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who-guidelines-for-the-microbiological-control-of-herbal-cosmetics
Microbiological Quality Testing AFNOR NF T73-101 Microbial Preservation Testing for CosmeticsANSM Challenge Testing of Natural Cosmetic FormulasANSM Microbiological Control of Non-Sterile Cosmetic ProductsANVISA RDC 481/2021 Microbial Control for Brazilian Cosmetic ProductsAOAC 2003.07 Challenge Test for Cosmetic CreamsAOAC 991.14 Microbial Contamination Detection in Personal Care ProductsAOAC 997.02 Microbial Quality of ToiletriesASTM D4014 Test for Microbial Growth on Lotions and CreamsASTM D5338 Biodegradation and Microbial Interaction in CosmeticsASTM D7983 Testing for Bacterial Endotoxins in Eye-area CosmeticsASTM E1326 Viable Organism Testing in Aerosolized Cosmetic ProductsASTM E2180 Antimicrobial Efficacy Testing of Preservative SystemsASTM E2275 Skin Antiseptic Residual Activity TestingASTM E2315 Time-Kill Assessment of Antimicrobial ActivityASTM E2613 Microbial Analysis of Water Used in CosmeticsASTM E2786 Biofilm Formation in Cosmetic Production EnvironmentsASTM E640 Bacterial Filtration in Cosmetic SpraysASTM F2101 Bacterial Filtration Efficiency of Cosmetic Face MasksCEN/TR 16953 Guidance on Application of ISO Microbial StandardsChina GB 7919 Microbial Limits in Non-Sterile CosmeticsChina GB/T 13531.1 Detection of E. coli in CosmeticsChina GB/T 13531.2 Detection of Pathogenic Bacteria in CosmeticsChina GB/T 13531.3 Microbial Limit in Baby ProductsCOLIPA Guideline for Preservation Efficacy TestingCOLIPA Microbiological Quality Assurance of Cosmetic ProductsEP 2.6.1 Sterility Test for Cosmetic Raw MaterialsEP 2.6.12 Total Aerobic Microbial Count TestingEP 2.6.13 Detection of Designated Microorganisms in CosmeticsEP 2.6.31 Validation of Microbiological Test Methods for CosmeticsEP 5.1.3 Evaluation of Preservative EffectivenessEP 5.1.4 Microbial Limits in Raw Cosmetic IngredientsEPA MB-17 Microbial Contamination Control in Natural FormulasFDA 21 CFR 211.113 Contamination Prevention Procedures for CosmeticsFDA 21 CFR 700.3 Microbial Contamination Limits in CosmeticsFDA BAM Chapter 14 Yeast and Mold Enumeration in Personal Care ProductsFDA BAM Chapter 23 Detection of Bacterial Pathogens in CosmeticsFDA CFSAN Guidelines for Cosmetic Microbiological SamplingFDA CPG Sec. 7120.01 Microbiological Criteria for Finished CosmeticsHealth Canada Compendial Test for Pathogenic Organisms in CosmeticsHealth Canada Cosmetic Microbiological Contamination GuidelinesIndia IS 14642 Microbial Contamination in Toiletries and SkincareIndia IS 4707-2 Cosmetic Ingredients Microbial AssessmentISO 11930 Microbiological Preservation Efficacy TestingISO 11932 Method Validation for Microbial Testing in CosmeticsISO 11989 Microbial Assessment of Eye CosmeticsISO 14502-2 Microbiological Testing of Polyphenol-Rich CosmeticsISO 16212 Quantification of Yeasts and Molds in Cosmetic ProductsISO 17516 Quantitative Limits of Microorganisms in Finished ProductsISO 18415 Detection of Specified and Non-Specified MicroorganismsISO 19007 Preservation Test of Microbial Resistance in Cosmetic WipesISO 21148 Detection of Anaerobic Bacteria in Cosmetic FormulationsISO 21149 Detection of Aerobic Mesophilic Bacteria in CosmeticsISO 21150 Detection of Escherichia coli in CosmeticsISO 22176 Hygiene Requirements in Cosmetic Packaging LinesISO 22716 Microbial Risk Management in GMP Cosmetic ManufacturingISO 22717 Identification of Pseudomonas aeruginosa in Cosmetic ProductsISO 22718 Identification of Staphylococcus aureus in CosmeticsISO 22719 Detection of Candida albicans in Cosmetic ProductsISO 24434 Enumeration of Aerobic Mesophilic Spores in Personal CareISO 24442 Selection Criteria for Challenge Test OrganismsISO 29621 Microbiological Risk Assessment for Low-Risk ProductsISO/TR 19838 Guidance on Risk Management for Cosmetic MicrobiologyISO/TR 24444 Comparison of Microbiological Test ProtocolsISO/TR 24475 Microbiological Assessment of Cosmetic Raw MaterialsISO/TR 24476 Test Method Selection for Cosmetic Product MicrobiologyISO/TS 29621 Categorization of Cosmetic Products Based on Microbiological RiskJIS K 5101 Preservative Efficiency in Japanese CosmeticsJIS L 1902 Evaluation of Antibacterial Activity of Cosmetic TextilesJIS Z 2801 Antimicrobial Efficacy Testing for Surfaces in Cosmetic FacilitiesKFDA Microbiological Safety Evaluation of Korean Cosmetic ProductsKFDA Testing for Microbial Contamination in Imported CosmeticsPh. Eur. 2.6.12 Total Count Test for EmulsionsPh. Eur. 2.6.13 Detection of Pathogens in Powdered CosmeticsSCCS/1564/15 Risk Assessment of Microbiological Contamination in CosmeticsSCCS/1611/19 Safety Levels of Microbial Contaminants in CosmeticsTS 13218 Total Bacteria Count in Cosmetic CreamsTS 13531 Bacterial Safety Testing of Shampoo ProductsTS EN 12353 Hygiene Control of Cosmetic Containers and ClosuresTS EN ISO 11930 Preservative Efficacy Test for Personal Care ProductsTS EN ISO 16212 Mold and Yeast Count in Cosmetic LiquidsTS EN ISO 18415 Detection of Transient Organisms in ToiletriesTS EN ISO 21148 Enumeration of Microorganisms in Cosmetic ProductsUSP <1227> Validation of Microbial Recovery in Cosmetic ProductsUSP <1231> Water Quality for Microbiological Control in Cosmetic ProductionUSP <2021> Microbial Control of Nutraceutical-Cosmetic HybridsUSP <2022> Evaluation of Cosmetic Quality Control ProtocolsUSP <51> Antimicrobial Effectiveness Testing (Preservative Challenge Test)USP <61> Microbial Enumeration Testing for Non-Sterile CosmeticsUSP <62> Testing for Specified Microorganisms in CosmeticsUSP <791> pH Control and Microbial Growth Assessment

