EUROLAB
usp-2021-microbiological-testing-of-nutritional-and-dietary-supplements
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 PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <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

USP <2021> Microbiological Testing of Nutritional and Dietary Supplements: Laboratory Testing Services by Eurolab

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for the identity, strength, quality, and purity of substances used in pharmaceuticals, dietary supplements, and other healthcare products. The USP <2021> Microbiological Testing of Nutritional and Dietary Supplements standard provides guidelines for the microbiological testing of these products to ensure their safety and efficacy.

Relevant Standards and Regulations

  • USP <2021>: This standard outlines the requirements for microbiological testing of nutritional and dietary supplements.

  • ISO 17025: This international standard specifies the general requirements for laboratory competence, including sampling, testing, and calibration.

  • ASTM E2535-14: This American Society for Testing and Materials (ASTM) standard provides guidelines for the microbiological testing of dietary supplements.

  • EN 14342: This European Standard outlines the requirements for microbiological testing of herbal medicinal products.

    • International and National Standards

    The following standards apply to USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • ISO 17025:2005 (General requirements for laboratory competence)

  • ASTM E2535-14 (Microbiological testing of dietary supplements)

  • EN 14342 (Microbiological testing of herbal medicinal products)

    • Standard Development Organizations

    The following organizations are responsible for developing and maintaining standards related to microbiological testing:

  • United States Pharmacopeia (USP)

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards are regularly reviewed and updated to reflect new scientific knowledge, advances in technology, and changes in regulatory requirements. Manufacturers and testing laboratories must stay up-to-date with the latest standards and regulations to ensure compliance.

    Specific Standard Numbers and Scope

    The following standard numbers and scopes apply to USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • USP <2021>: Microbiological testing of nutritional and dietary supplements

  • ISO 17025: General requirements for laboratory competence

  • ASTM E2535-14: Microbiological testing of dietary supplements

    • Industry-Specific Standard Compliance Requirements

    The following industries require compliance with USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Dietary supplement manufacturers

  • Herbal medicinal product manufacturers

  • Cosmetics manufacturers (if they contain microbiologically active ingredients)

    • USP <2021> Microbiological Testing of Nutritional and Dietary Supplements is required to ensure the safety and efficacy of these products. The consequences of not performing this test can be severe, including:

  • Product contamination

  • Consumer harm or illness

  • Regulatory non-compliance

  • Loss of business reputation and revenue

    • Business and Technical Reasons for Conducting USP <2021> Microbiological Testing

    The following reasons support the need for conducting USP <2021> Microbiological Testing:

  • Product safety and efficacy: This test ensures that products are safe for consumption and effective.

  • Regulatory compliance: Compliance with standards is essential to avoid regulatory non-compliance.

  • Business reputation and revenue: Non-compliance can lead to loss of business reputation and revenue.

    • Consequences of Not Performing USP <2021> Microbiological Testing

    The consequences of not performing this test include:

  • Product contamination

  • Consumer harm or illness

  • Regulatory non-compliance

  • Loss of business reputation and revenue

    • Industries and Sectors that Require USP <2021> Microbiological Testing

    The following industries require compliance with USP <2021> Microbiological Testing:

  • Dietary supplement manufacturers

  • Herbal medicinal product manufacturers

  • Cosmetics manufacturers (if they contain microbiologically active ingredients)

    • Risk Factors and Safety Implications

    The following risk factors and safety implications support the need for conducting USP <2021> Microbiological Testing:

  • Microbial contamination: Contamination can lead to consumer harm or illness.

  • Regulatory non-compliance: Non-compliance can result in fines, penalties, and loss of business reputation and revenue.

    • Quality Assurance and Quality Control Aspects

    The following quality assurance and quality control aspects support the need for conducting USP <2021> Microbiological Testing:

  • Sampling and testing: This test ensures that products are safe for consumption and effective.

  • Calibration and validation: Calibration and validation ensure that equipment and methods used in testing are accurate and reliable.

    • Standard-Related Information Conclusion

    USP <2021> Microbiological Testing of Nutritional and Dietary Supplements is a critical standard for ensuring product safety, efficacy, regulatory compliance, business reputation, and revenue. Manufacturers and testing laboratories must stay up-to-date with the latest standards and regulations to ensure compliance.

    The following test methods are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Microbial enumeration: This method involves counting microorganisms present in a sample.

  • Microbial identification: This method involves identifying the type of microorganism present in a sample.

    • Sampling and Testing

    The following sampling and testing methods are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Random sampling: Random samples are taken from a batch or lot to ensure representative results.

  • Targeted sampling: Targeted samples are taken from a specific area or location within a batch or lot.

    • Calibration and Validation

    The following calibration and validation methods are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Equipment calibration: Equipment is calibrated to ensure accuracy and reliability.

  • Method validation: Methods are validated to ensure that they produce accurate and reliable results.

    • Test Method Validation

    The following test method validation methods are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Linearity: This method involves testing the linearity of a test method.

  • Precision: This method involves testing the precision of a test method.

    • Test Method Validation Conclusion

    USP <2021> Microbiological Testing of Nutritional and Dietary Supplements requires accurate and reliable results. Test methods must be validated to ensure that they produce accurate and reliable results.

    The following test results and reporting requirements apply to USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Raw data: Raw data is recorded and stored securely.

  • Test results: Test results are reported in a clear and concise manner.

    • Reporting Requirements

    The following reporting requirements apply to USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Summary report: A summary report is provided, detailing the test results.

  • Detailed report: A detailed report is provided, including raw data and test results.

    • Test Results Interpretation

    The following test results interpretation methods are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Pass/fail criteria: Test results are interpreted based on pass/fail criteria.

  • Action levels: Action levels are established to ensure that products meet regulatory requirements.

    • Test Results Reporting Conclusion

    USP <2021> Microbiological Testing of Nutritional and Dietary Supplements requires accurate and reliable reporting. Test results must be reported in a clear and concise manner, including raw data and test results.

    In conclusion, USP <2021> Microbiological Testing of Nutritional and Dietary Supplements is a critical standard for ensuring product safety, efficacy, regulatory compliance, business reputation, and revenue. Manufacturers and testing laboratories must stay up-to-date with the latest standards and regulations to ensure compliance.

    The following terms are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Microbial enumeration: The process of counting microorganisms present in a sample.

  • Microbial identification: The process of identifying the type of microorganism present in a sample.

  • Calibration: The process of adjusting equipment to ensure accuracy and reliability.

  • Validation: The process of verifying that a test method produces accurate and reliable results.

    • Glossary Conclusion

    The glossary provides definitions for terms used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements.

    The following references are used in USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • USP <2021>: Microbiological testing of nutritional and dietary supplements

  • ISO 17025: General requirements for laboratory competence

  • ASTM E2535-14: Microbiological testing of dietary supplements

    • References Conclusion

    The references provide additional information on USP <2021> Microbiological Testing of Nutritional and Dietary Supplements.

    The following appendix provides additional information on USP <2021> Microbiological Testing of Nutritional and Dietary Supplements:

  • Example protocols: Example protocols for microbiological testing.

  • Example reports: Example reports for microbiological testing.

    • Appendix Conclusion

    The appendix provides additional information on USP <2021> Microbiological Testing of Nutritional and Dietary Supplements.

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

    CONTACT US +902127020000

    Latest News

    View all

    Eurolab Successfully Renews ISO 17025 Accreditation

    Read More

    Expanded Cosmetic Safety Testing Portfolio Now Available at Eurolab

    Read More

    Eurolab Launches Technical Training Series for Industry Professionals

    Read More

    JOIN US
    Want to make a difference?

    Careers