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usp-1079-good-storage-and-distribution-practices-leachable-risk
Extractables and Leachables 21 CFR 174.5 General Requirements for Indirect Food Additives – E&L21 CFR 175.300 Resinous and Polymeric Coatings – Leachables Control21 CFR 176.170 Substances in Contact with Aqueous Foods – Extractables21 CFR 177.1520 Leachable Migration Limits for Polyolefins21 CFR 177.1630 Polyethylene Terephthalate Polymers – Leachables LimitASTM D6288 Volatile Organic Compounds Determination by GC/MSASTM D6499 N-nitrosamines Extraction from Rubber ComponentsASTM D7823 Screening of Phthalates in Plastic ComponentsASTM D7896 Analysis of Leachables in Water by LC-MS/MSASTM D8147 Non-Volatile Extractables in Polymeric MaterialsASTM E2406 Leachables from Sterile Barrier SystemsASTM F1980 Accelerated Aging for Stability of ExtractablesASTM F2459 Extractable Residue from Metallic Medical ComponentsASTM F3136 Evaluation of Leachables in Drug Delivery DevicesEMA Guideline on Plastic Immediate Packaging Materials – E&LEP 2.9.47 Container Closure System Integrity Testing for ExtractablesEP 3.1.3 Polyolefins in Contact with Injectable PreparationsEP 3.1.4 Polypropylene for Containers in ParenteralsEP 3.1.5 Polyethylene Used in Pharmaceutical ContainersEP 3.1.6 Polyethylene Terephthalate Containers – Leachable SafetyEP 3.2.2 Plastic Containers and Closures for Pharmaceutical UseEP 3.2.8 Closures for Containers for Aqueous Parenteral PreparationsEP 3.2.9 Rubber Closures – Extractables AnalysisEP 5.1.1 Biological Safety – Leachables Toxicity AssessmentFDA 21 CFR 211.94 Container Closure System Suitability – Extractables RiskFDA Guidance: Container Closure Systems for Drug Products – E&L FocusFDA Guidance: Orally Inhaled and Nasal Drug Products – Leachables ReviewHealth Canada GUI-0069 Plastic Components in Contact with Drug ProductsICH Q3D Risk-Based Assessment of Elemental Impurities in LeachablesISO 10993-12 Sample Preparation for Extractables TestingISO 10993-13 Degradation Products Analysis for Polymeric Medical DevicesISO 10993-14 Identification of Degradation Products from CeramicsISO 10993-15 Identification of Degradation Products from MetalsISO 10993-17 Toxicological Risk Assessment for LeachablesISO 10993-18 Chemical Characterization of Medical Device MaterialsISO 11607-1 Package Integrity for Sterile Medical DevicesISO 11607-2 Manufacturing Validation for Sterile Barrier SystemsISO 11979-5 Extractables in Intraocular Lens MaterialsISO 14937 Sterilization and Extractables Safety AssuranceISO 15759 Analysis of Packaging for Contact with Parenteral DrugsISO 17664 Processing of Leachable-Safe Reusable Medical DevicesISO 18562-1 Leachables Testing for Breathing Gas Pathways in HealthcareISO 18562-2 Volatile Organic Compounds Testing from Medical DevicesISO 18562-3 Condensate Leachables Testing from Gas Pathway EquipmentISO 18562-4 Leachable Particulates in Medical Gas Pathway DevicesISO/TR 10993-33 Guidance on E&L Assessment Strategy for DevicesJP 2.20 Extractables from Rubber Stoppers by GC-MSJP 6.02 Aluminum Cap Material Leachables TestingJP 6.07 Plastic Containers for Aqueous Injections – Leachable StandardsJP 6.10 Gas Permeability and Volatile Leachable ReleaseJP 7.02 Residual Solvent and Leachable IdentificationJP 7.04 Container/Closure Leachable Migration EvaluationPDA TR No. 66 Defining Leachables Risk in Biologics ProductionPDA TR No. 85 Extractables and Leachables in Manufacturing SystemsPh. Int. General Method 3.10 Leachable Profiling of Packaging MaterialsUSP <1031.1> Analytical Instrument Qualification for Extractables StudiesUSP <1031> Analytical Method Validation for Extractables StudiesUSP <1058> Analytical Instrument Qualification for Leachables TestingUSP <1086> Impurities – Extractables Risk ProfilingUSP <1088> Inhalation and Nasal Drug Products – Leachables TestingUSP <1207> Container Closure Integrity and Leachable EntryUSP <1231> Water for Pharmaceutical Purposes – Leachables RiskUSP <1661> Evaluation of Plastic Packaging Systems for Drug ProductsUSP <1663> Extractables Testing for Plastic Components in Drug PackagingUSP <1664> Leachables Analysis for Container Closure SystemsUSP <381> Elastomeric Closures for Injections: Extractable ProfileUSP <601> Aerosols – Extractables in Metered Dose InhalersUSP <661.1> Physicochemical Testing of Plastic Packaging SystemsUSP <661.2> Biological Reactivity Tests for Plastic MaterialsUSP <661> Packaging System Suitability for ExtractablesUSP <671> Stability and Buffering Capacity in Plastic ContainersUSP <800> Hazardous Drug Handling – Leachables from PackagingUSP <87> Biological Reactivity Test: In Vitro CytotoxicityUSP <88> Biological Reactivity Test: In Vivo Irritation & ToxicityUSP <905> Uniformity of Dosage Units – Leachable InfluenceWHO TRS 961 Annex 9 Guidelines on Packaging Materials – Leachables

USP <1079> Good Storage and Distribution Practices Leachable Risk Laboratory Testing Service

Provided by Eurolab: A Comprehensive Guide to Ensuring Product Safety and Reliability

USP <1079> Good Storage and Distribution Practices is a crucial standard that ensures the safety and efficacy of pharmaceutical products during storage and distribution. This standard outlines the practices and guidelines for maintaining the integrity of pharmaceuticals from the time they leave the manufacturer until they are received by the patient.

