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ep-61-real-time-stability-testing-of-biological-extracts
Stability Studies (ICH Guidelines) BP Appendix XVI Stability of Finished Products with PreservativesBP Stability Evaluation of Modified Release PreparationsEMA CHMP/QWP/609/2014 Quality Requirements for Stability of BiosimilarsEMA CPMP/QWP/122/02 Stability Testing for Transdermal PatchesEMA Guideline for Stability of Veterinary Medicinal ProductsEMA Guideline on Holding Times for Bulk Products (Stability Implication)EMA Guideline on Stability Testing for Liposomal Drug FormulationsEMA Guideline on Stability Testing for Orally Inhaled ProductsEMA Reflection Paper on Stability for Polymers in Drug DeliveryEMA Reflection Paper on Stability of Advanced Therapies (ATMPs)EMA Stability Testing for Nanoparticle FormulationsEMA Stability Testing in Pediatric FormulationsEMA Stability Testing of Drug-Device Combination ProductsEP 1.2.1 Drug Substance Stability in Multisource SubmissionsEP 2.9.5 Uniformity of Mass Post-Stability TestingEP 3.2.1 Container Closure System Stability EvaluationEP 5.20 Climatic Conditions in Stability Storage ChambersEP 6.0 Stability Testing Requirements for MonographsEP Climatic Zones IVa and IVb for ASEAN and African MarketsFDA 21 CFR 211.166 Stability Program Requirements for PharmaceuticalsFDA 21 CFR 610.17 Stability Testing of Biological ProductsFDA Accelerated Stability Protocol for Veterinary DrugsFDA cGMP Guidelines for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for Nutritional SupplementsFDA Guidance on Freeze-Thaw Stability Testing for BiologicsFDA Post-Approval Changes and Stability RequirementsFDA Q&A Guidance for Stability of Topical Dermatologic ProductsFDA Requirements for Drug Substance Holding Time & StabilityFDA Requirements for Orphan Drugs and Niche Stability StudiesICH E2E Pharmacovigilance & Stability Shelf-life ManagementICH E3 Stability Documentation in Clinical Study ReportsICH E6(R2) GCP Considerations in Clinical Trial Stability SamplesICH M10 Bioanalytical Method Validation in Stability TestingICH M4Q Stability Data Compilation for Common Technical Document (CTD)ICH M9 Stability of Biowaiver-Based Generic SubmissionsICH Q10 Pharmaceutical Quality System and Stability OversightICH Q11 Stability of Drug Substances in Developmental StagesICH Q12 Lifecycle Management and Ongoing Stability MonitoringICH Q14 Analytical Procedure Development in Stability StudiesICH Q1A(R2) Accelerated Stability Testing of Solid Oral Dosage FormsICH Q1B Photostability Testing for Light-Sensitive Drug ProductsICH Q1C Stability Testing for New Dosage Forms (Capsules, Tablets, etc.)ICH Q1D Bracketing and Matrixing Design Stability Protocol DevelopmentICH Q1E Evaluation of Stability Data for Regulatory SubmissionsICH Q1F Stability Data Requirements for Global RegistrationICH Q2(R1) Validation of Analytical Procedures in Stability StudiesICH Q3B(R2) Stability Testing of Impurities in Drug ProductsICH Q3C Residual Solvent Stability in Finished Dosage FormsICH Q4 Guidelines for Pharmacopoeial Stability HarmonizationICH Q4B Annex Stability-Related Harmonization for Global FilingICH Q5C Stability Testing of Biotechnological/Biological ProductsICH Q5D Derivation and Stability of Cell SubstratesICH Q6B Specifications Testing for Biotech Products in Long-Term StudiesICH Q8 Design Space for Stability-Critical ParametersICH Q9 Risk-Based Stability Planning and Protocol DesignICH S3B Photostability of Biologics in Animal StudiesICH S4 Stability of New Veterinary Drug Substances and ProductsICH S6(R1) Preclinical Stability of Biotech ProductsISO 10993-1 Biocompatibility Stability Studies in Medical DevicesISO 11607 Package Integrity Stability for Sterile Medical DevicesISO 13408 Stability Testing of Aseptic Processing SystemsISO 14644 Environmental Monitoring for Stability ChambersISO 14971 Risk Management Related to Stability FailuresISO 15378 GMP for Primary Packaging Stability InteractionsISO 17025 Stability Testing Accreditation RequirementsISO 17034 Reference Material Stability and HomogeneityISO 20387 Stability Assessment in Biobanking Sample StorageISO 21973 Transport Stability of Cell-Based TherapiesISO 9001:2015 Quality System Requirements for Stability ProgramsUSP <1046> Cellular and Gene Therapy Product StabilityUSP <1049> Excipient Stability and Shelf-Life EvaluationUSP <1079> Storage and Stability Testing in Distribution SystemsUSP <1086> Impurities Testing within Stability ProtocolsUSP <1090> Assessment of Drug Product Performance Post StabilityUSP <1118> Monitoring Stability in Storage and Transport ConditionsUSP <1168> Stability Testing for RadiopharmaceuticalsUSP <1191> Stability Considerations in Compounding Pharmacy ProductsUSP <1224> Transfer of Analytical Procedures in Stability StudiesUSP <1225> Validation of Compendial Procedures in Stability ContextUSP <1226> Verification of Compendial Procedures Post-StabilityUSP <671> Stability Testing of Packaging MaterialsUSP <795> Stability Evaluation of Nonsterile PreparationsUSP <797> Stability Testing of Sterile Preparations in CleanroomsWHO Annex 10 Stability Testing of Active Pharmaceutical IngredientsWHO Annex 7 Stability of Reconstituted Lyophilized ProductsWHO Annex 9 Stability for Zoonotic Biological ProductsWHO Good Storage and Distribution Practices for StabilityWHO Guidelines for Stability of DNA and mRNA VaccinesWHO Guidelines on Stability of Combination ARV TherapiesWHO Stability of Monoclonal Antibodies Under Accelerated ConditionsWHO Stability Requirements for Medical Oxygen and InhalersWHO Stability Testing for Pre-Filled Syringes and Auto-InjectorsWHO Temperature Mapping and Qualification of Stability ChambersWHO TRS 1003 Stability Protocols for Combination ProductsWHO TRS 1010 Stability Testing for Vaccines under Cold Chain ConditionsWHO TRS 1019 Stability Testing of Blood and Blood ProductsWHO TRS 953 Climatic Zone-Based Stability Testing for Global MarketsWHO TRS 970 Real-Time Stability Assessment for WHO PrequalificationWHO TRS 992 Long-Term Stability Testing for Herbal Medicinal Products

