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iso-22716-good-manufacturing-practices-for-dermatological-products
Dermatological & Sensitivity Testing AFNOR BP X30-221 In Vivo Human Skin Testing ProceduresASTM D2979 Assessment of Skin Sensitization PotentialASTM D4236 Labeling of Cosmetic Products for Skin SafetyASTM D6125 Evaluation of Skin Sensitization Using In Vitro ModelsASTM D6977 Evaluation of Skin Contact AllergensASTM E1490 Evaluation of Allergic Contact DermatitisASTM E2711 Human Repeat Insult Patch Test (HRIPT) with Extended ProtocolASTM E2753 Human Repeat Insult Patch Test (HRIPT)ASTM F2312 Evaluation of Patch Test Allergen ReleaseCOLIPA Guidelines for Skin Compatibility TestingEN 16820 Test Method for Skin Sensitization PotentialEN 1811 Determination of Nickel Release from Skin-Contact ProductsEN ISO 10993-10 Assessment of Skin IrritationEN ISO 10993-18 Chemical Characterization for Dermal SafetyEN ISO 10993-21 Evaluation of Skin Irritation from Medical Device ExtractsEN ISO 10993-5 Cytotoxicity Testing on Skin CellsEP 5.1.6 Evaluation of Dermatological Safety of CosmeticsFDA 21 CFR 820 Quality System Regulation for Dermal DevicesFDA 21 CFR Part 807 Sensitivity Testing of Topical ProductsFDA Guidance for Dermatological Testing of Topical ProductsFDA Guidance on Dermal Sensitization Risk AssessmentISO 105-A02 Colorfastness to Artificial Light on SkinISO 10993-1 Biological Evaluation of Medical Devices - Dermal AspectsISO 10993-10 Evaluation of Skin Irritation and SensitizationISO 10993-11 Toxicity Testing Related to Skin ContactISO 10993-12 Sample Preparation for Dermal TestingISO 10993-16 Toxicokinetic Testing of Substances in Dermal ExposureISO 10993-17 Toxicological Risk Assessment for Dermal ProductsISO 10993-19 Evaluation of Allergic Contact Dermatitis in Skin ProductsISO 10993-20 Dermal Toxicology Testing MethodsISO 10993-22 Evaluation of Sensitization from Skin Contact DevicesISO 10993-23 Evaluation of Phototoxicity and PhotoallergyISO 11137 Sterilization Validation of Dermal DevicesISO 11930 Preservative Effectiveness for Sensitive Skin ProductsISO 14155 Clinical Investigation of Medical Devices on SkinISO 15223-1 Symbols for Dermal Medical DevicesISO 15223-1 Symbols for Indicating Skin Contact in Medical DevicesISO 16128 Guidelines on Natural and Organic Cosmetic IngredientsISO 16128-1 Guidelines on Natural and Organic Cosmetics Part 1ISO 16128-2 Calculation of Natural Ingredient Content in Skin ProductsISO 16128-3 Methodologies for Determining Organic Content in Skin CareISO 16134 Human Repeat Insult Patch Test GuidanceISO 16134-2 Guidance for Patch Test Interpretation in Skin TestingISO 17516 Microbiological Limits for Skin ProductsISO 21404 Testing for Skin Contact AllergensISO 21486 Risk Assessment for Skin Contact MaterialsISO 22444 Measurement of Skin Moisture ContentISO 22715 Labeling Requirements for Skin and Cosmetic ProductsISO 22716-1 Good Manufacturing Practices for Skin Care ProductsISO 23975 Patch Test Protocols for Dermatological ProductsISO 24441 In Vitro Determination of Sun Protection Factor (SPF)ISO 24442 Evaluation of Human Skin Irritation PotentialISO 24443 In Vitro Assessment of Sunscreen Efficacy on SkinISO 24443 In Vitro SPF Testing for SunscreensISO 24443 In Vitro UV Protection Factor Testing for SunscreensISO 24443 UV Protection Testing for Sensitive Skin FormulationsISO 3160-2 Compression Testing on Skin Contact MaterialsISO 3175-4 Analysis of Volatile Components Affecting Skin SensitivityISO 8124-6 Safety Requirements for Toys Affecting SkinISO/TR 16181 Guidelines on Skin Compatibility of CosmeticsISO/TR 16271 Guidelines on Safety Assessment for Skin Contact MaterialsISO/TR 19218 Dermatological Safety Data ManagementISO/TR 19930 Development of Dermal Sensitization AssaysISO/TR 22219 Testing of Skin Barrier FunctionISO/TR 29622 Allergens in Cosmetics and Personal Care ProductsJIS K 5600-5-7 Patch Test Methods for Skin SensitivityOECD TG 405 Acute Dermal Irritation/Corrosion TestOECD TG 406 Skin Sensitization in AnimalsOECD TG 406 Skin Sensitization Testing in AnimalsOECD TG 437 Bovine Corneal Opacity and Permeability Test for Skin SafetyOECD TG 439 In Vitro Skin Irritation Testing for CosmeticsOECD TG 442B Local Lymph Node Assay for Skin SensitizationOECD TG 442C In Chemico Skin Sensitization Assay (DPRA)OECD TG 442D In Vitro Skin Sensitization Assay (KeratinoSens™)OECD TG 442E Human Cell Line Activation Test (h-CLAT) for Skin SensitizationOECD TG 442E In Vitro Skin Sensitization Assay (h-CLAT)USP <151> Evaluation of Skin Irritation for Topical Dosage FormsUSP <151> Skin Sensitization Studies in Pharmaceuticals

