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usp-62-test-for-specified-microorganisms-in-pharmaceutical-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 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 <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 <71> Sterility Test for Parenteral Drug Products

USP <62> Test for Specified Microorganisms in Pharmaceutical Products: Laboratory Testing Services

The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. This standard is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for the quality of pharmaceutical products.

Legal and Regulatory Framework

The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is governed by various laws and regulations, including:

  • The Federal Food, Drug, and Cosmetic Act (FDCA)

  • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • The European Unions Good Manufacturing Practice (GMP) guidelines

    • These regulations require pharmaceutical manufacturers to test their products for the presence of specified microorganisms.

    International and National Standards

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is based on international standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms)

  • ASTM E2197-10 (Standard test method for detection and enumeration of specified microorganisms in pharmaceutical products)

    • National standards also play a crucial role in ensuring compliance with regulations. For example, in the European Union, the GMP guidelines require manufacturers to comply with EU Directives 2003/94/EC and 2004/27/EC.

    Standard Development Organizations

    The development of standards for testing specified microorganisms in pharmaceutical products involves various organizations, including:

  • The United States Pharmacopeia (USP)

  • The International Organization for Standardization (ISO)

  • The American Society for Testing and Materials (ASTM)

    • These organizations work together to develop and publish standards that ensure consistency and accuracy in testing.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies become available. For example, the USP <62> Test for Specified Microorganisms in Pharmaceutical Products was updated in 2014 to include new methods for detecting microorganisms.

    Manufacturers must stay up-to-date with the latest standards to ensure compliance with regulations.

    Standard Numbers and Scope

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products has several standard numbers, including:

  • USP <62>

  • ISO 11133:2014

  • ASTM E2197-10

    • These standards cover the detection and enumeration of specified microorganisms in pharmaceutical products.

    Standard Compliance Requirements

    Compliance with standards is mandatory for manufacturers who want to sell their products in regulated markets. Manufacturers must demonstrate that their products meet the requirements of relevant standards.

    Manufacturers can obtain certification from accredited laboratories, such as Eurolab, to demonstrate compliance with standards.

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. This standard is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for the quality of pharmaceutical products.

    Legal and Regulatory Framework

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is governed by various laws and regulations, including:

  • The Federal Food, Drug, and Cosmetic Act (FDCA)

  • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • The European Unions Good Manufacturing Practice (GMP) guidelines

    • These regulations require pharmaceutical manufacturers to test their products for the presence of specified microorganisms.

    International and National Standards

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is based on international standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms)

  • ASTM E2197-10 (Standard test method for detection and enumeration of specified microorganisms in pharmaceutical products)

    • National standards also play a crucial role in ensuring compliance with regulations. For example, in the European Union, the GMP guidelines require manufacturers to comply with EU Directives 2003/94/EC and 2004/27/EC.

    Standard Development Organizations

    The development of standards for testing specified microorganisms in pharmaceutical products involves various organizations, including:

  • The United States Pharmacopeia (USP)

  • The International Organization for Standardization (ISO)

  • The American Society for Testing and Materials (ASTM)

    • These organizations work together to develop and publish standards that ensure consistency and accuracy in testing.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies become available. For example, the USP <62> Test for Specified Microorganisms in Pharmaceutical Products was updated in 2014 to include new methods for detecting microorganisms.

    Manufacturers must stay up-to-date with the latest standards to ensure compliance with regulations.

    Standard Numbers and Scope

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products has several standard numbers, including:

  • USP <62>

  • ISO 11133:2014

  • ASTM E2197-10

    • These standards cover the detection and enumeration of specified microorganisms in pharmaceutical products.

    Standard Compliance Requirements

    Compliance with standards is mandatory for manufacturers who want to sell their products in regulated markets. Manufacturers must demonstrate that their products meet the requirements of relevant standards.

    Manufacturers can obtain certification from accredited laboratories, such as Eurolab, to demonstrate compliance with standards.

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. This standard is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for the quality of pharmaceutical products.

    Legal and Regulatory Framework

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is governed by various laws and regulations, including:

  • The Federal Food, Drug, and Cosmetic Act (FDCA)

  • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • The European Unions Good Manufacturing Practice (GMP) guidelines

    • These regulations require pharmaceutical manufacturers to test their products for the presence of specified microorganisms.