Comprehensive Guide to Eurolabs EP 6.1 Real-Time Stability Testing of Biological Extracts Laboratory Testing Service

EP 6.1 Real-Time Stability Testing of Biological Extracts is a laboratory testing service provided by Eurolab, governed by various international and national standards. The primary standard governing this testing service is ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

ISO 13485:2016

ISO 13485:2016 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) in the medical device industry. This standard is applicable to organizations involved in the design, development, production, installation, and maintenance of medical devices. The QMS is designed to ensure the consistent quality of medical devices and reduce the risk of nonconformity.

Other Relevant Standards

In addition to ISO 13485:2016, other relevant standards that govern EP 6.1 Real-Time Stability Testing of Biological Extracts testing include:

  • ASTM E2500-17: Standard Practice for Addressing the Needs of Users and Other Interested Parties in the Development of Standards

  • EN 12100:2009A1:2015: Medical devices - Quality management systems - Requirements for regulatory purposes

  • TSE (Turkish Standards Institution) 13229:2018: Quality Management Systems - Requirements for Regulatory Purposes

    • International and National Standards

    The international standards that apply to EP 6.1 Real-Time Stability Testing of Biological Extracts testing include:

  • ISO 13485:2016

  • ASTM E2500-17

  • EN 12100:2009A1:2015

    • National standards, such as TSE 13229:2018 in Turkey, may also be applicable.

    Standard Development Organizations and Their Role

    Standard development organizations (SDOs) play a crucial role in developing and maintaining international and national standards. The primary SDOs involved in the development of EP 6.1 Real-Time Stability Testing of Biological Extracts testing include:

  • International Organization for Standardization (ISO)

  • American Society for Testing and Materials (ASTM)

  • European Committee for Standardization (CEN)

    • Standard Evolution and Updates

    Standards evolve over time to reflect changes in technology, regulations, and industry practices. The process of updating standards involves the participation of stakeholders from various industries and countries.

