EUROLAB
ph-eur-518-microbiological-quality-of-herbal-preparations
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 ProductsTGA 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

Ph. Eur. 5.1.8 Microbiological Quality of Herbal Preparations Laboratory Testing Service: A Comprehensive Guide

The Ph. Eur. 5.1.8 Microbiological Quality of Herbal Preparations testing service is governed by various international and national standards that ensure the quality and safety of herbal preparations. The European Pharmacopoeia (Ph. Eur.) is a collection of standards for pharmaceutical substances, including microbiological quality control.

International Standards

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

  • ISO 15189:2012 - Medical laboratories Requirements for quality and competence

    • National Standards

  • EN 13645:2004 - Microbiological examination of herbal medicinal products and herbal substances

  • TSE (Turkish Standards Institution) 1321-2020 - Herbal medicinal products - Microbiological control

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE) are responsible for developing and maintaining these standards.

    Standard Evolution and Update

    Standards evolve to reflect advances in technology, changes in regulations, and new scientific discoveries. The update process involves:

    1. Review of existing standards

    2. Identification of gaps or limitations

    3. Development of new standards or revisions

    4. Publication and implementation

    Specific Standard Numbers and Scope

  • Ph. Eur. 5.1.8: Microbiological Quality of Herbal Preparations - Testing of the microbiological quality

  • ISO 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, production, storage and performance testing of culture media

    • Standard Compliance Requirements for Different Industries

    The requirements for standard compliance vary across industries:

  • Pharmaceutical industry: Ph. Eur. 5.1.8

  • Herbal medicine industry: EN 13645:2004

  • Cosmetics industry: ISO 11133:2014

  • Microbiological Quality of Herbal Preparations: The European Pharmacopoeia requires testing for the following microorganisms:

    • Total viable count (TVC)

    Yeast and moulds

    Salmonella

    Escherichia coli (E. coli)

    Clostridium botulinum

  • Herbal Preparations: Herbal preparations are defined as preparations of herbal origin, including extracts, which may be used in the manufacture of medicinal products

    • The Ph. Eur. 5.1.8 Microbiological Quality of Herbal Preparations testing service is essential for ensuring the quality and safety of herbal preparations.

    Why this specific test is needed and required

  • Product Safety: Testing for microbiological quality ensures that herbal preparations are safe for consumption.

  • Regulatory Compliance: Manufacturers must comply with Ph. Eur. 5.1.8 to ensure regulatory approval.

  • Consumer Protection: Testing prevents contamination and ensures the quality of herbal preparations.

    • Business and Technical Reasons

    The test is necessary due to:

  • Risk Assessment: Microbiological testing helps assess risks associated with contaminated products.

  • Quality Assurance: Regular testing ensures consistent product quality.

  • Market Access: Compliance with Ph. Eur. 5.1.8 facilitates international market access.

    • Consequences of Not Performing this Test

    Failure to conduct the test can lead to:

  • Regulatory Penalties

  • Product Recalls

  • Loss of Business Reputation

  • Financial Losses

    • Industries and Sectors Requiring this Testing

    The testing is required for:

  • Herbal medicine manufacturers

  • Pharmaceutical companies

  • Cosmetics industry

    • Risk Factors and Safety Implications

    The risk factors associated with microbiological contamination include:

  • Food Poisoning: Contaminated herbal preparations can cause food poisoning.

  • Product Recalls: Non-compliance can lead to product recalls, resulting in financial losses.

    • Quality Assurance and Quality Control Aspects

    Regular testing ensures:

  • Consistent Product Quality

  • Compliance with Regulations

  • Customer Confidence

    • Competitive Advantages of Having this Testing Performed

    Performing the test provides:

  • Market Differentiation: Compliance with Ph. Eur. 5.1.8 differentiates companies from competitors.

  • Increased Customer Trust: Regular testing builds customer confidence in product quality.

    • Cost-Benefit Analysis of Performing this Test

    The benefits of performing the test outweigh the costs, considering:

  • Regulatory Compliance

  • Product Safety

  • Customer Confidence

    • The Ph. Eur. 5.1.8 Microbiological Quality of Herbal Preparations testing service involves various laboratory procedures.

    Microbiological Examination

    The examination includes:

    1. Sample Preparation: Sample preparation for microbial analysis.

    2. Enumeration of Microorganisms: Enumeration of microorganisms, including total viable count (TVC), yeast and moulds, Salmonella, Escherichia coli (E. coli), and Clostridium botulinum.

    3. Detection of Contaminating Organisms: Detection of contaminating organisms.

    Laboratory Equipment and Materials

    The necessary equipment includes:

  • Microbiological analyzers

  • Incubators

  • Centrifuges

    • Standard Operating Procedures (SOPs)

    SOPs are essential for ensuring consistency in testing procedures, including:

    1. Sample Handling: Sample handling and storage.

    2. Microbiological Examination: Microbiological examination of samples.

    Testing Schedule

    Regular testing is essential to ensure compliance with Ph. Eur. 5.1.8, including:

  • Frequency of Testing: Regular testing at intervals not exceeding 12 months.

  • Sampling Plan: A sampling plan should be established to ensure representative sampling.

    • Reporting and Record Keeping

    Reports must include:

  • Testing Results: Microbiological examination results.

  • Conclusion: Conclusion on compliance with Ph. Eur. 5.1.8

  • Microbiological Quality Control: Regular microbiological quality control to ensure accurate testing.

  • Laboratory Accreditation: Laboratory accreditation is essential for ensuring competence in testing.

    • The Ph. Eur. 5.1.8 Microbiological Quality of Herbal Preparations testing service involves various international and national standards that ensure the quality and safety of herbal preparations.

    International Standards

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

  • ISO 15189:2012 - Medical laboratories Requirements for quality and competence

    • National Standards

  • EN 13645:2004 - Microbiological examination of herbal medicinal products and herbal substances

  • TSE (Turkish Standards Institution) 1321-2020 - Herbal medicinal products - Microbiological control

    • Standard Development Organizations

    The International Organization for Standardization (ISO), the European Committee for Standardization (CEN), and the Turkish Standards Institution (TSE) are responsible for developing and maintaining these standards.

    Standard Evolution and Update

    Standards evolve to reflect advances in technology, changes in regulations, and new scientific discoveries. The update process involves:

    1. Review of existing standards

    2. Identification of gaps or limitations

    3. Development of new standards or revisions

    4. Publication and implementation

    Specific Standard Numbers and Scope

  • Ph. Eur. 5.1.8: Microbiological Quality of Herbal Preparations - Testing of the microbiological quality

  • ISO 11133:2014 - Microbiology of food, animal feeding stuffs and pharmaceutical products Preparation, production, storage and performance testing of culture media

    • Standard Compliance Requirements for Different Industries

    The requirements for standard compliance vary across industries:

  • Pharmaceutical industry: Ph. Eur. 5.1.8

  • Herbal medicine industry: EN 13645:2004

  • Cosmetics industry: ISO 11133:2014

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