Comprehensive Guide to WHO Guidelines for the Microbiological Control of Herbal Cosmetics Laboratory Testing Service Provided by Eurolab

The World Health Organization (WHO) has established guidelines for the microbiological control of herbal cosmetics, which is a crucial aspect of ensuring product safety and efficacy. These guidelines are based on international standards and regulations that govern laboratory testing.

Relevant Standards:

  • ISO 11133:2014 - Microbiology of food, animal feeding stuffs and beverages - Preparation, production, storage and performance testing of culture media
  • ASTM E2197-08(2020) - Standard Practice for Dry-Heat Sterilization of Medical and Surgical Items
  • EN ISO 11737-1:2009 - Sterility testing of medical devices - Part 1: Requirements for incorporated needs
  • TSE (Turkish Standards Institution) ISO/TS 11133:2014 - Microbiology of food, animal feeding stuffs and beverages - Preparation, production, storage and performance testing of culture media
  • International and National Standards:

    The WHO guidelines for the microbiological control of herbal cosmetics are based on international standards such as ISO, ASTM, and EN. These standards ensure that laboratory testing is conducted in accordance with established procedures and protocols.

    Standard Development Organizations:

  • International Organization for Standardization (ISO)
  • American Society for Testing and Materials (ASTM)
  • European Committee for Standardization (CEN)
  • These organizations play a crucial role in developing and maintaining international standards for laboratory testing.

    Standard Evolution and Update:

    Standards evolve over time to reflect advances in technology, new scientific discoveries, and changes in regulatory requirements. Laboratories must stay up-to-date with the latest standards to ensure compliance and maintain their reputation.

    Specific Standard Numbers and Scope:

  • ISO 11133:2014 - Preparation, production, storage and performance testing of culture media
  • ASTM E2197-08(2020) - Dry-heat sterilization of medical and surgical items
  • These standards are relevant to the microbiological control of herbal cosmetics laboratory testing.

    Standard Compliance Requirements:

    Laboratories must comply with relevant standards to ensure that their testing services meet international requirements. This includes:

  • Calibration and validation of equipment
  • Training and certification of personnel
  • Documented procedures for sample preparation, testing, and reporting
  • Industries Requiring this Testing:

    The WHO guidelines for the microbiological control of herbal cosmetics apply to various industries, including:

  • Cosmetics manufacturers
  • Herbal product suppliers
  • Pharmaceutical companies
  • These industries must ensure that their products meet international standards for safety and efficacy.

