EUROLAB
usp-1047-testing-for-biotechnological-protein-products
Pharmacopoeia-Based Assays BP Appendix VIII G: Total Ash in Herbal ProductsBP Appendix X: Identification Tests for Organic CompoundsBP Appendix XI C: Test for Water Insoluble MatterBP Appendix XII C: Uniformity of Weight TestBP Appendix XII F: Microbial Limits for Cosmetic PreparationsBP Appendix XII G: Total Aerobic Microbial Count in LiquidsBP Appendix XIV A: Refractive Index Measurement for OilsBP Appendix XIV C: Determination of pH Using ElectrodesBP Appendix XIV F: Assay of Sulphates by GravimetryBP Appendix XV B: Assay of Chloride in Raw MaterialsEP 2.2.2 UV-Visible Spectrophotometry AssayEP 2.2.20 Thin-Layer Chromatography Identity TestingEP 2.2.24 Absorption Spectrophotometry in the IR RegionEP 2.2.28 Gas Chromatography Method ValidationEP 2.2.3 Potentiometric pH MeasurementEP 2.2.32 Loss on Drying DeterminationEP 2.2.38 Differential Scanning Calorimetry AssayEP 2.4.4 Sulphated Ash for ExcipientsEP 2.4.8 Sulphated Ash AnalysisEP 2.5.12 Water Content (Karl Fischer Method)EP 2.6.12 Microbiological Examination of Non-Sterile ProductsEP 2.6.14 Microbiological Integrity Testing for PackagingEP 2.6.27 Bacterial Endotoxin Test Using Recombinant Factor CEP 2.9.1 Uniformity of Mass for Single-Dose PreparationsEP 2.9.3 Friability Testing for Uncoated TabletsEP 2.9.5 Hardness of Tablets MeasurementEP 2.9.7 Dissolution Testing for Gastro-resistant TabletsJP 3.01 Uniformity of Content in Powdered DrugsJP 3.03 Color and Clarity of Solution TestingJP 3.05 Osmolarity Testing in Ophthalmic SolutionsJP 4.01 Identification of Active Pharmaceutical IngredientsJP 4.04 Assay of Active Compounds Using UV MethodJP 4.05 Water Determination in Raw MaterialsJP 5.02 Determination of Peroxides in Lipophilic CompoundsJP 6.01 Test for Related Substances Using HPLCJP 6.03 Dissolution Test for Capsule Dosage FormsJP 6.04 Analysis of Pesticide Residues in Herbal MedicinesJP 6.05 Testing for Insoluble Matter in InjectionsJP 7.01 Test for pH in Oral SolutionsJP 7.02 Heavy Metal Test for Injection ProductsJP 8.02 Identity Testing Using IR SpectroscopyJP 8.03 Residual Solvents in APIsJP 9.01 Chromatographic Purity for Active SubstancesJP 9.04 Microbial Limits Test for OintmentsUSP <1029> Good Documentation Practices for TestingUSP <1030> Biological Assay for AntibodiesUSP <1032> Design and Conduct of Bioavailability StudiesUSP <1039> Reduced Sampling and Testing Plan JustificationUSP <1058> Analytical Instrument QualificationUSP <1062> Tablet and Capsule Weight Variation StudyUSP <1078> Good Manufacturing Practices for Bulk ExcipientsUSP <1079> Good Storage and Shipping Practices for Drug ProductsUSP <1088> Stability Testing of Drug SubstancesUSP <1092> Tablet Coating Performance TestingUSP <1106> Whole Package Integrity TestingUSP <1111> Microbiological Quality of Nonsterile ProductsUSP <1116> Control of Bioburden in Clean RoomsUSP <1117> Best Practices for Handling Hazardous CompoundsUSP <1163> Quality Assurance in Pharmaceutical CompoundingUSP <1181> Evaluation of Stability-Indicating MethodsUSP <1191> Stability Testing for Compounded PreparationsUSP <1216> Tablet Friability TestingUSP <121> Sterilization Assurance Level TestingUSP <1224> Transfer of Analytical ProceduresUSP <1225> Validation of Analytical ProceduresUSP <1226> Verification of Compendial ProceduresUSP <1227> Validation of Microbial Recovery from Pharm WatersUSP <1228> Depyrogenation Validation of EquipmentUSP <1231> Water for Pharmaceutical Purposes TestingUSP <231> Heavy Metals Limit Test for PharmaceuticalsUSP <232> Elemental Impurities – Limits in Finished ProductsUSP <233> Elemental Impurities – Procedures for AnalysisUSP <39-NF34> Identification Testing of Active Pharmaceutical IngredientsUSP <41> Weights and Balances Calibration CheckUSP <467> Residual Solvents Testing in Drug SubstancesUSP <51> Antimicrobial Effectiveness Testing in Aqueous FormulationsUSP <61> Microbial Enumeration Tests for Raw MaterialsUSP <62> Tests for Specified MicroorganismsUSP <701> Disintegration Test for Uncoated TabletsUSP <711> Dissolution Testing for Immediate-Release Dosage FormsUSP <788> Particulate Matter in Injections AnalysisUSP <800> Hazardous Drugs Handling ValidationUSP <800> Surface Contamination Testing for Hazardous DrugsUSP <857> UV-Visible Spectroscopy System SuitabilityUSP <85> Bacterial Endotoxins Test for Parenteral PreparationsUSP <905> Uniformity of Dosage Units for CapsulesUSP <905> Uniformity of Dosage Units Testing

USP <1047> Testing for Biotechnological Protein Products: A Comprehensive Guide

USP <1047> is a widely accepted standard for the testing of biotechnological protein products, ensuring their safety, efficacy, and quality. This article will delve into the world of USP <1047> testing, exploring its relevance, regulatory requirements, and technical specifications.

