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fda-21-cfr-part-211-stability-testing-regulations
Stability and Compatibility Studies ASTM D1308 Chemical Resistance and Stability TestingASTM D4056 Compatibility Testing of Polymers in ProductsASTM D4065 Dynamic Mechanical Analysis for StabilityASTM D4332 Environmental Chamber Testing for StabilityASTM D618 Accelerated Aging and Stability Testing of PolymersASTM D6940 Stability Testing of Adhesive CosmeticsASTM E1309 Compatibility of Ingredients in FormulationsASTM E1447 Thermal Compatibility Testing of Cosmetic IngredientsASTM E1980 Accelerated Aging of Skin Care ProductsASTM E2169 Microbial Stability Testing of CosmeticsASTM E2243 Microbial Challenge Testing for StabilityASTM F1980 Accelerated Stability Testing of Medical DevicesEN ISO 11348 Luminescent Bacteria Test for Stability AnalysisEP 2.2.16 Determination of pH for Stability EvaluationEP 2.2.28 Determination of Residual Solvents in Stability SamplesEP 2.2.29 Water Determination for Stability SamplesEP 2.9.12 Determination of Viscosity for Stability TestingEP 5.1.5 Microbial Quality Control in Stability SamplesFDA Guidance for Stability Protocols in PharmaceuticalsFDA Guidance for Stability Testing of Topical ProductsFDA Guidance on Photostability Testing of ProductsFDA Guidance on Stability Testing in PharmaceuticalsICH Q1A(R2) Stability Testing of New Drug Substances and ProductsISO 10993-11 Toxicity Testing Related to Product StabilityISO 10993-17 Toxicological Risk Assessment for StabilityISO 10993-5 Cytotoxicity Testing for Stability AssessmentISO 10993-9 Biological Evaluation of Stability SamplesISO 11348-1 Luminescent Bacteria Test for StabilityISO 11607 Packaging Stability for Medical DevicesISO 11930 Preservative Effectiveness Testing in Stability StudiesISO 11987 Compatibility Testing of Plastics for StabilityISO 12732 Stability Testing of Personal Care ProductsISO 14502-1 Chemical Analysis of Cosmetics for StabilityISO 14516 Determination of Antioxidants in Stability StudiesISO 14644 Cleanroom Stability Conditions for ManufacturingISO 15193 Packaging Stability Testing of Personal Care ProductsISO 16128 Guidelines for Natural and Organic Cosmetic StabilityISO 16128-2 Calculation of Natural Content StabilityISO 16128-3 Natural Ingredients Stability AssessmentISO 16637 Compatibility Testing for Medical DevicesISO 16750 Environmental Conditions Testing for Electrical StabilityISO 16750-4 Electrical and Mechanical Stability TestingISO 17516 Microbial Quality Limits in StabilityISO 17516 Microbiological Limits for Stability StudiesISO 18852 Stability Testing of Textile TreatmentsISO 20252 Guidelines for Stability in Clinical InvestigationsISO 20252 Guidelines for Stability in Clinical TrialsISO 22514 Statistical Methods for Stability Data AnalysisISO 22514-2 Validation of Stability Testing MethodsISO 22611 Physical Compatibility Testing of Cosmetic ProductsISO 22716 GMP for Stability and Quality AssuranceISO 22716 Good Manufacturing Practices for StabilityISO 24367 Shelf Life and Stability Testing for CosmeticsISO/TR 10105 Evaluation of Cosmetic Product StabilityISO/TR 15961 Analytical Methods for Stability StudiesISO/TR 17399 Compatibility and Stability of Biocompatible MaterialsUSP <1086> Pharmaceutical Stability Validation ProceduresUSP <1220> Stability Testing of Drug ProductsUSP <1220> Stability Testing of Pharmaceuticals and CosmeticsUSP <1225> Validation of Stability-Indicating MethodsUSP <151> Stability Studies for Topical ProductsUSP <71> Sterility Testing for Stability StudiesUSP <71> Sterility Testing in Stability Protocols

Eurolabs FDA 21 CFR Part 211 Stability Testing Regulations Laboratory Testing Service

Eurolabs laboratory testing service for FDA 21 CFR Part 211 Stability Testing Regulations is governed by a range of international and national standards. The relevant standards include:

  • ISO 8502: General guidelines for the preparation of steel substrates before application of paints, varnishes, or other decorative coatings

  • ASTM D1238: Standard test method for melt flow rates of thermoplastics

  • EN ISO 175: Plastics - Determination of the effect of micro-organisms on the dimensional stability of plastics

  • TSE EN ISO 16775: Plastics - Determination of the effect of micro-organisms on the dimensional stability of plastics

    • These standards are developed by standard development organizations such as:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standards evolve over time to reflect new technologies, scientific breakthroughs, and changing regulatory requirements. For example, ISO 8502 has undergone several revisions since its initial publication in 1999.

