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usp-671-stability-testing-of-packaging-materials
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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 <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

USP <671> Stability Testing of Packaging Materials: Eurolabs Laboratory Testing Service

Standard-Related Information

The stability testing of packaging materials is a critical aspect of ensuring the quality and safety of pharmaceutical products. This article will provide an in-depth examination of the relevant standards, regulatory framework, and industry requirements for USP <671> Stability Testing of Packaging Materials.

1.1 Overview of Relevant Standards

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the identity, strength, quality, and purity of substances used in the pharmaceutical industry. USP <671> Stability Testing of Packaging Materials is one of the guidelines that ensure packaging materials are suitable for storing and transporting pharmaceutical products.

Other relevant standards include:

  • ISO 11609:2013: Non-aqueous titration of nickel and other metals

  • ASTM D543: Effects of liquids on plastics and coatings

  • EN 12892:2012: Packaging. Returnable pallets for materials handling equipment

    • 1.2 Legal and Regulatory Framework

    The regulatory framework surrounding USP <671> Stability Testing of Packaging Materials is governed by various laws and regulations, including:

  • FDC Act (21 CFR): Federal Food, Drug, and Cosmetic Act

  • USP-NF: United States Pharmacopeia-National Formulary

  • ICH Q7A: Good Manufacturing Practice for Active Pharmaceutical Ingredients

    • These regulations require pharmaceutical companies to ensure the packaging materials used in their products meet specific standards for stability, durability, and safety.

    1.3 International and National Standards

    International organizations such as the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) develop standards for packaging materials. National standards, like those developed by the American Society for Testing and Materials (ASTM), also play a crucial role in ensuring compliance.

    1.4 Standard Development Organizations

    Standard development organizations (SDOs) are responsible for creating and maintaining standards. These organizations include:

  • ISO: International Organization for Standardization

  • CEN: European Committee for Standardization

  • ASTM: American Society for Testing and Materials

    • SDOs work closely with industry stakeholders, regulatory bodies, and other experts to develop standards that meet the needs of various industries.

    1.5 Evolution of Standards

    Standards evolve over time as new technologies emerge, and industry needs change. This ensures that standards remain relevant and effective in protecting public health and safety.

    Standard Requirements and Needs

    2.1 Why USP <671> Stability Testing is Required

    The stability testing of packaging materials is essential to ensure the quality and safety of pharmaceutical products. Without proper testing, there is a risk of contamination, degradation, or leakage of the product during storage or transportation.

    2.2 Business and Technical Reasons for Conducting USP <671> Stability Testing

    Conducting USP <671> stability testing provides several benefits:

  • Ensures compliance with regulatory requirements

  • Protects public health and safety

  • Prevents product recalls and financial losses

  • Enhances brand reputation and customer trust

  • Facilitates international trade and market access

    • 2.3 Consequences of Not Performing USP <671> Stability Testing

    Failing to conduct USP <671> stability testing can lead to:

  • Contamination or degradation of products

  • Product recalls and financial losses

  • Loss of business reputation and customer trust

  • Regulatory non-compliance

    • Test Conditions and Methodology

    3.1 Test Conducted by Eurolab

    Eurolab conducts USP <671> stability testing using state-of-the-art equipment and following strict protocols.

    3.2 Testing Equipment and Instruments Used

    The equipment used for USP <671> stability testing includes:

  • Temperature-controlled chambers

  • Humidity control systems

  • Pressure gauges

  • Leak detection equipment

    • 3.3 Testing Environment Requirements

    The testing environment must meet specific conditions, including temperature, humidity, and pressure.

    3.4 Sample Preparation Procedures

    Samples are prepared according to the USP <671> guidelines, ensuring accurate and reliable results.

    Test Reporting and Documentation

    4.1 Test Results Documentation and Reporting

    Eurolab documents test results in a clear and concise manner, following international reporting standards.

    4.2 Report Format and Structure

    Reports include:

  • Introduction

  • Methodology

  • Results

  • Discussion

  • Conclusion

    • Why This Test Should Be Performed

    5.1 Benefits of Performing USP <671> Stability Testing

    Performing USP <671> stability testing provides numerous benefits, including:

  • Ensures compliance with regulatory requirements

  • Protects public health and safety

  • Prevents product recalls and financial losses

  • Enhances brand reputation and customer trust

  • Facilitates international trade and market access

    • Why Eurolab Should Provide This Service

    6.1 Expertise and Experience

    Eurolab has extensive expertise in USP <671> stability testing, ensuring accurate and reliable results.

    6.2 State-of-the-Art Equipment and Facilities

    Eurolabs state-of-the-art equipment and facilities ensure high-quality testing services.

    Conclusion

    In conclusion, USP <671> stability testing of packaging materials is a critical aspect of ensuring the quality and safety of pharmaceutical products. Eurolabs expertise, state-of-the-art equipment, and strict protocols make it an ideal partner for companies seeking reliable results.

    References:

    1. United States Pharmacopeia (USP). (2018). <671> Stability Testing of Packaging Materials.

    2. International Organization for Standardization (ISO). (2013). ISO 11609:2013 Non-aqueous titration of nickel and other metals.

    3. American Society for Testing and Materials (ASTM). (2019). ASTM D543 Effects of liquids on plastics and coatings.

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    Eurolabs commitment to quality, expertise, and customer satisfaction makes it an ideal partner for companies seeking reliable USP <671> stability testing services.

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