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21-cfr-part-211167-special-testing-requirements
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for DistributionAOAC 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 <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to 21 CFR Part 211.167 Special Testing Requirements Laboratory Testing Service by Eurolab

21 CFR Part 211.167 Special Testing Requirements is a regulation set forth by the United States Food and Drug Administration (FDA) that governs laboratory testing for pharmaceutical, biotechnology, and medical device industries. This section outlines the requirements for special testing, including tests not specified in 21 CFR Part 211.160(b), such as water quality testing, microbiological testing, and chemical analysis.

Relevant Standards

The following international and national standards apply to this specific laboratory test:

  • ISO/IEC 17025:2017 (General requirements for the competence of testing and calibration laboratories)

  • ASTM E3008-16 (Standard Practice for Evaluation of Analytical Methods for Testing Biological Materials)

  • EN 14518:2009 (Biological indication of satisfactory performance of materials intended to come into contact with biological fluids)

    • International and National Standards

    The International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM) are two major standard development organizations that play a significant role in governing laboratory testing. The European Committee for Standardization (CEN) also contributes to standard development.

    Standard Development Organizations

  • ISO: Develops standards for testing and calibration laboratories, including general requirements for competence.

  • ASTM: Develops standards for various industries, including pharmaceutical, biotechnology, and medical device.

  • CEN: Develops European standards, including those related to laboratory testing.

    • Evolution of Standards

    Standards evolve over time as technology advances and new methods are developed. Regular updates ensure that standards remain relevant and effective in governing laboratory testing.

    Specific Standard Numbers and Scope

    Some specific standard numbers and their scope include:

  • ISO/IEC 17025:2017 - General requirements for the competence of testing and calibration laboratories

    • Scope: Applies to all types of testing, including chemical analysis, microbiological testing, and water quality testing.

  • ASTM E3008-16 - Standard Practice for Evaluation of Analytical Methods for Testing Biological Materials

    • Scope: Applies to biological materials testing, including pharmaceutical and biotechnology products.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for industries subject to 21 CFR Part 211.167 Special Testing Requirements. Non-compliance can result in regulatory non-compliance issues, fines, and reputational damage.

    Industries and Sectors Requiring This Testing

    Pharmaceutical, biotechnology, medical device, food, cosmetics, and chemical industries require laboratory testing for compliance with regulations and standards.

    Consequences of Not Performing This Test

    Non-compliance with 21 CFR Part 211.167 Special Testing Requirements can lead to regulatory action, product recalls, and damage to a companys reputation.

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    Why This Specific Test is Needed and Required

    This test is necessary for ensuring the quality, safety, and efficacy of pharmaceuticals, biotechnology products, and medical devices. Laboratory testing is essential for verifying compliance with regulations and standards.

    Business and Technical Reasons for Conducting 21 CFR Part 211.167 Special Testing Requirements Testing

  • Ensures product quality and safety

  • Compliance with regulations and standards

  • Verifies the efficacy of pharmaceuticals and biotechnology products

  • Prevents regulatory non-compliance issues

    • Consequences of Not Performing This Test

    Non-compliance can result in:

  • Regulatory action, fines, and reputational damage

  • Product recalls and market withdrawal

  • Damage to a companys reputation and customer trust

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    Detailed Step-by-Step Explanation of How the Test is Conducted

    1. Sample preparation: Collect and prepare samples according to standard procedures.

    2. Testing equipment and instruments: Use calibrated and validated testing equipment, such as spectrophotometers and chromatographs.

    3. Testing environment requirements:

    Temperature: 20C 5C

    Humidity: 50 10

    Pressure: Atmospheric pressure

    4. Measurement and analysis methods: Perform measurements according to standard procedures and analyze data using statistical software.

    Testing Parameters and Conditions

  • Sampling frequency: At least once per shift for continuous processes.

  • Testing parameters: pH, conductivity, microbial count, and chemical analysis.

  • Test method: Standard methods, such as ASTM E3008-16 or ISO 9001:2015.

    • Calibration and Validation Procedures

  • Calibration: Conduct regular calibration of testing equipment according to standard procedures.

  • Validation: Validate test methods against reference materials and standards.

    • ---

    How Test Results are Documented and Reported

    1. Report format: Use a clear, concise, and structured report format.

    2. Data collection and recording: Record data in real-time using electronic systems.

    3. Review and approval: Review and approve reports before release.

    Example of a Standardized Test Report Format

  • Introduction

  • Materials and methods

  • Results

  • Discussion

  • Conclusion

    • ---

    Conclusion

    21 CFR Part 211.167 Special Testing Requirements laboratory testing is essential for ensuring product quality, safety, and efficacy in pharmaceuticals, biotechnology products, and medical devices. Compliance with regulations and standards requires regular updates to testing procedures and equipment.

    Eurolabs expertise in laboratory testing can help you ensure compliance with regulatory requirements. Our team of experienced scientists and technicians will guide you through the process, ensuring that your products meet the highest quality and safety standards.

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    References

  • 21 CFR Part 211.167 Special Testing Requirements

  • ISO/IEC 17025:2017 (General requirements for the competence of testing and calibration laboratories)

  • ASTM E3008-16 (Standard Practice for Evaluation of Analytical Methods for Testing Biological Materials)

  • EN 14518:2009 (Biological indication of satisfactory performance of materials intended to come into contact with biological fluids)

    • About Eurolab

    Eurolab is a leading provider of laboratory testing services, specializing in pharmaceuticals, biotechnology products, and medical devices. Our team of experts ensures compliance with regulatory requirements and standards.

    Contact us today to learn more about our laboratory testing services:

    Email: infoeurolab.com(mailto:infoeurolab.com)

    Phone: 1 (800) 123-4567

    Address: 123 Main Street, Anytown, USA

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    Contact us for prompt assistance and solutions.

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