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tga-tg-gmp-sterility-requirements-for-medicinal-products
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – RequirementsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

TGA TG-GMP Sterility Requirements for Medicinal Products Laboratory Testing Service: A Comprehensive Guide

Standard-Related Information

The TGA (Therapeutic Goods Administration) TG-GMP (Good Manufacturing Practice) sterility requirements for medicinal products laboratory testing service is governed by a range of international and national standards. These standards provide the framework for ensuring that medicinal products are safe, effective, and of high quality.

International Standards

  • ISO 11135:2009(E) - Sterilization of medical devices using ionizing radiation

  • ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes

  • ASTM E2500-18 - Standard Guide for Risk-Based Sampling in the Laboratory

    • National Standards

  • TGA TG-GMP Guidelines for the Manufacture of Medicinal Products

  • Australia/New Zealand Standard AS/NZS ISO 13485:2013 (Medical devices Quality management systems Requirements for regulatory purposes)

    • Standard Development Organizations

    The International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM) are two of the most prominent standard development organizations. These organizations bring together experts from around the world to develop standards that meet the needs of industry, governments, and consumers.

    Evolution of Standards

    Standards evolve over time as technology advances and new knowledge is gained. This ensures that laboratory testing services remain up-to-date with the latest methods and techniques.

    Standard Numbers and Scope

  • ISO 11135:2009(E) - Sterilization of medical devices using ionizing radiation

    • Scope: Provides requirements for the sterilization of medical devices using ionizing radiation

  • ASTM E2500-18 - Standard Guide for Risk-Based Sampling in the Laboratory

    • Scope: Provides guidance on risk-based sampling in laboratory testing

    Standard Compliance Requirements

    Compliance with standards is essential to ensure that medicinal products meet regulatory requirements. The following industries require compliance with TGA TG-GMP sterility requirements:

  • Pharmaceutical manufacturers

  • Biotechnology companies

  • Medical device manufacturers

  • Cosmetics and personal care product manufacturers

    • Consequences of Non-Compliance

    Failure to comply with TGA TG-GMP sterility requirements can result in serious consequences, including:

  • Product recalls

  • Regulatory fines and penalties

  • Loss of customer trust and reputation

  • Business closure or bankruptcy

    • Business and Technical Reasons for Conducting TGA TG-GMP Sterility Requirements Testing

    The business and technical reasons for conducting TGA TG-GMP sterility requirements testing include:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining customer trust and confidence

  • Improving competitiveness and market positioning

    • Standard Requirements and Needs

    The following are the standard requirements and needs for TGA TG-GMP sterility requirements testing:

  • Sterilization of medical devices using ionizing radiation (ISO 11135:2009(E))

  • Risk-based sampling in laboratory testing (ASTM E2500-18)

  • Quality management systems (AS/NZS ISO 13485:2013)

    • Test Conditions and Methodology

    The following are the test conditions and methodology for TGA TG-GMP sterility requirements testing:

  • Sterilization using ionizing radiation

  • Sample preparation procedures

  • Testing equipment and instruments used

  • Testing environment requirements

    • Test Reporting and Documentation

    The following are the test reporting and documentation requirements for TGA TG-GMP sterility requirements testing:

  • Test report format and structure

  • Interpretation of test results

  • Certification and accreditation aspects

  • Traceability and documentation requirements

    • Why This Test Should Be Performed

    The benefits of performing TGA TG-GMP sterility requirements testing include:

  • Ensuring product safety and efficacy

  • Meeting regulatory requirements

  • Maintaining customer trust and confidence

  • Improving competitiveness and market positioning

  • Reducing costs and improving efficiency

    • Why Eurolab Should Provide This Service

    Eurolab has the expertise, experience, and state-of-the-art equipment to provide high-quality TGA TG-GMP sterility requirements testing services. Our qualified and certified personnel ensure that all tests are performed in accordance with relevant standards.

    Additional Information

  • Industry-specific examples and case studies

  • Statistical data and research findings

  • Technical specifications and parameters

    • Conclusion

    TGA TG-GMP sterility requirements for medicinal products laboratory testing service is a critical aspect of ensuring product safety, efficacy, and regulatory compliance. Eurolabs expertise and experience make us the ideal partner for this testing service.

    References

    1. ISO 11135:2009(E) - Sterilization of medical devices using ionizing radiation

    2. ASTM E2500-18 - Standard Guide for Risk-Based Sampling in the Laboratory

    3. AS/NZS ISO 13485:2013 (Medical devices Quality management systems Requirements for regulatory purposes)

    4. TGA TG-GMP Guidelines for the Manufacture of Medicinal Products

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