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iso-17025-stability-testing-accreditation-requirements
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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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 ISO 17025 Stability Testing Accreditation Requirements Laboratory Testing Service by Eurolab

ISO 17025 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories. The standard outlines the principles, processes, and procedures that a laboratory must follow to ensure the accuracy and reliability of its test results. In this section, we will provide comprehensive information about the relevant standards that govern ISO 17025 Stability Testing Accreditation Requirements testing.

International Standards

The International Organization for Standardization (ISO) is responsible for developing and publishing international standards for various industries and applications. The following international standards are relevant to ISO 17025 Stability Testing Accreditation Requirements:

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

  • ISO/IEC 17020:2012 - Conformity assessment -- Requirements for the operation of various types of bodies performing inspection

  • ISO 9001:2015 - Quality management systems -- Requirements

    • National Standards

    National standards are specific to each country or region and may supersede international standards. The following national standards are relevant to ISO 17025 Stability Testing Accreditation Requirements:

  • EN ISO 17025:2017 (European Union)

  • ASTM E1402-11 (USA)

  • TSE 17025:2016 (Turkey)

    • Standard Development Organizations

    Standard development organizations play a crucial role in developing and maintaining standards. The following organizations are responsible for developing standards related to ISO 17025 Stability Testing Accreditation Requirements:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, industry practices, and regulatory requirements. The following are some key updates to standards related to ISO 17025 Stability Testing Accreditation Requirements:

  • ISO 17025:2017 replaced the previous edition (ISO 17025:2005) in November 2017

  • EN ISO 17025:2017 was published in March 2018, replacing the previous edition (EN ISO 17025:2005)

    • Standard Compliance Requirements

    Compliance with relevant standards is a critical requirement for laboratories performing ISO 17025 Stability Testing Accreditation Requirements. The following are some key compliance requirements:

  • Laboratories must demonstrate competence in testing and calibration

  • Laboratories must follow standardized procedures for sampling, testing, and reporting

  • Laboratories must ensure the accuracy, reliability, and reproducibility of test results

    • Standard Numbers and Scope

    The following standard numbers and scope are relevant to ISO 17025 Stability Testing Accreditation Requirements:

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

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

  • ASTM E1402-11 - Standard Guide for Quality System in Laboratories (scope: laboratory quality management)

    • Industry-Specific Examples

    The following are some industry-specific examples where ISO 17025 Stability Testing Accreditation Requirements may be applicable:

  • Pharmaceuticals: stability testing of active pharmaceutical ingredients

  • Cosmetics: stability testing of cosmetic products

  • Food and beverages: stability testing of food and beverage products

    • Please continue to the next section for Standard Requirements and Needs.

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