    Specific Standard Numbers and Their Scope

    The specific standard numbers applicable to EP 6.1 Real-Time Stability Testing of Biological Extracts testing include:

  • ISO 13485:2016

  • ASTM E2500-17

  • EN 12100:2009A1:2015

    • These standards outline the requirements for a QMS in the medical device industry and provide guidelines for addressing user needs and regulatory requirements.

    Standard Compliance Requirements

    Compliance with relevant standards is mandatory for organizations involved in the design, development, production, installation, and maintenance of medical devices. Failure to comply can result in penalties, fines, or even recall of products.

    Industry-Specific Examples and Case Studies

  • A pharmaceutical company must comply with ISO 13485:2016 to ensure the consistent quality of their medical devices.

  • A medical device manufacturer must adhere to ASTM E2500-17 to address user needs and regulatory requirements.

  • A Turkish medical device company must conform to TSE 13229:2018 to meet national regulatory requirements.

    • Why This Specific Test is Needed

    EP 6.1 Real-Time Stability Testing of Biological Extracts is a critical testing service that ensures the stability and quality of biological extracts used in medical devices. The test is designed to simulate real-time conditions and evaluate the extracts performance over an extended period.

    Business and Technical Reasons for Conducting EP 6.1

    Conducting EP 6.1 Real-Time Stability Testing of Biological Extracts is essential for several business and technical reasons:

  • Ensures consistency and quality of biological extracts

  • Simulates real-time conditions to evaluate extract stability

  • Helps in identifying potential issues before product launch

  • Conforms to regulatory requirements and standards

    • Consequences of Not Performing This Test

    Failure to conduct EP 6.1 Real-Time Stability Testing of Biological Extracts can result in:

  • Substandard products that may cause harm to patients

  • Regulatory non-compliance and penalties

  • Loss of business reputation and trust

  • Delayed product launch or recall

    • Industries and Sectors That Require This Testing

    The following industries and sectors require EP 6.1 Real-Time Stability Testing of Biological Extracts:

  • Pharmaceutical industry

  • Medical device manufacturing

  • Biotechnology sector

  • Cosmetics industry

    • Risk Factors and Safety Implications

    EP 6.1 Real-Time Stability Testing of Biological Extracts is essential to identify potential risks associated with biological extracts, such as:

  • Contamination

  • Degradation

  • Instability

  • Toxicity

    • The safety implications of substandard biological extracts can be severe, resulting in harm to patients and damage to business reputation.

    Test Methodology and Equipment

    EP 6.1 Real-Time Stability Testing of Biological Extracts involves a combination of laboratory testing and equipment, including:

  • Spectrophotometry

  • High-performance liquid chromatography (HPLC)

  • Mass spectrometry (MS)

    • The test is designed to evaluate the extracts performance over an extended period under real-time conditions.

    Test Results and Interpretation

    EP 6.1 Real-Time Stability Testing of Biological Extracts provides critical data on the stability and quality of biological extracts, including:

  • Concentration

  • pH

  • Solubility

  • Activity

    • The test results are interpreted to ensure compliance with regulatory requirements and standards.

    Conclusion

    In conclusion, EP 6.1 Real-Time Stability Testing of Biological Extracts is a critical testing service that ensures the stability and quality of biological extracts used in medical devices. Compliance with relevant standards and regulations is mandatory for organizations involved in the design, development, production, installation, and maintenance of medical devices.

    The test methodology involves:

    1. Preparation of biological extract

    2. Measurement of initial concentration and pH

    3. Incubation under real-time conditions

    4. Spectrophotometry or HPLC-MS analysis to determine stability and quality

    The equipment used includes:

  • Spectrophotometer

  • HPLC system

  • MS analyzer

    • Interpretation of Test Results

    The test results are interpreted to ensure compliance with regulatory requirements and standards, including:

  • Concentration and pH levels

  • Stability and activity

  • Compliance with ISO 13485:2016 and other relevant standards

    • Conclusion

    In conclusion, EP 6.1 Real-Time Stability Testing of Biological Extracts is a critical testing service that ensures the stability and quality of biological extracts used in medical devices.

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