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fda-21-cfr-211113-contamination-prevention-procedures-for-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 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 AssessmentWHO Guidelines for the Microbiological Control of Herbal Cosmetics

Comprehensive Guide to FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics Testing Services

Standard-Related Information

The European laboratory Eurolab provides high-quality testing services for cosmetics laboratories worldwide. One of the essential testing services offered by Eurolab is the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing. This comprehensive guide aims to provide detailed information about this testing service, covering standard-related aspects, test requirements and needs, test conditions and methodology, test reporting and documentation, and why this test should be performed.

The FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is governed by various international and national standards. These standards ensure that the cosmetics industry adheres to strict guidelines to prevent contamination of products. The relevant standards include:

  • ISO/TS 16949:2016: This standard provides requirements for quality management systems for automotive suppliers.

  • ASTM E1509-18: This standard specifies a method for evaluating the effectiveness of a cleaning process in removing particulate contaminants from surfaces.

  • EN ISO 9001:2015: This standard outlines requirements for quality management systems (QMS) to ensure consistency and improvement in performance.

  • TSE/ISO 13485:2016: This standard specifies requirements for a QMS for medical device manufacturers.

    • Standard development organizations play a crucial role in creating, updating, and maintaining these standards. These organizations include:

  • International Organization for Standardization (ISO): ISO develops and publishes international standards.

  • American Society for Testing and Materials (ASTM): ASTM is responsible for developing and publishing technical standards for various industries.

  • European Committee for Standardization (CEN): CEN creates and publishes European standards.

    • Standards evolve over time due to advancements in technology, changes in regulatory requirements, or new industry needs. This ensures that the cosmetics industry remains compliant with current regulations and best practices.

    Relevant Standard Numbers and Scope

    Some of the relevant standard numbers and their scope include:

  • ISO 11133:2014: Microbiology of food and animal feeding stuffs Preparation of test samples, initial suspension, and decimal dilutions for microbiological examination.

  • ASTM E1513-18: Standard practice for sampling water from process systems in industrial processes.

    • Standard Compliance Requirements for Different Industries

    Different industries have varying standard compliance requirements. For example:

  • Cosmetics industry: The cosmetics industry must comply with the Good Manufacturing Practice (GMP) guidelines outlined by the FDA 21 CFR 211.113.

  • Pharmaceutical industry: The pharmaceutical industry must adhere to GMP guidelines as outlined in the FDA 21 CFR 211.

    • Standard-Related Information Conclusion

    In conclusion, the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is governed by various international and national standards. Understanding these standards is essential for ensuring compliance with regulatory requirements and maintaining product safety and reliability.

    The FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is an essential service required by the cosmetics industry to prevent contamination of products. This section will explain in detail why this specific test is needed and required, describe business and technical reasons for conducting the test, and outline consequences of not performing the test.

    Why This Test is Needed

    The FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is necessary to ensure that cosmetics products are safe for human use. The contamination prevention procedures outlined in this regulation aim to prevent microbial contamination, which can lead to product spoilage and consumer safety issues.

    Business and Technical Reasons for Conducting the Test

    The business and technical reasons for conducting the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing include:

  • Product Safety: The primary reason for conducting this test is to ensure that cosmetics products are safe for human use.

  • Compliance with Regulations: This test helps the cosmetics industry comply with regulatory requirements outlined in the FDA 21 CFR 211.113.

  • Quality Assurance and Control: Conducting this test ensures quality assurance and control within the manufacturing process.

    • Consequences of Not Performing the Test

    Failing to conduct the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing can lead to:

  • Product Recalls: Inadequate contamination prevention procedures can result in product recalls, which can damage brand reputation.

  • Financial Losses: Failure to comply with regulatory requirements can result in significant financial losses due to fines and penalties.

    • Industries and Sectors that Require this Testing

    The FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is required by various industries, including:

  • Cosmetics Industry: The cosmetics industry must adhere to the GMP guidelines outlined in the FDA 21 CFR 211.113.

  • Pharmaceutical Industry: The pharmaceutical industry must comply with GMP guidelines as outlined in the FDA 21 CFR 211.

    • Standard Requirements and Needs Conclusion

    In conclusion, the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is an essential service required by the cosmetics industry to prevent contamination of products. Understanding the reasons why this test is needed and the consequences of not performing it can help ensure compliance with regulatory requirements.

    This section will outline the test conditions and methodology used for conducting the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing.

    Test Conditions

    The test conditions for this service include:

  • Sampling: Eurolab collects representative samples from the cosmetics product.

  • Microbiological Testing: The collected samples are then subjected to microbiological testing using standard methods.

    • Methodology

    The methodology used for conducting this service includes:

  • Preparation of Test Samples: The test samples are prepared according to standard procedures outlined in ISO 11133:2014 and ASTM E1513-18.

  • Microbiological Testing: The prepared test samples are then subjected to microbiological testing using standard methods.

    • This section will outline the test reporting and documentation requirements for conducting the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing.

    Test Reporting

    The test report includes:

  • Introduction: A brief introduction to the test, including the purpose and scope.

  • Methods: A description of the methods used for conducting the test.

  • Results: The results obtained from the microbiological testing.

  • Conclusion: A conclusion outlining any findings or recommendations.

    • Documentation

    The documentation requirements include:

  • Test Report: A comprehensive report detailing the results of the test.

  • Certificate of Analysis (COA): A COA is provided for each sample tested, outlining the results obtained.

  • Chain-of-Custody: A chain-of-custody document is maintained to track the movement and storage of samples.

    • Why This Test Should be Performed

    In conclusion, conducting the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing is essential for ensuring compliance with regulatory requirements and maintaining product safety and reliability.

    Please note that this guide provides a general overview of the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing service offered by Eurolab. For specific information regarding your testing needs, please contact Eurolab directly.

    Additional Resources

    For further information about the FDA 21 CFR 211.113 Contamination Prevention Procedures for Cosmetics testing or to discuss your testing requirements, please visit our website at www.eurolab.com(http://www.eurolab.com) or contact us directly:

  • Phone: 1 (800) 123-4567

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

    • We look forward to assisting you with your testing needs.

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

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