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who-annex-7-stability-of-reconstituted-lyophilized-products
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 6.1 Real-Time Stability Testing of Biological ExtractsEP 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for Expiration Dating and Stability StudiesFDA Container Closure Stability Evaluation for Ophthalmic ProductsFDA Draft Guidance for Stability of Inhaled Cannabis ProductsFDA Draft Guidance on Cannabis Stability Testing in Drug DevelopmentFDA Guidance for Allergenic Products Stability AssessmentFDA Guidance for Industry: Stability Testing for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 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 WHO Annex 7 Stability of Reconstituted Lyophilized Products Laboratory Testing Service Provided by Eurolab

The WHO Annex 7 Stability of Reconstituted Lyophilized Products testing service is governed by a set of international and national standards that ensure the safety, quality, and efficacy of pharmaceutical products. The relevant standards include:

  • ISO 9001:2015 Quality Management System

  • ASTM E2500-17 Standard Guide for Conducting Ruggedness Testing of Analytical Methods

  • EN 14698:2009A1:2014 Pharmaceutical dosage forms - Quality control

  • TSE (Turkish Standards Institution) TS 13415:2017 Pharmaceutical dosage forms - Stability testing

    • These standards are developed and published by standard development organizations such as the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), European Committee for Standardization (CEN), and Turkish Standards Institution (TSE).

    Standard development organizations play a crucial role in ensuring that standards are up-to-date, relevant, and applicable to the needs of industries. The evolution of standards is an ongoing process, with new standards being developed, revised, or withdrawn as needed.

    The scope of these standards includes:

  • ISO 9001:2015 Quality Management System: Provides a framework for organizations to establish a quality management system that meets customer and regulatory requirements.

  • ASTM E2500-17 Standard Guide for Conducting Ruggedness Testing of Analytical Methods: Offers guidelines for conducting ruggedness testing of analytical methods, including stability testing of reconstituted lyophilized products.

  • EN 14698:2009A1:2014 Pharmaceutical dosage forms - Quality control: Specifies the requirements for quality control of pharmaceutical dosage forms, including stability testing.

  • TSE TS 13415:2017 Pharmaceutical dosage forms - Stability testing: Describes the requirements for stability testing of pharmaceutical dosage forms.

    • These standards are applicable to various industries, including:

  • Pharmaceuticals and biotechnology

  • Cosmetics and personal care products

  • Food and beverage industry

    • Compliance with these standards is mandatory for organizations that want to ensure the quality, safety, and efficacy of their products. Non-compliance can lead to regulatory issues, fines, and even product recalls.

    The WHO Annex 7 Stability of Reconstituted Lyophilized Products testing service is essential for ensuring the stability and shelf-life of pharmaceutical products. The business and technical reasons for conducting this test include:

  • Ensuring product quality and safety

  • Complying with regulatory requirements

  • Protecting consumers from potential harm

  • Maintaining market share and competitiveness

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

  • Regulatory non-compliance

  • Product recalls and withdrawals

  • Damage to brand reputation

  • Financial losses due to wasted resources and lost sales

    • Industries that require this testing include:

  • Pharmaceuticals and biotechnology

  • Cosmetics and personal care products

  • Food and beverage industry

    • The risk factors associated with reconstituted lyophilized products include:

  • Instability of the product over time

  • Loss of potency or efficacy

  • Contamination or adulteration

  • Poor manufacturing practices

    • Quality assurance and quality control aspects are crucial in ensuring the accuracy and reliability of this testing service. The test contributes to product safety and reliability by:

  • Ensuring that products meet regulatory requirements

  • Protecting consumers from potential harm

  • Maintaining market share and competitiveness

    • The competitive advantages of having this testing performed include:

  • Improved product quality and safety

  • Enhanced brand reputation

  • Increased customer confidence and trust

  • Regulatory compliance benefits

    • The cost-benefit analysis of performing this test is as follows:

  • Cost: 5,000 - 10,000 per test (depending on the scope and complexity)

  • Benefits:

    • Regulatory compliance savings

    Reduced risk of product recalls and withdrawals

    Improved brand reputation and customer confidence

    Increased market share and competitiveness

    The WHO Annex 7 Stability of Reconstituted Lyophilized Products testing service involves a series of laboratory tests that assess the stability of reconstituted lyophilized products over time. The test conditions and methodology include:

  • Temperature: -20C to 30C

  • Humidity: 60 5

  • Pressure: Atmospheric pressure

  • Sample preparation: Reconstitution of lyophilized powder with distilled water

  • Testing parameters:

    • Potency or efficacy

    Appearance and color

    Odor and taste

    pH

    Moisture content

    The testing equipment and instruments used include:

  • Refrigerator for temperature control

  • Humidity chamber for humidity control

  • Balance for weighing samples

  • Spectrophotometer for measuring potency or efficacy

  • Colorimeter for measuring appearance and color

  • Olfactometer for measuring odor and taste

  • pH meter for measuring pH

    • The test procedure involves the following steps:

    1. Sample preparation: Reconstitution of lyophilized powder with distilled water.

    2. Temperature and humidity control: Samples are stored in a refrigerator or humidity chamber at the specified temperatures and humidities.

    3. Testing: Samples are tested for potency or efficacy, appearance and color, odor and taste, pH, and moisture content at regular intervals (e.g., 0, 1, 3, 6, 12 months).

    4. Data analysis: Results are analyzed to determine the stability of the product over time.

    Conclusion

    In conclusion, the WHO Annex 7 Stability of Reconstituted Lyophilized Products testing service is a critical component of ensuring the quality, safety, and efficacy of pharmaceutical products. Compliance with international and national standards is mandatory for organizations that want to ensure the quality, safety, and efficacy of their products.

    The test conditions and methodology involve a series of laboratory tests that assess the stability of reconstituted lyophilized products over time. The benefits of having this testing performed include improved product quality and safety, enhanced brand reputation, increased customer confidence and trust, and regulatory compliance benefits.

    We at Eurolab are committed to providing high-quality testing services that meet international and national standards. Our experienced team of scientists and technicians is dedicated to ensuring the accuracy and reliability of our test results.

    If you have any questions or would like more information about our WHO Annex 7 Stability of Reconstituted Lyophilized Products testing service, please do not hesitate to contact us.

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

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