Comprehensive Guide to ISO 22716 Good Manufacturing Practices for Dermatological Products Laboratory Testing Service Provided by Eurolab

ISO 22716 is an international standard that outlines the good manufacturing practices (GMP) for dermatological products. This standard aims to ensure that these products are manufactured in a way that meets the requirements of quality, safety, and efficacy.

The ISO 22716 standard is developed by the International Organization for Standardization (ISO), which is a non-governmental organization that develops and publishes international standards for various industries. The standard is also aligned with other relevant standards such as EN 14619, ASTM E 2450-11, and TSE IEC 60601.

The legal and regulatory framework surrounding this testing service is governed by various laws and regulations at the national and international levels. For example, in the European Union (EU), the Cosmetics Regulation (EC) No. 1223/2009 requires that cosmetics products, including dermatological products, comply with GMP principles. Similarly, in the United States (US), the FDAs Good Manufacturing Practice regulation (21 CFR Part 211) governs the manufacturing of pharmaceutical and cosmetic products.

Internationally, standards such as ISO 22716 are used to ensure that products meet specific requirements for quality, safety, and efficacy. These standards also provide a framework for companies to demonstrate their commitment to quality and compliance with regulatory requirements.

Standard development organizations (SDOs) play a crucial role in the development of international standards like ISO 22716. SDOs such as ISO, ASTM, EN, and TSE bring together experts from various industries to develop and maintain standards that meet the needs of industry stakeholders.

Standards evolve over time to reflect changes in technology, regulatory requirements, or industry practices. New editions of standards may include updates to existing requirements or introduce new requirements. For example, the ISO 22716 standard has undergone several revisions since its initial publication in 2006.

The following are some specific standard numbers and their scope:

  • ISO 22716:2012 - Good manufacturing practice (GMP) for dermatological products

  • EN 14619:2014 - Cosmetics - Safety assessment of fragrance ingredients

  • ASTM E 2450-11 - Standard Guide for Evaluating the Stability of Cosmetics

    • Standard compliance is a requirement for many industries, including cosmetics and pharmaceuticals. Companies that manufacture or import these products must comply with relevant standards to ensure that their products meet quality, safety, and efficacy requirements.

    Standards Compliance Requirements

  • EU: Cosmetic Regulation (EC) No. 1223/2009

  • US: FDAs Good Manufacturing Practice regulation (21 CFR Part 211)

  • International: ISO 22716, EN 14619, ASTM E 2450-11

    • Standard-Related Information Table

    Standard Number Title Scope

    --- --- ---

    ISO 22716:2012 Good manufacturing practice (GMP) for dermatological products Manufacturing of dermatological products

    EN 14619:2014 Cosmetics - Safety assessment of fragrance ingredients Safety evaluation of fragrance ingredients in cosmetics

    ASTM E 2450-11 Standard Guide for Evaluating the Stability of Cosmetics Evaluation of cosmetic stability

    The ISO 22716 standard is essential for ensuring that dermatological products meet quality, safety, and efficacy requirements. This testing service is required to ensure that products are manufactured in a way that meets regulatory requirements.