Relevant Standards

The United States Pharmacopeia (USP) is a non-profit organization that sets standards for pharmaceuticals, including biotechnological protein products. The USP <1047> standard is a comprehensive guideline for the testing of these products, ensuring their safety, efficacy, and quality.

  • ISO 11133:2014: This international standard outlines the requirements for the identification and characterization of microorganisms in pharmaceutical products.
  • ASTM E1713-02(2016): This American Society for Testing and Materials (ASTM) standard provides guidelines for the testing of biotechnological protein products, including their stability, purity, and potency.
  • EN ISO 11133:2014: This European standard is a harmonized version of the ISO 11133 standard, ensuring compliance with EU regulations.
  • Regulatory Framework

    The regulatory framework surrounding USP <1047> testing is governed by national and international standards. These regulations ensure that biotechnological protein products meet specific requirements for safety, efficacy, and quality.

  • US FDA: The United States Food and Drug Administration (FDA) enforces the regulations outlined in 21 CFR Part 211, which requires manufacturers to follow Good Manufacturing Practices (GMPs).
  • EU GMP: The European Unions Good Manufacturing Practice (EU GMP) regulations require manufacturers to adhere to specific guidelines for the production, control, and release of medicinal products.
  • Standard Development Organizations

    Standard development organizations play a crucial role in shaping the regulatory landscape. These organizations ensure that standards are developed and updated regularly to reflect emerging technologies and best practices.

  • USP: The United States Pharmacopeia (USP) is responsible for developing and maintaining standards for pharmaceuticals, including biotechnological protein products.
  • ISO: The International Organization for Standardization (ISO) develops and publishes international standards for various industries, including pharmaceuticals.
  • Standard Evolution

    Standards evolve over time to reflect emerging technologies, new research findings, and changing regulatory requirements. Regular updates ensure that standards remain relevant and effective in ensuring product safety, efficacy, and quality.

  • Revision cycles: Standards undergo revision cycles to incorporate new information, update technical specifications, or adjust testing methods.
  • Public consultation: Standard development organizations engage with stakeholders, including industry experts, researchers, and regulatory bodies, to gather feedback and ensure that standards meet emerging needs.
  • Standard Numbers and Scope

    USP <1047> is a comprehensive standard outlining the requirements for testing biotechnological protein products. The standard includes specific guidelines for:

  • Biotechnology-derived products: Products derived from recombinant DNA or cell fusion techniques.
  • Protein-based products: Products containing proteins, such as vaccines, therapeutic monoclonal antibodies, or gene therapy vectors.
  • Compliance Requirements

    Compliance with USP <1047> is essential for biotechnological protein product manufacturers to ensure the safety, efficacy, and quality of their products. Failure to comply may result in regulatory action, including fines, product recalls, or even facility shutdowns.

  • Quality assurance: Manufacturers must implement a robust quality assurance system to ensure compliance with USP <1047> requirements.
  • Regulatory submission: Manufacturers must submit documentation to regulatory authorities demonstrating compliance with USP <1047> standards.
  • Standard Compliance Requirements

    Biotechnological protein product manufacturers must comply with specific standards, including:

  • USP <1047>: The standard for testing biotechnological protein products.
  • ISO 11133:2014: The international standard for the identification and characterization of microorganisms in pharmaceutical products.
  • ASTM E1713-02(2016): The American Society for Testing and Materials (ASTM) standard for testing biotechnological protein products.
  • Why This Standard is Needed

    USP <1047> is essential for ensuring the safety, efficacy, and quality of biotechnological protein products. Failure to comply with this standard may result in:

  • Product recalls: Non-compliant products may be recalled from the market.
  • Regulatory action: Manufacturers may face fines, product seizures, or even facility shutdowns.
  • Loss of customer trust: Compliance failures can damage a companys reputation and erode customer confidence.
  • Business and Technical Reasons

    Manufacturers must comply with USP <1047> for business and technical reasons:

  • Product safety: Complying with USP <1047> ensures product safety, preventing adverse reactions or product-related harm.
  • Efficacy: Compliance with USP <1047> ensures product efficacy, ensuring that products meet their intended uses.
  • Quality: Complying with USP <1047> ensures product quality, maintaining consistency and purity.
  • Testing Methods

    USP <1047> outlines specific testing methods for biotechnological protein products, including:

  • Biotechnology-derived product identification: Manufacturers must identify the type of biotechnology used to produce the product.
  • Protein-based product characterization: Manufacturers must characterize the products protein content, ensuring it meets specific requirements.
  • Standard Compliance

    Manufacturers must ensure compliance with USP <1047> by implementing a robust quality assurance system. This includes:

  • Training programs: Employees must undergo training on USP <1047> standards and testing methods.
  • Documentation: Manufacturers must maintain accurate documentation demonstrating compliance with USP <1047> requirements.
  • Industry Experts

    Biotechnological protein product manufacturers must engage with industry experts to ensure compliance with USP <1047> standards:

  • Regulatory consultants: Companies can hire regulatory consultants to guide them through the compliance process.
  • Testing laboratories: Manufacturers may partner with testing laboratories specializing in biotechnology-derived products.
  • Conclusion

    USP <1047> is a comprehensive standard for the testing of biotechnological protein products. Compliance with this standard ensures product safety, efficacy, and quality, protecting manufacturers from regulatory action and maintaining customer trust. By understanding the technical specifications outlined in USP <1047>, manufacturers can ensure their products meet international standards.

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