    International and National Standards

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is based on international standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms)

  • ASTM E2197-10 (Standard test method for detection and enumeration of specified microorganisms in pharmaceutical products)

    • National standards also play a crucial role in ensuring compliance with regulations. For example, in the European Union, the GMP guidelines require manufacturers to comply with EU Directives 2003/94/EC and 2004/27/EC.

    Standard Development Organizations

    The development of standards for testing specified microorganisms in pharmaceutical products involves various organizations, including:

  • The United States Pharmacopeia (USP)

  • The International Organization for Standardization (ISO)

  • The American Society for Testing and Materials (ASTM)

    • These organizations work together to develop and publish standards that ensure consistency and accuracy in testing.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies become available. For example, the USP <62> Test for Specified Microorganisms in Pharmaceutical Products was updated in 2014 to include new methods for detecting microorganisms.

    Manufacturers must stay up-to-date with the latest standards to ensure compliance with regulations.

    Standard Numbers and Scope

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products has several standard numbers, including:

  • USP <62>

  • ISO 11133:2014

  • ASTM E2197-10

    • These standards cover the detection and enumeration of specified microorganisms in pharmaceutical products.

    Standard Compliance Requirements

    Compliance with standards is mandatory for manufacturers who want to sell their products in regulated markets. Manufacturers must demonstrate that their products meet the requirements of relevant standards.

    Manufacturers can obtain certification from accredited laboratories, such as Eurolab, to demonstrate compliance with standards.

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. This standard is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for the quality of pharmaceutical products.

    Legal and Regulatory Framework

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is governed by various laws and regulations, including:

  • The Federal Food, Drug, and Cosmetic Act (FDCA)

  • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002

  • The European Unions Good Manufacturing Practice (GMP) guidelines

    • These regulations require pharmaceutical manufacturers to test their products for the presence of specified microorganisms.

    International and National Standards

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is based on international standards, including:

  • ISO 11133:2014 (Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of microorganisms)

  • ASTM E2197-10 (Standard test method for detection and enumeration of specified microorganisms in pharmaceutical products)

    • National standards also play a crucial role in ensuring compliance with regulations. For example, in the European Union, the GMP guidelines require manufacturers to comply with EU Directives 2003/94/EC and 2004/27/EC.

    Standard Development Organizations

    The development of standards for testing specified microorganisms in pharmaceutical products involves various organizations, including:

  • The United States Pharmacopeia (USP)

  • The International Organization for Standardization (ISO)

  • The American Society for Testing and Materials (ASTM)

    • These organizations work together to develop and publish standards that ensure consistency and accuracy in testing.

    Standard Evolution and Updates

    Standards evolve over time as new technologies and methodologies become available. For example, the USP <62> Test for Specified Microorganisms in Pharmaceutical Products was updated in 2014 to include new methods for detecting microorganisms.

    Manufacturers must stay up-to-date with the latest standards to ensure compliance with regulations.

    Standard Numbers and Scope

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products has several standard numbers, including:

  • USP <62>

  • ISO 11133:2014

  • ASTM E2197-10

    • These standards cover the detection and enumeration of specified microorganisms in pharmaceutical products.

    Standard Compliance Requirements

    Compliance with standards is mandatory for manufacturers who want to sell their products in regulated markets. Manufacturers must demonstrate that their products meet the requirements of relevant standards.

    Manufacturers can obtain certification from accredited laboratories, such as Eurolab, to demonstrate compliance with standards.

     

    The USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. This standard is developed and published by the United States Pharmacopeia (USP), a non-profit organization that sets standards for the quality of pharmaceutical products.

     

    The standard requires manufacturers to test their products for the presence of specified microorganisms using methods such as plate counting, broth dilution, or PCR-based techniques. The results of these tests are used to determine whether the product meets the required specifications for purity and safety.

     

    Manufacturers must comply with regulations set by regulatory agencies such as the FDA and EMA. These regulations require manufacturers to demonstrate that their products meet certain standards for quality and safety.

     

    Compliance with standards is mandatory for manufacturers who want to sell their products in regulated markets. Manufacturers can obtain certification from accredited laboratories, such as Eurolab, to demonstrate compliance with standards.

     

    In conclusion, the USP <62> Test for Specified Microorganisms in Pharmaceutical Products is a widely accepted standard for testing pharmaceutical products for the presence of specified microorganisms. Compliance with this standard is mandatory for manufacturers who want to sell their products in regulated markets.

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