    Business and technical reasons for conducting this test include:

  • Ensuring product quality and safety

  • Complying with regulatory requirements

  • Protecting public health

  • Maintaining customer trust

    • The consequences of not performing this test can be severe, including:

  • Product recalls or withdrawals from the market

  • Financial losses due to regulatory non-compliance

  • Damage to brand reputation and customer trust

    • Industries that require this testing include:

  • Cosmetics and personal care products

  • Pharmaceuticals

  • Medical devices

  • Food industry

    • Risk factors and safety implications of not conducting this test include:

  • Product contamination or adulteration

  • Safety risks for consumers

  • Regulatory non-compliance

  • Financial losses

    • Quality assurance and quality control aspects of this testing service include:

  • Ensuring compliance with regulatory requirements

  • Maintaining product quality and safety standards

  • Implementing effective quality management systems (QMS)

  • Continuously monitoring and improving manufacturing processes

    • This test contributes to product safety and reliability by ensuring that products meet regulatory requirements, maintaining public health, and protecting consumer interests.

    Competitive Advantages

    Performing this testing service can provide several competitive advantages, including:

  • Increased customer confidence and trust

  • Improved brand reputation

  • Enhanced market access and trade facilitation

  • Reduced regulatory risks

    • Cost-benefit analysis of performing this test shows that the benefits outweigh the costs. Companies that invest in this testing service can expect to see improved product quality, reduced regulatory risks, and enhanced brand reputation.

    Competitive Advantages Table

    Competitive Advantage Description

    --- ---

    Increased customer confidence and trust Improved brand reputation

    Enhanced market access and trade facilitation Reduced regulatory risks

    Standards Compliance Requirements for Dermatological Products

  • EU: Cosmetic Regulation (EC) No. 1223/2009

  • US: FDAs Good Manufacturing Practice regulation (21 CFR Part 211)

  • International: ISO 22716

    • Standard-Related Information Table

    Standard Number Title Scope

    --- --- ---

    ISO 22716:2012 Good manufacturing practice (GMP) for dermatological products Manufacturing of dermatological products

    Standards Compliance Requirements Table

    Regulatory Requirement Description

    --- ---

    EU Cosmetic Regulation (EC) No. 1223/2009 Ensures compliance with GMP principles in cosmetics manufacturing

    FDAs Good Manufacturing Practice regulation (21 CFR Part 211) Regulates the manufacturing of pharmaceutical and cosmetic products

    Standards Compliance Requirements for Cosmetics

  • EU: Cosmetic Regulation (EC) No. 1223/2009

  • US: FDAs Good Manufacturing Practice regulation (21 CFR Part 211)

  • International: ISO 22716

    • This concludes the standard-related information section.

    Standard-Related Information Summary Table

    Standard Number Title Scope

    --- --- ---

    ISO 22716:2012 Good manufacturing practice (GMP) for dermatological products Manufacturing of dermatological products

    EN 14619:2014 Cosmetics - Safety assessment of fragrance ingredients Safety evaluation of fragrance ingredients in cosmetics

    ASTM E 2450-11 Standard Guide for Evaluating the Stability of Cosmetics Evaluation of cosmetic stability

    Standards Compliance Requirements Summary Table

    Regulatory Requirement Description

    --- ---

    EU Cosmetic Regulation (EC) No. 1223/2009 Ensures compliance with GMP principles in cosmetics manufacturing

    FDAs Good Manufacturing Practice regulation (21 CFR Part 211) Regulates the manufacturing of pharmaceutical and cosmetic products

    Next Section: Standard-Related Information

    The next section will discuss the standard-related information, including the purpose, scope, and application of the ISO 22716 standard.

    Please let me know if you would like to proceed with the next section or make any changes to this document.

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