    The scope of each standard is as follows:

  • ISO 8502: This standard provides general guidelines for the preparation of steel substrates before application of paints, varnishes, or other decorative coatings.

  • ASTM D1238: This standard describes the test method for melt flow rates of thermoplastics.

  • EN ISO 175: This standard determines the effect of micro-organisms on the dimensional stability of plastics.

  • TSE EN ISO 16775: This standard is a Turkish Standard based on the European Standard (EN) and International Standard (ISO).

    • The compliance requirements for different industries vary depending on factors such as product type, application, and geographical location.

    FDA 21 CFR Part 211 Stability Testing Regulations testing is required to ensure that pharmaceutical products maintain their quality and efficacy over time. This test is essential to ensure:

  • Product safety

  • Efficacy

  • Quality assurance

  • Regulatory compliance

  • Customer satisfaction

    • The consequences of not performing this test include:

  • Non-compliance with regulatory requirements

  • Loss of product efficacy or safety

  • Damage to brand reputation

  • Financial losses due to product recalls or rework

    • This testing is required for various industries, including pharmaceuticals, cosmetics, and food products. The risk factors associated with this testing include:

  • Product degradation over time

  • Chemical reactions

  • Microbial contamination

  • Physical changes in the product

    • The quality assurance and control aspects of this testing involve:

  • Sampling and preparation procedures

  • Testing equipment and instruments calibration

  • Data collection and recording procedures

  • Interpretation of test results

    • This test contributes to product safety and reliability by ensuring that products maintain their intended properties over time.

    The FDA 21 CFR Part 211 Stability Testing Regulations testing is conducted in accordance with the relevant standards. The step-by-step procedure for conducting this test involves:

    1. Sample preparation

    2. Testing equipment calibration

    3. Data collection and recording procedures

    4. Interpretation of test results

    The testing equipment used includes:

  • Temperature and humidity chambers

  • Incubators

  • Spectrophotometers

  • Microscopes

    • The testing environment requirements include:

  • Temperature range: 25C 5C (77F 9F)

  • Humidity range: 60 10

  • Pressure range: 1 atm 0.1 atm

    • The sample preparation procedures involve:

  • Sampling from the production batch

  • Preparation of test samples according to standard protocols

  • Labeling and packaging of test samples for storage and testing

    • The testing parameters and conditions include:

  • Storage conditions (temperature, humidity, pressure)

  • Testing duration (e.g., 6 months, 12 months)

    • The measurement and analysis methods involve:

  • Spectrophotometry

  • Microscopy

  • Chemical analysis

    • The calibration and validation procedures are performed regularly to ensure the accuracy of test results.

    The test results for FDA 21 CFR Part 211 Stability Testing Regulations testing are documented and reported in accordance with standard formats. The report format includes:

  • Test summary

  • Test conditions and parameters

  • Results interpretation

  • Conclusion and recommendations

    • The certification and accreditation aspects involve:

  • Documentation of the testing laboratorys credentials (e.g., ISO/IEC 17025)

  • Traceability of test samples to the production batch

    • The reporting standards and formats include:

  • Standardized report templates (e.g., PDF, Word)

  • Electronic reporting systems (e.g., online portals)

    • The results are validated and verified through a series of checks, including:

  • Review of raw data

  • Verification of calculations and results interpretation

  • Validation against established criteria

    • Conclusion

    Eurolabs laboratory testing service for FDA 21 CFR Part 211 Stability Testing Regulations ensures that products maintain their quality and efficacy over time. This test is essential to ensure product safety, efficacy, quality assurance, regulatory compliance, and customer satisfaction.

    The standard-related information, standard requirements and needs, test conditions and methodology, and test reporting and documentation aspects of this testing are outlined in this comprehensive guide.

    Eurolabs expertise and commitment to quality guarantee the accuracy and reliability of test results.

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

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