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ema-guideline-on-holding-times-for-bulk-products-stability-implication
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 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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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

Eurolabs EMA Guideline on Holding Times for Bulk Products (Stability Implication) Laboratory Testing Service

Standard-Related Information

The European Medicines Agency (EMA) has published a guideline on holding times for bulk products, which is essential for ensuring the stability and quality of pharmaceuticals. This guideline is based on international standards and regulations, including those from ISO, ASTM, EN, TSE, and other organizations.

Relevant Standards

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

  • ASTM E2234-15 - Standard Practice for Determining Resistance of Materials to Fungal Degradation

  • EN ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • TSE L09.01 - General requirements for the competence of testing laboratories

    • Standard Development Organizations

    Standard development organizations, such as ISO, ASTM, and EN, play a crucial role in developing and maintaining international standards. These organizations work together to ensure that standards are aligned and meet the needs of industries worldwide.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. Eurolab stays up-to-date with the latest standards and updates to ensure that our laboratory testing services meet the highest standards.

    International and National Standards

    The following international and national standards apply to EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing:

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

  • ASTM E2234-15 - Standard Practice for Determining Resistance of Materials to Fungal Degradation

  • EN ISO 14644-1:2015 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

  • TSE L09.01 - General requirements for the competence of testing laboratories

    • Standard Compliance Requirements

    Compliance with standards is essential for industries that require laboratory testing services, including pharmaceuticals, biotechnology, and cosmetics.

    Standard-Related Information

    The following information provides a comprehensive overview of standard-related aspects:

  • Why Standards are Important: Standards ensure consistency, quality, and safety in laboratory testing services.

  • Consequences of Non-Compliance: Failure to comply with standards can result in product recalls, fines, and damage to reputation.

  • International and National Standards: Eurolab adheres to international (ISO, ASTM) and national (EN, TSE) standards for EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing.

    • Standard Requirements and Needs

    This section explains the need for EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing:

    Business and Technical Reasons

  • Business Reasons: Laboratory testing services ensure product quality, safety, and compliance with regulations.

  • Technical Reasons: Eurolabs state-of-the-art equipment and facilities enable accurate and reliable test results.

    • Consequences of Not Performing This Test

    Failure to perform this test can result in:

  • Product Recalls

  • Fines and Penalties

  • Damage to Reputation

    • Industries and Sectors

    The following industries require EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing services:

  • Pharmaceuticals

  • Biotechnology

  • Cosmetics

    • Risk Factors and Safety Implications

    Laboratory testing services minimize risks by ensuring product quality, safety, and compliance with regulations.

    Quality Assurance and Quality Control

    Eurolabs quality assurance and quality control measures ensure accurate and reliable test results:

  • Sample Preparation

  • Testing Parameters and Conditions

  • Measurement and Analysis Methods

    • Test Conditions and Methodology

    This section provides a detailed explanation of the EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing methodology:

    Testing Equipment and Instruments

    Eurolab uses state-of-the-art equipment and instruments to ensure accurate and reliable test results.

    Testing Environment Requirements

    The following conditions are required for EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing:

  • Temperature

  • Humidity

  • Pressure

    • Sample Preparation Procedures

    Eurolab follows strict sample preparation procedures to ensure accurate and reliable test results.

    Testing Parameters and Conditions

    The following parameters and conditions are used for EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing:

  • Temperature

  • Humidity

  • Pressure

    • Measurement and Analysis Methods

    Eurolab uses advanced measurement and analysis methods to ensure accurate and reliable test results.

    Calibration and Validation

    Calibration and validation procedures are essential for ensuring the accuracy and reliability of laboratory testing services.

    Test Report and Certification

    The following information is included in a standard test report:

  • Test Results

  • Certification Statement

    • Quality Control Measures

    Eurolabs quality control measures ensure accurate and reliable test results:

  • Sample Preparation

  • Testing Parameters and Conditions

  • Measurement and Analysis Methods

    • Sample Preparation

    Eurolab follows strict sample preparation procedures to ensure accurate and reliable test results.

    Testing Parameters and Conditions

    The following parameters and conditions are used for EMA Guideline on Holding Times for Bulk Products (Stability Implication) testing:

  • Temperature

  • Humidity

  • Pressure

    • Measurement and Analysis Methods

    Eurolab uses advanced measurement and analysis methods to ensure accurate and reliable test results.

    Calibration and Validation

    Calibration and validation procedures are essential for ensuring the accuracy and reliability of laboratory testing services.

    Test Report and Certification

    The following information is included in a standard test report:

  • Test Results

  • Certification Statement

    • Quality Control Measures

    Eurolabs quality control measures ensure accurate and reliable test results:

  • Sample Preparation

  • Testing Parameters and Conditions

  • Measurement and Analysis Methods

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

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