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ich-q11-stability-of-drug-substances-in-developmental-stages
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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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

Comprehensive Guide to ICH Q11 Stability of Drug Substances in Developmental Stages Laboratory Testing Service by Eurolab

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a global organization that brings together regulatory authorities and industry representatives to harmonize guidelines, standards, and regulations for the pharmaceutical industry. The ICH Q11 Stability of Drug Substances in Developmental Stages testing is one such guideline that aims to ensure the stability and quality of drug substances during their development stages.

The relevant standards that govern this testing service include:

  • ISO 2854:1998 (E) - Sampling procedures for inspection by attributes

  • ASTM E177-15 - Standard Practice for Sampling Strategies for Evaluating Analytical Measurement Uncertainty

  • EN 12662:2017 - Quality control of the manufacture of pharmaceutical products

  • TSE 217:2015 - Pharmaceuticals - Stability testing of active substances and finished pharmaceutical products

    • The legal and regulatory framework surrounding this testing service is governed by various national and international regulations, including:

  • EU GMP (European Union Good Manufacturing Practice) guidelines for pharmaceutical manufacturers

  • FDA guidelines on stability testing for new drug applications in the United States

  • ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical, Physical, and Biological Characteristic and Impurities

    • The international standard development organizations involved in this field include:

  • ISO (International Organization for Standardization)

  • ASTM (American Society for Testing and Materials)

  • EN (European Committee for Electrotechnical Standardization)

  • TSE (Turkish Standards Institution)

    • These standards evolve and get updated regularly to reflect changes in technology, regulations, and industry practices. For example, the latest version of ISO 2854:2015 supersedes the previous edition.

    The standard numbers and their scope are as follows:

  • ISO 2854:1998 - Sampling procedures for inspection by attributes (withdrawn)

  • ASTM E177-15 - Standard Practice for Sampling Strategies for Evaluating Analytical Measurement Uncertainty

  • EN 12662:2017 - Quality control of the manufacture of pharmaceutical products

  • TSE 217:2015 - Pharmaceuticals - Stability testing of active substances and finished pharmaceutical products

    • Standard compliance requirements vary depending on the industry, country, or region. For example:

  • In the EU, pharmaceutical manufacturers must comply with EU GMP guidelines.

  • In the United States, FDA guidelines on stability testing for new drug applications are mandatory.

    • The ICH Q11 Stability of Drug Substances in Developmental Stages testing is essential to ensure the quality and safety of drug substances during their development stages. The business and technical reasons for conducting this test include:

  • Ensuring that the active pharmaceutical ingredient (API) remains stable over time

  • Verifying the physical, chemical, and biological properties of the API

  • Evaluating the potential impact of environmental factors on the APIs stability

  • Meeting regulatory requirements for new drug applications

    • The consequences of not performing this test are severe:

  • Failure to comply with regulatory requirements may lead to rejection of a new drug application.

  • Inadequate testing may result in product recalls, damaged reputation, and financial losses.

    • The industries that require this testing include:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Research institutions

    • The risk factors and safety implications associated with this test include:

  • Unstable APIs can lead to adverse reactions or reduced efficacy of the final product.

  • Failure to detect impurities or degradation products can compromise product safety.

    • Quality assurance and quality control aspects are crucial in ensuring the accuracy and reliability of the testing results. This includes:

  • Calibration and validation of equipment

  • Use of certified reference materials

  • Documenting and reporting testing procedures

    • This test contributes significantly to product safety and reliability by:

  • Ensuring that APIs remain stable over time.

  • Verifying physical, chemical, and biological properties of APIs.

  • Evaluating the potential impact of environmental factors on API stability.

    • The competitive advantages of having this testing performed include:

  • Compliance with regulatory requirements.

  • Increased customer confidence and trust.

  • Enhanced product safety and reliability.

    • The cost-benefit analysis of performing this test is favorable:

  • Avoidance of potential financial losses due to non-compliance or product recalls.

  • Reduced risk of adverse reactions or reduced efficacy.

    • The ICH Q11 Stability of Drug Substances in Developmental Stages testing involves the following steps:

    1. Sample Preparation: The API is prepared according to established procedures, including grinding, sieving, and packaging.

    2. Testing Equipment and Instruments: State-of-the-art equipment, such as stability chambers, spectroscopy instruments, and chromatography systems, are used for testing.

    3. Testing Environment Requirements: The testing environment must be controlled at specific temperatures (e.g., 25C 2C) and humidity levels (e.g., 60 5) to simulate real-world conditions.

    4. Analytical Methods: Standardized analytical methods, such as high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and spectroscopy, are used for testing.

    5. Data Analysis: The data is analyzed using statistical software to determine the stability of the API.

    The following instruments may be used during this test:

  • Stability chambers

  • Spectroscopy instruments (e.g., UV/Vis, IR)

  • Chromatography systems (e.g., HPLC, GC-MS)

  • Analytical balances

  • pH meters

    • Conclusion

    In conclusion, the ICH Q11 Stability of Drug Substances in Developmental Stages testing is a critical step in ensuring the quality and safety of drug substances during their development stages. Compliance with regulatory requirements, increased customer confidence, and enhanced product safety and reliability are just some of the benefits associated with this test.

    Perspective from Eurolab

    At Eurolab, we understand the importance of accurate and reliable testing results in ensuring the quality and safety of pharmaceutical products. Our state-of-the-art laboratory facilities and expert team ensure that our clients receive high-quality services that meet or exceed regulatory requirements.

    We invite you to contact us for more information on how we can assist with your ICH Q11 Stability of Drug Substances in Developmental Stages testing needs.

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

    CONTACT US +902127020000

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