    Standard Compliance in Different Industries:

    Each industry has its specific compliance requirements for laboratory testing. For example:

  • Cosmetics manufacturers must comply with EU regulations (Cosmetics Regulation 1223/2009)
  • Herbal product suppliers must comply with WHO guidelines (WHO Guidelines for the Microbiological Control of Herbal Cosmetics)
  • Business and Technical Reasons for Conducting this Test:

    Conducting microbiological control testing ensures that herbal cosmetics products are safe for human use, reducing the risk of contamination and adverse reactions. This test is essential for:

  • Ensuring product safety
  • Maintaining regulatory compliance
  • Enhancing customer confidence
  • Consequences of Not Performing this Test:

    Failure to conduct microbiological control testing can result in:

  • Product recalls
  • Regulatory fines
  • Loss of customer trust
  • Quality Assurance and Quality Control Aspects:

    Laboratories must implement quality assurance and quality control measures to ensure that testing services meet international standards. This includes:

  • Calibration and validation of equipment
  • Training and certification of personnel
  • Documented procedures for sample preparation, testing, and reporting
  • Competitive Advantages:

    Conducting microbiological control testing provides a competitive advantage by:

  • Enhancing product safety
  • Improving regulatory compliance
  • Increasing customer confidence
  • Cost-Benefit Analysis:

    The cost-benefit analysis of conducting microbiological control testing is clear:

  • Ensuring product safety and regulatory compliance saves costs in the long run
  • Reducing the risk of contamination and adverse reactions increases customer satisfaction and loyalty
  • This section provides a detailed explanation of how the test is conducted, including:

  • Testing equipment and instruments used
  • Testing environment requirements
  • Sample preparation procedures
  • Testing parameters and conditions
  • Measurement and analysis methods
  • Calibration and validation procedures
  • Quality control measures during testing
  • Data collection and recording procedures
  • Testing timeframes and duration
  • Testing Equipment and Instruments:

    Laboratories must use calibrated and validated equipment to ensure accurate results. This includes:

  • Microbiological analyzers (e.g., spectrophotometers)
  • Incubators for microbial growth
  • Sterilizers for sample preparation
  • Testing Environment Requirements:

    The testing environment must meet specific requirements, including:

  • Temperature control ( 1C)
  • Humidity control ( 10)
  • Lighting control
  • Sample Preparation Procedures:

    Laboratories must follow documented procedures for sample preparation, including:

  • Sample collection and transportation
  • Sample storage and handling
  • Sample dilution and preparation
  • Testing Parameters and Conditions:

    The testing parameters and conditions must meet specific requirements, including:

  • Temperature (37C 2C)
  • Incubation time (18-24 hours)
  • Microbial growth medium (e.g., agar plates)
  • Measurement and Analysis Methods:

    Laboratories must use calibrated and validated equipment to ensure accurate results. This includes:

  • Spectrophotometry for microbial enumeration
  • PCR for DNA analysis
  • Calibration and Validation Procedures:

    Laboratories must implement calibration and validation procedures to ensure that equipment is functioning correctly.

    Quality Control Measures During Testing:

    Laboratories must implement quality control measures during testing, including:

  • Duplicate testing
  • Blinded samples
  • Inter-laboratory comparison
  • Data Collection and Recording Procedures:

    Laboratories must follow documented procedures for data collection and recording, including:

  • Electronic laboratory notebooks (ELNs)
  • Data management software
  • Testing Timeframes and Duration:

    The testing timeframe and duration vary depending on the specific test being conducted.

    Indicators of Contamination:

    The indicators of contamination include:

  • Bacterial growth
  • Fungal growth
  • Yeast growth
  • These indicators must be investigated and addressed to ensure product safety.

    Indicators of Non-Contamination:

    The indicators of non-contamination include:

  • Absence of microbial growth
  • Low microbial load (e.g., < 10 CFU/mL)
  • These indicators confirm that the product is safe for human use.

    Standard Operating Procedures (SOPs):

    Laboratories must develop and implement SOPs for microbiological control testing, including:

  • Sample preparation
  • Testing
  • Reporting
  • These SOPs ensure that testing services meet international standards.

    Training and Certification:

    Laboratory personnel must be trained and certified to conduct microbiological control testing. This includes:

  • Training on laboratory equipment
  • Training on testing procedures
  • Certification by a recognized organization (e.g., ISO/IEC 17025)
  • Calibration and Validation of Equipment:

    Equipment used for microbiological control testing must be calibrated and validated to ensure accuracy.

    Maintenance and Calibration Schedule:

    Laboratories must implement a maintenance and calibration schedule to ensure that equipment is functioning correctly.

    Indicators of Non-Conformity:

    The indicators of non-conformity include:

  • Inaccurate results
  • Incomplete or missing data
  • Non-compliance with SOPs
  • These indicators must be investigated and addressed to ensure product safety.

    Corrective Action Procedure:

    Laboratories must develop a corrective action procedure to address non-conformities, including:

  • Identifying root causes
  • Implementing corrective actions
  • Verifying effectiveness of corrective actions
  • This procedure ensures that non-conformities are addressed promptly and effectively.

    Reporting and Documentation Procedures:

    Laboratories must follow documented procedures for reporting and documentation, including:

  • Electronic laboratory notebooks (ELNs)
  • Data management software
  • These procedures ensure that data is accurately recorded and reported.

    Indicators of Compliance:

    The indicators of compliance include:

  • Accurate results
  • Complete or missing data
  • Compliance with SOPs
  • These indicators confirm that the product meets international standards for safety and efficacy.

    By following these guidelines, laboratories can ensure that microbiological control testing is conducted accurately and effectively, ensuring product safety and regulatory compliance.

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