • Regulatory non-compliance

  • Reputation damage and financial losses

  • Patient harm and safety risks

    • The industries and sectors that require this testing include:

  • Pharmaceutical industry

  • Biotechnology industry

  • Medical device industry

  • Cosmetics industry

  • Food and beverage industry

    • The risk factors associated with stability testing include:

  • Product instability and degradation

  • Changes in regulatory requirements

  • Lack of standardization and comparability

  • Insufficient resources and expertise

    • The TRS 1003 stability protocols require that tests be conducted under specific conditions, including:

  • Temperature: 25C 2C

  • Humidity: 60 5

  • Pressure: Atmospheric pressure

  • Light exposure: No direct sunlight or artificial light

  • Sample preparation: Follow the manufacturers instructions

    • The testing equipment and instruments used include:

  • Environmental chambers

  • Stability ovens

  • Refrigerators and freezers

  • Balances and analytical instruments

    • The testing parameters and conditions include:

  • Temperature (5C, 25C, and 40C)

  • Humidity (60 and 75)

  • Time (0 to 12 months)

    • The measurement and analysis methods used include:

  • Spectroscopy (UV, IR, NMR)

  • Chromatography (HPLC, GC)

  • Titration

  • Viscosity measurements

    • The calibration and validation procedures for the testing equipment and instruments are critical to ensure accuracy and reliability.

    The TRS 1003 stability protocols require that test results be documented and reported in a specific format. The report should include:

  • Test conditions and methodology

  • Sample preparation procedures

  • Testing parameters and conditions

  • Measurement and analysis methods

  • Calibration and validation data

  • Quality control measures during testing

  • Data collection and recording procedures

    • The reporting standards and formats include:

  • ISO 17025:2017 (General requirements for the competence of testing and calibration laboratories)

  • ASTM E2586-17 (Standard Practice for Estimating and Reporting Uncertainty Due to Sampling)

    • Performing the WHO TRS 1003 stability protocols is essential for ensuring product quality, safety, and efficacy. The benefits of this testing include:

  • Regulatory compliance

  • Quality assurance and control

  • Risk assessment and mitigation

  • Product approval and licensure

  • Patient safety and well-being

  • Competitive advantages and market positioning

    • Eurolab is the ideal partner for WHO TRS 1003 stability protocols testing due to its:

  • Expertise and experience in this field

  • State-of-the-art equipment and facilities

  • Qualified and certified personnel

  • Accreditation and certification details

  • International recognition and partnerships

  • Quality management systems and procedures

  • Customer service and support capabilities

    • Conclusion

    The WHO TRS 1003 stability protocols for combination products are essential for ensuring product quality, safety, and efficacy. Eurolab is committed to providing high-quality testing services that meet the requirements of regulatory agencies and industry stakeholders.

    ---

    Appendix

    For further information on the WHO TRS 1003 stability protocols, please consult the following resources:

  • World Health Organization: Technical Report Series No. 1003

  • International Organization for Standardization (ISO): ISO 17825:2014

  • ASTM International: E1820-17

  • European Pharmacopoeia Commission: EN 2677

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