Relevant Standards

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

  • ASTM E2197-13 Standard Practice for Evaluating Extraction Resistance of Implantable Materials Packaging

  • EN ISO 10993-12:2009 Biological evaluation of medical devices Part 12: Sample preparation and reference materials

  • TSE (Turkish Standards Institution) TS EN ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes

    • International and National Standards

    The international standards that govern USP <1079> Good Storage and Distribution Practices are developed by organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), and European Committee for Standardization (CEN). These standards provide a framework for ensuring consistency and quality in storage and distribution practices.

    Standard Development Organizations

    Standards development organizations (SDOs) play a crucial role in developing and maintaining international and national standards. SDOs such as ISO, ASTM, and CEN are responsible for creating standards that ensure the safety and efficacy of pharmaceutical products.

    Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. New standards are developed or existing ones revised to address emerging concerns, improve performance, or enhance safety.

    Standard Numbers and Scope

    Some relevant standard numbers and their scope include:

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

    • Defines the classification of cleanroom environments based on air cleanliness levels

  • ASTM E2197-13 Standard Practice for Evaluating Extraction Resistance of Implantable Materials Packaging

    • Provides a method for evaluating the extraction resistance of implantable materials packaging

  • EN ISO 10993-12:2009 Biological evaluation of medical devices Part 12: Sample preparation and reference materials

    • Describes the requirements for sample preparation and reference materials in biological evaluations

    Standard Compliance Requirements

    Compliance with USP <1079> Good Storage and Distribution Practices is mandatory for pharmaceutical companies, contract manufacturing organizations (CMOs), and third-party logistics providers. Failure to comply can result in product recalls, regulatory fines, or even loss of market authorization.

    Standard-Related Information Conclusion

    USP <1079> Good Storage and Distribution Practices are governed by international and national standards developed by SDOs such as ISO, ASTM, and CEN. Compliance with these standards is crucial for ensuring the safety and efficacy of pharmaceutical products during storage and distribution.

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    Why USP <1079> Testing is Required

    USP <1079> Good Storage and Distribution Practices Leachable Risk testing is essential to ensure the integrity of pharmaceutical products. The consequences of not performing this test can be severe, including product recalls, regulatory fines, or even loss of market authorization.

    Business and Technical Reasons for Conducting USP <1079> Testing

    The business and technical reasons for conducting USP <1079> testing include:

  • Ensuring compliance with regulations and standards

  • Maintaining product quality and integrity

  • Preventing product recalls and regulatory fines

  • Protecting brand reputation and customer trust

    • Consequences of Not Performing USP <1079> Testing

    The consequences of not performing USP <1079> testing can be severe, including:

  • Product recalls due to contamination or degradation

  • Regulatory fines for non-compliance

  • Loss of market authorization due to quality issues

    • Industries and Sectors that Require USP <1079> Testing

    USP <1079> Good Storage and Distribution Practices Leachable Risk testing is required in various industries, including:

  • Pharmaceutical manufacturing

  • Biotechnology

  • Medical device industry

  • Cosmetics and personal care products

    • Risk Factors and Safety Implications

    The risk factors associated with USP <1079> testing include:

  • Contamination of pharmaceutical products during storage and distribution

  • Degradation of product quality due to inadequate storage conditions

  • Exposure to leachable substances from packaging materials

    • Quality Assurance and Quality Control Aspects

    USP <1079> Good Storage and Distribution Practices Leachable Risk testing involves rigorous quality assurance and quality control measures, including:

  • Validation of testing equipment and methods

  • Calibration of instruments and equipment

  • Documentation of test results and data

    • Standard Requirements and Needs Conclusion

    USP <1079> Good Storage and Distribution Practices Leachable Risk testing is essential for ensuring the safety and efficacy of pharmaceutical products during storage and distribution. Failure to perform this test can result in severe consequences, including product recalls, regulatory fines, or even loss of market authorization.

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    Please see above for Standard-Related Information.

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    Conclusion

    USP <1079> Good Storage and Distribution Practices Leachable Risk testing is a critical standard that ensures the safety and efficacy of pharmaceutical products during storage and distribution. Compliance with this standard is mandatory for pharmaceutical companies, CMOs, and third-party logistics providers. Failure to comply can result in product recalls, regulatory fines, or even loss of market authorization.

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    USP <1079> Good Storage and Distribution Practices Leachable Risk Testing Service

    Eurolab provides a comprehensive USP <1079> Good Storage and Distribution Practices Leachable Risk testing service that ensures compliance with regulations and standards. Our laboratory is equipped with state-of-the-art equipment and staffed by experienced professionals who are trained to perform USP <1079> testing.

    Service Overview

    Our USP <1079> Good Storage and Distribution Practices Leachable Risk testing service includes:

  • Sample preparation and handling

  • Extraction of leachable substances from packaging materials

  • Analysis of extracted substances using chromatography or mass spectrometry

  • Data interpretation and reporting

    • Benefits of Choosing Eurolabs Service

    By choosing our USP <1079> Good Storage and Distribution Practices Leachable Risk testing service, you can:

  • Ensure compliance with regulations and standards

  • Maintain product quality and integrity

  • Prevent product recalls and regulatory fines

  • Protect brand reputation and customer trust

    • Contact Us

    For more information about our USP <1079> Good Storage and Distribution Practices Leachable Risk testing service, please contact us at insert contact details.

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